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Massage, reflexology and other manual methods for pain management in labour

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Abstract

Background

Many women would like to avoid pharmacological or invasive methods of pain management in labour, and this may contribute towards the popularity of complementary methods of pain management. This review examined the evidence currently available on manual methods, including massage and reflexology, for pain management in labour. This review is an update of the review first published in 2012.

Objectives

To assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour.

Search methods

For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register (30 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017), the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trial Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017) and reference lists of retrieved trials.

Selection criteria

We included randomised controlled trials comparing manual methods with standard care, other non‐pharmacological forms of pain management in labour, no treatment or placebo. We searched for trials of the following modalities: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo‐skeletal manipulation, deep tissue massage, neuro‐muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We excluded trials for pain management relating to hypnosis, aromatherapy, acupuncture and acupressure; these are included in other Cochrane reviews.

Data collection and analysis

Two review authors independently assessed trial quality, extracted data and checked data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach.

Main results

We included a total of 14 trials; 10 of these (1055 women) contributed data to meta‐analysis. Four trials, involving 274 women, met our inclusion criteria but did not contribute data to the review. Over half the trials had a low risk of bias for random sequence generation and attrition bias. The majority of trials had a high risk of performance bias and detection bias, and an unclear risk of reporting bias. We found no trials examining the effectiveness of reflexology.

Massage

We found low‐quality evidence that massage provided a greater reduction in pain intensity (measured using self‐reported pain scales) than usual care during the first stage of labour (standardised mean difference (SMD) −0.81, 95% confidence interval (CI) −1.06 to −0.56, six trials, 362 women). Two trials reported on pain intensity during the second and third stages of labour, and there was evidence of a reduction in pain scores in favour of massage (SMD −0.98, 95% CI −2.23 to 0.26, 124 women; and SMD −1.03, 95% CI −2.17 to 0.11, 122 women). There was very low‐quality evidence showing no clear benefit of massage over usual care for the length of labour (in minutes) (mean difference (MD) 20.64, 95% CI −58.24 to 99.52, six trials, 514 women), and pharmacological pain relief (average risk ratio (RR) 0.81, 95% CI 0.37 to 1.74, four trials, 105 women). There was very low‐quality evidence showing no clear benefit of massage for assisted vaginal birth (average RR 0.71, 95% CI 0.44 to 1.13, four trials, 368 women) and caesarean section (RR 0.75, 95% CI 0.51 to 1.09, six trials, 514 women). One trial reported less anxiety during the first stage of labour for women receiving massage (MD ‐16.27, 95% CI −27.03 to −5.51, 60 women). One trial found an increased sense of control from massage (MD 14.05, 95% CI 3.77 to 24.33, 124 women, low‐quality evidence). Two trials examining satisfaction with the childbirth experience reported data on different scales; both found more satisfaction with massage, although the evidence was low quality in one study and very low in the other.

Warm packs

We found very low‐quality evidence for reduced pain (Visual Analogue Scale/VAS) in the first stage of labour (SMD −0.59, 95% CI −1.18 to −0.00, three trials, 191 women), and the second stage of labour (SMD −1.49, 95% CI −2.85 to −0.13, two trials, 128 women). Very low‐quality evidence showed reduced length of labour (minutes) in the warm‐pack group (MD −66.15, 95% CI −91.83 to −40.47; two trials; 128 women).

Thermal manual methods

One trial evaluated thermal manual methods versus usual care and found very low‐quality evidence of reduced pain intensity during the first phase of labour for women receiving thermal methods (MD −1.44, 95% CI −2.24 to −0.65, one trial, 96 women). There was a reduction in the length of labour (minutes) (MD −78.24, 95% CI −118.75 to −37.73, one trial, 96 women, very low‐quality evidence). There was no clear difference for assisted vaginal birth (very low‐quality evidence). Results were similar for cold packs versus usual care, and intermittent hot and cold packs versus usual care, for pain intensity, length of labour and assisted vaginal birth.

Music

One trial that compared manual methods with music found very low‐quality evidence of reduced pain intensity during labour in the massage group (RR 0.40, 95% CI 0.18 to 0.89, 101 women). There was no evidence of benefit for reduced use of pharmacological pain relief (RR 0.41, 95% CI 0.16 to 1.08, very low‐quality evidence).

Of the seven outcomes we assessed using GRADE, only pain intensity was reported in all comparisons. Satisfaction with the childbirth experience, sense of control, and caesarean section were rarely reported in any of the comparisons.

Authors' conclusions

Massage, warm pack and thermal manual methods may have a role in reducing pain, reducing length of labour and improving women's sense of control and emotional experience of labour, although the quality of evidence varies from low to very low and few trials reported on the key GRADE outcomes. Few trials reported on safety as an outcome. There is a need for further research to address these outcomes and to examine the effectiveness and efficacy of these manual methods for pain management.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Massage, reflexology and other manual methods for managing pain in labour

What is the issue?

This Cochrane review looked at whether massage, reflexology and other manual therapies would help with reducing pain and improve women's experiences of childbirth. We collected and analysed all the relevant trials to answer this question (search date: 30 June 2017).

Why is this important?

The pain of labour can be intense, with tension, anxiety and fear making it worse. Many women would like to labour without using drugs such as narcotics or epidurals, and are interested in complementary therapies to help them manage the pain of labour.

In this review we have looked to see if massage, reflexology and other manual methods are effective. Other complementary therapies like acupuncture, mind‐body techniques, hypnosis and aromatherapy have been studied in other Cochrane reviews. Massage involves manipulating the body's soft tissues and it can be done by the midwife or partner. It helps women relax and so reduces tension which in turn may reduce pain in labour. Reflexology is gentle manipulation or pressing on certain parts of the foot to produce an effect elsewhere in the body. Other manual methods include warm packs, osteopathy, shiatsu and zero balancing. It is important to examine if these therapies work and are safe, to enable women to make informed decisions about their care.

What evidence did we find?

This updated review now includes 14 trials. We were able to use data from 10 of the trials, involving a total of 1055 women. We found no trials on reflexology, osteopathy, shiatsu and zero balancing therapy.

In the various included trials, massage was given either by the woman's birth companion, a student midwife, a physiotherapist or a massage therapist (though some trials did not report who gave the massage). Three trials involved a two‐ to three‐hour prebirth course attended by women and their partners, and delivered by a qualified practitioner. In three trials, the intervention was delivered by a qualified health practitioner (massage therapist, physiotherapist or nurse/researcher with unspecified qualifications). In one trial, nurses taught women's partners in the labour ward. There was insufficient reporting of the qualifications of the practitioner teaching massage.

We found that massage and thermal packs, in comparison to usual care or music, may help women manage labour pain intensity during the first stage when the cervix is dilating. However, the quality of this evidence was very low. The effects of massage on assisted vaginal birth, caesarean section rate, the length of labour and use of drugs for pain relief were less clear, and the quality of the evidence was also very low. Two small trials showed increased satisfaction with childbirth, and a greater sense of control for women receiving massage.

Warm packs were associated with reduced pain in the first stage of labour and reduced length of labour (very low‐quality evidence).

What does this mean?

Massage may help women cope with pain in labour and may give them a better birth experience, and warm packs and thermal methods may help with pain. However, the quality of the evidence was generally low or very low, partly due to the trials being small and without sufficient numbers of women participating. These findings highlight a need for further research on this topic.

Authors' conclusions

Implications for practice

The limited data available suggest that massage may be a helpful modality for pain management in labour, and there is no evidence of harm. Overall, there are insufficient data to demonstrate whether massage provides an additive benefit when used in combination with usual care, or whether they are more effective than usual care. Due to the unclear risk of bias in the majority of trials, and the limited number of trials, further high‐quality research needs to be undertaken.

Implications for research

Additional randomised controlled trials of massage for pain management in labour are needed. Trials should be adequately powered and include clinically relevant outcomes such as those described in this review. A methodological issue for trials of massage is the choice of an appropriate control group. It may be difficult to blind participants and midwives in such trials, and pragmatic designs should be considered to enable meaningful comparisons to be made. There is a need to improve the quality and reporting in future trials. In particular, the analysis and reporting should consider the person providing the intervention; for example, their training, length of experience and relationship to the woman. In addition, further research is required that includes data measuring neonatal outcomes and other maternal, clinical and safety outcomes.

Summary of findings

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Summary of findings for the main comparison. Massage compared to usual care for pain management in labour

Massage compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital settings in Australia, Brazil, Canada, Iran, Taiwan, UK
Intervention: massage
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
( )

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with massage

Pain intensity — first stage of labour

The mean pain score in the massage group was 0.81 standard deviations lower
(1.06 lower to 0.56 lower)

362
(6 RCTs)

⊕⊕⊝⊝
LOW 1 2

Lower pain scores = less pain

Sense of control in labour

Seven point scale, 29 items range ‘1=almost always’, to ‘7=rarely’

The mean sense of control in labour was 150.92

MD 14.05 higher
(3.77 higher to 24.33 higher)

124
(1 RCT)

⊕⊕⊝⊝3
LOW

High score more control

Sense of control in labour (shortened Labour Agentry Scale).

Seven point scale range ‘1=almost always’, to ‘7=rarely’

The mean sense of control in labour (shortened Labour Agentry Scale) was 33.6

MD 6.1 lower
(11.68 lower to 0.52 lower)

56
(1 RCT)

⊕⊕⊝⊝
LOW 2 4

Low score more positive

Satisfaction with childbirth experience.

Five point scale, 5=more satisfaction

The mean satisfaction with childbirth experience was 3.7

MD 0.47 higher
(0.13 lower to 1.07 higher)

60
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 5

Higher score indicates greater satisfaction

Satisfaction with childbirth experience

Study population

RR 1.90
(1.07 to 3.38)

60
(1 RCT)

⊕⊕⊝⊝
LOW 2 4

333 per 1000

633 per 1000
(357 to 1000)

Assisted vaginal birth

Study population

RR 0.71
(0.44 to 1.13)

368
(4 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

191 per 1000

136 per 1000
(84 to 216)

Caesarean section

Study population

RR 0.75
(0.51 to 1.09)

514
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

191 per 1000

144 per 1000
(98 to 209)

Use of pharmacological pain relief

Study population

RR 0.81
(0.37 to 1.74)

368
(4 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

568 per 1000

460 per 1000
(210 to 989)

Length of labour (minutes)

The mean length of labour was 547.25 minutes

MD 20.64 minutes higher
(58.24 lower to 99.52 higher)

514
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6 7

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level due to massage being given for the first time during the trial by untrained personnel (indirectness).

2 Downgraded one level due to design limitations being present in most trials.

3 Downgraded two levels due to a single study with a small sample size.

4 Downgraded one level due to small sample size.

5 Downgraded two levels due to small sample size and wide confidence intervals that cross the line of no effect.

6 Downgraded one level due to wide confidence intervals that cross the line of no effect.

7 Downgraded one level due to high statistical heterogeneity.

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Summary of findings 2. Warm pack compared to usual care for pain management in labour

Warm pack compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital settings in Iran
Intervention: warm pack
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with warm pack

Pain intensity — first stage of labour

The mean pain score in the warm pack group was 0.59 standard deviations lower (1.18 lower to 0.00)

191
(3 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 3

Low scores = less pain

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth — not reported

Caesarean section — not reported

Use of pharmacological pain relief — not reported

Length of labour: minutes

The mean length of labour was 246.88 minutes

MD 66.15 minutes lower
(91.83 lower to 40.47 lower)

128
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 4 5

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded two levels due to serious design limitations in two trials contributing 66.9% weight to final analysis. One other trial with design limitations.

2 Downgraded two levels due to small sample size and wide confidence intervals just touching the line of no effect.

3 Downgraded one level due to high statistical heterogeneity.

4 Downgraded two levels due to one trial with serious design limitations contributing 68.4% weight to final analysis. One other trial with design limitations.

5 Downgraded one level due to small sample size.

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Summary of findings 3. Thermal manual methods compared to usual care for pain management in labour

Thermal manual methods compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital in Iran
Intervention: thermal manual methods
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with thermal manual methods

Pain intensity ‐ first stage of labour

The mean pain intensity was 6.9

MD 1.44 lower
(2.24 lower to 0.65 lower)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

Low score = less pain

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth

Study population

RR 0.52
(0.08 to 3.54)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 3

31 per 1000

16 per 1000
(3 to 111)

Caesarean section — not reported

Use of pharmacological pain relief — not reported

Length of labour: minutes

The mean length of labour was 273 minutes

MD 78.24 minutes lower
(118.75 lower to 37.73 lower)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded two levels due serious design limitations in one trial contributing data.

2 Downgraded one level due to small sample size.

3 Downgraded two levels due to small sample size, few events and wide confidence intervals that cross the line of no effect.

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Summary of findings 4. Massage compared to music for pain management in labour

Massage compared to music for pain management in labour

Patient or population: women in labour
Setting: hospital in Iran
Intervention: Massage
Comparison: music

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with music

Risk with massage

Pain intensity "severe pain reported"

Study population

RR 0.40
(0.18 to 0.89)

101
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

340 per 1000

136 per 1000
(61 to 303)

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth — not reported

Caesarean section — not reported

Use of pharmacological pain relief

Study population

RR 0.41
(0.16 to 1.08)

101
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 3

240 per 1000

98 per 1000
(38 to 259)

Length of labour — not reported

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level for design limitations in one trial contributing data.

2 Downgraded two levels for small sample size and few events.

3 Downgraded two levels for small sample size, few events, and wide confidence intervals just crossing the line of no effect.

Background

This review is one in a series of Cochrane reviews examining pain management in labour. An earlier version of this review contributed to an overview of systematic reviews of pain management for women in labour (Jones 2012) and shared a generic protocol (Jones 2011).

Description of the condition

Labour presents a physiological and psychological challenge for women. As labour becomes more imminent, this can be a time of conflicting emotions; fear and apprehension can be coupled with excitement and happiness. Pain associated with labour has been described as one of the most intense forms of pain that can be experienced (Melzack 1984), although conversely some women do not experience intense pain during labour. Labour involves three stages, relating to dilation of the cervix, birth of the baby and delivery of the placenta. The latent phase is the early part of labour when there are irregular contractions and little cervical dilation. The first stage of labour consists of regular contractions with increasing strength and frequency accompanied by more significant cervical dilation of at least 4 cm to 6 cm. Transition may or may not be observable anywhere between 7 cm to 8 cm and full dilation. The second stage of labour commences from full cervical dilation to the birth of the baby. The third stage of labour involves expulsion of the placenta.

The pain experienced by women in labour is caused by uterine contractions, the dilatation of the cervix and, in the late first stage and second stage, by stretching of the vagina and pelvic floor to accommodate the baby. Tension, anxiety and fear are factors contributing towards women's perception of pain and may also affect their labour and birth experience (Buckley 2003; Buckley 2015). The neuromatrix theory of pain understands the influence of many factors including past experience and memory (Melzack 2001; Seifert 2011; Trout 2004). In labour the theory of pain incorporates elements of the gate control theory, but also past experiences, cultural factors, emotional state, cognitive input, stress regulation and immune systems, as well as immediate sensory input (Buckley 2015; Trout 2004).

Effective and satisfactory pain management needs to be individualised for each woman, and may be influenced by two paradigms: 'working with pain', or 'pain relief' (Leap 1997; Leap 2010). The 'working with pain' paradigm includes the belief that there are long‐term benefits to promoting normal birth, and that pain plays an important role in this process. This approach offers support and encouragement to women, advocates the use of techniques such as immersion in water, comfortable positions and self‐help techniques to cope with normal labour pain. The 'pain relief' paradigm is characterised by the belief that no woman need suffer pain in labour and women are offered a variety of pharmacological pain relief options. However, the complete removal of pain does not necessarily mean a more satisfying birth experience for women (Morgan 1982). A follow‐up trial at five years after birth found those women who had epidurals were less positive about the birth five years later (Maimburg 2016).

The relationship between childbirth satisfaction, labour pain and analgesia is complex (Hodnett 2002). A systematic review by Hodnett 2002, which included two large population surveys, found that women who were very anxious about labour pain prenatally were less satisfied after the birth; and, secondly, women who were most satisfied were those who did not use pharmacological pain relief during labour. On the other hand, further trials indicate that women who experienced less labour pain report higher levels of childbirth satisfaction compared with women who report higher pain levels in labour (Waldenstrom 1999; Windridge 1999). However, labour pain is only one factor related to satisfaction with childbirth. Personal control and decision making are also related to satisfaction with the childbirth experience (Goodman 2004; Hodnett 2002; Martin 2013), and trials highlighted by (Leap 2010) describe women's experience of childbirth as difficult yet empowering, leading to achievement and a feeling of pride in their ability to cope with intense pain (Lundgren 1998;McCrea 2000; Niven 2000).

Description of the intervention

The Cochrane Complementary Medicine Field defines complementary and alternative medicine and therapies (CM) as 'practices and ideas which are outside the domain of conventional medicine in several countries', which are defined by its users as 'preventing or treating illness, or promoting health and well‐being' (Cochrane 2006). This definition is deliberately broad as therapies considered complementary practices in one country or culture may be conventional in another. Many therapies and practices are included within the scope of the Complementary Medicine Field.

CM has become popular with consumers worldwide. Women are the highest users of CM (Steel 2014). Many women would like to avoid pharmacological or invasive methods of pain relief in labour and this may contribute towards the popularity of complementary methods of pain management (Bennett 1999). A review of 14 trials with large sample sizes (more than 200 participants) on the use of CM in pregnancy identified a prevalence rate ranging from 1% to 87% (with nine trials falling between 20% and 60%) (Adams 2009). The review identified use of various complementary therapies including acupuncture and acupressure, aromatherapy, massage, yoga, homeopathy, and chiropractic care. The review also showed many pregnant women had used more than one complementary product or service (Adams 2009). According to an Australian survey (Steel 2012) almost half of pregnant women surveyed (49.4%) reported using at least one CM during pregnancy. The majority of women were seeking treatment for pain conditions during pregnancy, with many perceiving CM to be safer than conventional medicine, and equally effective. Some used CM as an adjunct therapy for conditions such as gestational diabetes (Steel 2012). In a review (Hall 2012) the most common indications for any CM referral were for labour induction and augmentation, nausea and vomiting, relaxation, back pain, anaemia, malpresentation, and other postnatal issues.

The most commonly cited CM practices associated with providing pain management in labour can be categorised into mind‐body interventions (e.g. yoga, hypnosis, relaxation therapies), traditional medical practice (e.g. homoeopathy, traditional Chinese medicine), manual methods (e.g. massage, reflexology), pharmacologic and biological treatments, bio‐electromagnetic applications (e.g. magnets) and herbal medicines. Manual methods used to manage pain in labour include massage and reflexology.

Massage involves manipulation of the body's soft tissues. It is commonly used to help relax tense muscles and to soothe and calm the individual. Massage may help to relieve pain by assisting with relaxation, inhibiting sensory transmission in the pain pathways or by improving blood flow and oxygenation of tissues (McNabb 2006). Massage therapy can include specific physical techniques or manual therapy, such as deep tissue work, Swedish massage, neuromuscular massage or shiatsu (Rich 2002). Different massage techniques may suit different women. A woman who is experiencing backache during labour may find massage over the lumbosacral area soothing. Some women find light abdominal massage, known as effleurage, comforting or stress‐relieving. Light stroking and soft touch have been associated with the release of oxytocin in response to low‐intensity stimulation of the skin (Uvnäs‐Moberg 2014). The pressure from massage may preempt the processing of painful stimuli because pressure fibres are longer and more myelinated, and relay signals to the brain more quickly than pain fibres (Melzack 1965). The potential positive effects from massage may decrease pain intensity, relieve muscle spasm, distract from pain, provide a sense of relaxation and reduce anxiety (McCaffery 1989). Additionally, hormonal activation of oxytocin or regulation of cortisol may contribute to the effect (Uvnäs‐Moberg 2014). Research by Field demonstrates that massage therapy using moderate pressure is associated with a decrease in cortisol and an increase in serotonin and dopamine (Field 2005). The hormonal regulatory effects of massage have been shown to last several days and are dose dependent (Rapaport 2012). Massage therapists generally hold certification or licensure to practice massage in those countries or jurisdictions where such qualifications are recognised. Professional training programs for massage therapists also vary from country to country and may be undertaken as part of a broader health professional training or as a profession in its own right (Rich 2002).

Reflexologists propose that there are reflex points on the feet corresponding to organs and structures of the body, and that pain may be reduced by gentle manipulation or pressing certain parts of the foot. Reflexology differs from massage in that contact is more superficial and pressure is deeper on the specific points (Wang 2008). Pressure applied to the feet has been shown to result in an anaesthetising effect on other parts of the body (Ernst 1997). Reflexology involves the application of the thumb and forefinger to apply deep pressure to specific areas of the feet that are claimed to correspond to internal organs, glands and other parts of the body (Botting 1997). It has been claimed that by applying pressure to 'reflex zones', energy blocks or disturbances such as calcium, lactate or uric acid crystals are reabsorbed and later eliminated. This process is more commonly known as detoxification (Botting 1997; Wang 2008). It has also been proposed that reflexology may reduce stress, tension and maintain balance or homeostasis.

The application of pressure also includes thermal methods and heat packs. The warm packs are generally applied to the perineum in second stage and the thermal packs may be applied to various points on the body for pain relief during labour and birth. This review includes the use of thermal packs applied with pressure, but excludes the use of warm perineal compresses, a Cochrane review on this topic has been conducted (Aasheim 2017).

Other manual therapies include a variety of musculo‐skeletal massage and manipulation therapies. They are often divided into myofascial (‘soft tissue’) and manipulative (‘joint‐based’) with outcomes focusing on measures of pain, function and autonomic activation. Research has suggested that it is the therapeutic stimulation of the fascia throughout the body that provides benefit and these may be similar across the different modalities of therapy (Simmonds 2012). Some of the different modalities are described as follows.

Chiropractic care in pregnancy focuses on gentle myofascial relaxation around the pelvic muscles and joints and correction of spinal tilt and pressure, and adjustments, commonly known as Webster Technique, are also used to relieve pelvic constraint (Borggren 2007). Chiropractic care is commonly used for lower back and pelvic pain in pregnancy, and is the third most commonly sought treatment modality for during pregnancy, according to a 2005 survey conducted in the USA (Wang 2005). In a review of the literature on chiropractic care in pregnancy (Borggren 2007), the authors state that chiropractic care is commonly used for treating common musculo‐skeletal symptoms during pregnancy and facilitation of uncomplicated labours.

Osteopathy focuses on functional movement of the body as a whole to stimulate the body’s regulatory mechanisms and has a long tradition of use during pregnancy (King 2003). Osteopathic manipulative treatment (OMT) aims to restore the body's balance and release pain, with techniques typically including stretching and massage for general treatment of the soft tissues and mobilisation of specific joints and soft tissue using adjustment (Posadzki 2011).

Neuro‐muscular therapy is a form of massage therapy used in the management of conditions where muscle tension and fatigue are prominent (Craig 2006).

Shiatsu, which means literally means 'finger pressure', has its origins in Japan and is similar to acupressure in its use of finger pressure to affect the balance of energy through acupoints (Long 2009). Shiatsu incorporates manipulation and stretches, along Traditional Chinese Medicine meridians (Robinson 2011).

Tuina, which translates literally to 'pinch and pull', is a form of therapeutic massage and bodywork in Traditional Chinese Medicine (TCM). Tuina is used for treatment of specific patterns of disharmony according to the same principles of TCM and varies widely in practice. Tuina manipulations involve sufficiently strong mechanical stimulation to muscle and tissue activating sensory and spinal nerves to stimulate physiological and biomechanical changes for a healing response (Fang 2013).

Trigger point, or myofascial trigger point therapy, is a form of remedial massage where direct and sustained pressure is applied to specific points on tender muscle tissue to reduce tension and pain. The trigger points are hard nodular structures within the muscle or fascia, located within a taut band of muscle fibres, and have histologically distinct markers (Janssens 1992). Muscles with trigger points are weaker than normal muscles, and are unable to move through the normal range of motion. They consequently recruit surrounding muscles, which can cause pain and further weakness in other areas. Muscles with active trigger points can occur due to overuse, inflammation, trauma, electrolyte imbalances, infections and nerve pain. They are commonly found around the neck and shoulders and arms (Dommerholt 2012).

Myotherapy is a form of manual therapy focusing on myofascial pain and dysfunction, from the muscles and surrounding connective tissue. The therapy focuses on musculoskeletal pain and rehabilitation, using trigger point therapy, massage and manipulation of muscles (Nagata 1997).

Zero balancing is form of touch and energetic therapy, including electromagnetic fields (Greggus 2004), that aims to balance the relationship of the energy and structure of the bones and the deep tissues of the body (Denner 2009).

The intent is for these interventions to be included as separate reviews in the future.

How the intervention might work

Massage and reflexology are two techniques that may reduce pain by interrupting the transmission of pain signals, modifying pain perception, stimulating the release of endorphins or neurochemicals, or emotional regulation (Buckley 2015; Field 2007; Field 2010; Wang 2008). Recently, trials of massage have been linked to mediation of pain and pain perception through the activation of sensory nerves, and release of oxytocin (Uvnäs‐Moberg 2014). Research proposes that the underlying mechanism of action is through increased vagal activity, where baroreceptors under the skin are innervated by the afferent fibres of the vagus nerve, leading to regulation of the autonomic nervous system (Field 2010). Magnetic Resonance Imaging (MRI) shows increases blood flow to the amygdala and hypothalamus, which are involved in regulation of the autonomic nervous system, as well as cortisol reduction and emotional regulation (Field 2010). For massage involving strong pressure, the gate theory proposed by Melzac suggests that pain signals are blocked by strong pressure on muscles, and that the signals along myelinated fibres travel to the brain more quickly (Melzack 1965).

Reflexology proposes an effect in promoting homeostasis, relaxation and detoxification by stimulating reflex zones on the foot that correspond with internal organs and glands of the body (Wang 2008).

Literature supports the benefits of warm/thermal packs through dilation of blood vessels, increased blood supply, affecting transmission of pain by reducing nociceptive stimulation and increasing collagen extensibility (Hayes 2000; Porth 1990).

Why it is important to do this review

There is interest from women to use additional forms of care to assist with pain management in labour. It is important to examine the effect, safety and acceptability of currently under‐evaluated forms of treatment to enable women, health providers and policy makers to make informed decisions about care. This is an update of a review first published in 2012 (Smith 2012).

Objectives

To assess the effect, safety and acceptability of massage, reflexology and other manual methods to manage pain in labour.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs), quasi‐RCTs and cluster RCTs. We included trials only presented as abstracts if additional information was obtained from the author on the methods and results.

Types of participants

Women in labour. (This includes women in high‐risk groups, e.g. preterm labour or following induction of labour. We planned to use subgroup analysis for any possible differences in the effect of interventions in these groups.)

Types of interventions

The previous version of this review (Smith 2012) contributed to an overview of systematic reviews of interventions for pain management in labour (Jones 2012), and shared a generic protocol (Jones 2011). To avoid duplication, the different methods of pain management were listed in a specific order, from one to 15. Individual reviews focusing on particular interventions included comparisons with only the intervention above it on the list. The list is as follows.

  1. Placebo/no treatment.

  2. Hypnosis (Madden 2016).

  3. Biofeedback (Barragán 2011).

  4. Intracutaneous or subcutaneous sterile water injection (Derry 2011).

  5. Immersion in water (Cluett 2009).

  6. Aromatherapy (Smith 2011b).

  7. Relaxation techniques (yoga, music, audio) (Smith 2011c).

  8. Acupuncture or acupressure (Smith 2011a).

  9. Manual methods (massage, reflexology) (this review).

  10. Transcutaneous electrical nerve stimulation (Dowswell 2009).

  11. Inhaled analgesia (Klomp 2011).

  12. Opioids (Ullman 2010).

  13. Non‐opioid drugs (Othman 2011).

  14. Local anaesthetic nerve blocks (Novikova 2011).

  15. Epidural (including combined spinal epidural) (Anim‐Somuah 2005; Simmons 2007).

In this review we included the following manual methods: massage, warm packs, thermal manual methods, reflexology, chiropractic, osteopathy, musculo‐skeletal manipulation, deep tissue massage, neuro‐muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing. We included comparisons of any type of manual healing method with any other type of manual healing method, as well as any type of manual healing method compared with: 1) placebo/no treatment; 2) hypnosis; 3) biofeedback; 4) intracutaneous or subcutaneous sterile water injection; 5) immersion in water; 6) aromatherapy; 7) relaxation techniques (yoga, music, audio); or 8) acupuncture or acupressure.

Types of outcome measures

This review is one in a series of Cochrane reviews examining pain management in labour. The following list of primary outcomes are the ones which are common to all the reviews, as specified in the generic protocol (Jones 2011).

Primary outcomes
Effects of interventions

  • Pain intensity (as defined by trialists).

  • Satisfaction with pain relief (as defined by trialists).

  • Sense of control in labour (as defined by trialists).

  • Satisfaction with childbirth experience (as defined by trialists).

Safety of interventions

  • Effect (negative) on mother/baby interaction.

  • Breastfeeding (at specified time points).

  • Assisted vaginal birth.

  • Caesarean section.

  • Side effects (for mother and baby; review specific).

  • Admission to special care baby unit/neonatal intensive care unit (as defined by trialists).

  • Apgar score less than seven at five minutes.

  • Poor infant outcomes at long‐term follow‐up (as defined by trialists).

Other outcomes

  • Cost (as defined by trialists).

Secondary outcomes
Maternal

Use of pharmacological pain relief in labour; length of labour; need for augmentation with oxytocin; perineal trauma (defined as episiotomy and incidence of second or third degree tear); and maternal blood loss (postpartum haemorrhage defined as greater than 500 mL), women's emotional experience of the intervention.

Neonatal

Need for mechanical ventilation; neonatal encephalopathy.

Search methods for identification of studies

The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth.

Electronic searches

We searched Cochrane Pregnancy and Childbirth's Trials Register by contacting their Information Specialist (30 June 2017).

The Register is a database containing over 24,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate Pregnancy and Childbirth’s Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL; the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link to the editorial information about the Cochrane Pregnancy and Childbirth in the Cochrane Library and select the 'Specialized Register' section from the options on the left side of the screen.

Briefly, Cochrane Pregnancy and Childbirth's Trials Register is maintained by their Information Specialist and contains trials identified from:

  1. monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE (Ovid);

  3. weekly searches of Embase (Ovid);

  4. monthly searches of CINAHL (EBSCO);

  5. handsearches of 30 journals and the proceedings of major conferences;

  6. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Search results are screened by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth review topic (or topics), and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set that has been fully accounted for in the relevant review sections (Included studies; Excluded studies; Studies awaiting classification; Ongoing studies).

In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6) in the Cochrane Library (searched 30 June 2017), MEDLINE (1966 to 30 June 2017, CINAHL (1980 to 30 June 2017). See Appendix 1, Appendix 2, and Appendix 3 for search strategies used.

We also searched the following clinical trial registries for ongoing trials: the Australian New Zealand Clinical Trials Registry (4 August 2017), Chinese Clinical Trials Registry (4 August 2017), ClinicalTrials.gov, (4 August 2017), the National Center for Complementary and Integrative Health (4 August 2017), and the WHO International Clinical Trials Registry Platform (ICTRP) (4 August 2017). See Appendix 4 for search terms used.

Searching other resources

We searched the reference lists of retrieved trials. We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous version of this review, see Smith 2012.

For this update, the following methods were used for assessing the 47 reports that were identified as a result of the updated search.

The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth.

Selection of studies

Two review authors independently assessed for inclusion all the potential trials identified as a result of the search strategy. We resolved any disagreement through discussion or, if required, we consulted the third review author.

Data extraction and management

We designed a form to extract data. For eligible trials, two review authors extracted the data using the agreed form. We resolved discrepancies through discussion or, if required, we consulted the third review author. Data were entered into Review Manager software (RevMan 2014) and checked for accuracy.

When information regarding any of the above was unclear, we planned to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each trial using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Any disagreement was resolved by discussion or by involving a third assessor.

(1) Random sequence generation (checking for possible selection bias)

We described for each included trial the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as:

  • low risk of bias (any truly random process, e.g. random number table; computer random number generator);

  • high risk of bias (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number);

  • unclear risk of bias.

(2) Allocation concealment (checking for possible selection bias)

We described for each included trial the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as:

  • low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

  • high risk of bias (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);

  • unclear risk of bias.

(3.1) Blinding of participants and personnel (checking for possible performance bias)

We described for each included trial the methods used, if any, to blind trial participants and personnel from knowledge of which intervention a participant received. We considered that trials were at low risk of bias if they were blinded, or if we judged that the lack of blinding unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as:

  • low, high or unclear risk of bias for participants;

  • low, high or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible detection bias)

We described for each included trial the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

  • low, high or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

We described for each included trial, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or could be supplied by the trial authors, we planned to re‐include missing data in the analyses which we undertook.

We assessed methods as:

  • low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);

  • high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; 'as treated' analysis done with substantial departure of intervention received from that assigned at randomisation);

  • unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

We described for each included trial how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed the methods as:

  • low risk of bias (where it is clear that all of the trial's pre‐specified outcomes and all expected outcomes of interest to the review have been reported);

  • high risk of bias (where not all the trial's pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest are reported incompletely and so cannot be used; trial fails to include results of a key outcome that would have been expected to have been reported);

  • unclear risk of bias.

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

We described for each included trial any important concerns we had about other possible sources of bias.

(7) Overall risk of bias

We made explicit judgements about whether trials were at high risk of bias, according to the criteria given in the Handbook (Higgins 2011). With reference to (1) to (6) above, we planned to assess the likely magnitude and direction of the bias and whether we considered it is likely to impact on the findings. In future updates, we will explore the impact of the level of bias through undertaking sensitivity analyses; see Sensitivity analysis.

Assessment of the quality of the evidence using the GRADE approach

For this update the quality of the evidence was assessed using the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the body of evidence relating to the following outcomes, where data were available.

  • Pain intensity (as defined by trialists).

  • Sense of control in labour.

  • Satisfaction with childbirth experience.

  • Assisted vaginal birth.

  • Caesarean section.

  • Use of pharmacological pain relief in labour.

  • Length of labour.

We used the GRADEpro Guideline Development Tool to import data from Review Manager 5 (RevMan 2014) in order to create 'Summary of findings' tables. A summary of the intervention effect and a measure of quality for each of the above outcomes was produced using the GRADE approach. The GRADE approach uses five considerations (trial limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates or potential publication bias.

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results as summary risk ratios (RRs) with 95% confidence intervals (CIs).

Continuous data

We used the mean difference (MD) if outcomes were measured in the same way between trials. We used the standardised mean difference (SMD) to combine trials that measured the same outcome, but used different methods.

Unit of analysis issues

We included three trials with multiple arms (Ganji 2013a; Kimber 2008; Mortazavi 2012); these are described in the Characteristics of included studies tables. In Ganji 2013a there were four groups, three of which were intervention groups: (cold pack versus intermittent hot and cold packs versus heat packs only versus a control of routine care). We included the heat pack versus usual care arms in comparison 2 of our review, and we disregarded the other two of the arms of the trial, in accordance with methods in the Cochrane Handbook (section 16.5.4). In comparison 3 of our review, we included three arms of the trial and disregarded the heat pack arm, so there were comparisons of: 1) cold packs versus usual care; and 2) intermittent hot and cold packs versus usual care; we split the 'usual care' group between the two comparisons, a method described in the Cochrane Handbook (section 16.5.4) (Higgins 2011). Both Kimber 2008 and Mortazavi 2012 each included three arms. In Kimber 2008 there were three arms: massage and relaxation versus placebo and relaxation techniques and music verus usual care. We disregarded the placebo group from the Kimber 2008 trial, because this is included in a separate Cochrane review on relaxation techniques, and only included the massage and relaxation versus usual care group arms (comparison 1 of our review). In Mortazavi 2012 there were three arms: massage versus control group 1 with attendant versus control group 2. However, the data were only reported narratively and so there were no data included in meta‐analysis.

Cluster‐randomised trials

If we identified cluster‐randomised trials we planned to include them in the analyses along with individually randomised trials. If such trials are identified in future updates we will adjust their sample sizes using the methods described in the Cochrane Handbook using an estimate of the intracluster correlation coefficient (ICC) derived from the trial (if possible), from a similar trial or from a trial of a similar population. If we use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the trial designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely.

We will also acknowledge heterogeneity in the randomisation unit and perform asubgroup analysis to investigate the effects of the randomisation unit.

Cross‐over trials

We have excluded cross‐over trials because they not a suitable design for trials looking at interventions in labour.

Dealing with missing data

We noted levels of attrition for included trials. If more eligible trials are included in future updates of this review, we will use sensitivity analysis to explore the impact of including trials with high levels of missing data in the overall assessment of treatment effect.

For all outcomes, analyses were carried out, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta‐analysis using the Tau2, I2 and Chi2 statistics. We regarded heterogeneity as substantial if I2 was greater than 30% and either Tau2 was greater than zero, or there was a low P value (less than 0.10) in the Chi2 test for heterogeneity. If we identified substantial heterogeneity (above 30%), we planned to explore it using prespecified subgroup analysis.

Assessment of reporting biases

In future updates, we will investigate reporting biases (such as publication bias) using funnel plots if there are 10 or more trials in the meta‐analysis. We will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using the Review Manager software (RevMan 2014). We used fixed‐effect meta‐analysis for combining data where it was reasonable to assume that trials were estimating the same underlying treatment effect, i.e. where trials were examining the same intervention, and the trials' populations and methods were judged sufficiently similar.

If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random‐effects meta‐analysis to produce an overall summary if an average treatment effect across trials was considered clinically meaningful. The random‐effects summary will be treated as the average range of possible treatment effects and we will discuss the clinical implications of treatment effects differing between trials. If the average treatment effect is not clinically meaningful, we will not combine trials. If we used random‐effects analyses, the results were presented as the average treatment effect with 95% CIs, and the estimates of Tau2 and I2.

Subgroup analysis and investigation of heterogeneity

We planned to investigate substantial heterogeneity using subgroup analyses. We considered heterogeneity as substantial if Tau2 was greater than zero and either I2 was greater than 30% or there was a low P value (less than 0.10) in the Chi2 test for heterogeneity. We considered whether an overall summary was meaningful, and if it was, used a random‐effects analysis.

We planned to carry out the following subgroup analyses.

  1. Spontaneous labour versus induced labour.

  2. Primiparous versus multiparous.

  3. Term versus preterm birth.

  4. Continuous support in labour versus no continuous support.

We planned to visually examine the forest plots of subgroup analyses to look at whether there was overlap between 95% CIs for the effects of different groups; with non‐overlapping CIs suggesting a difference between subgroups. We planned to report the results of subgroup analyses quoting the Chi2 statistic and P value, and the interaction test I2 value. There were insufficient trials in this update to allow for these additional analyses.

Sensitivity analysis

We planned to conduct sensitivity analyses to explore the effect of risk of bias for each comparison by restricting analysis to those trials rated as 'low risk of bias' for random sequence generation and allocation concealment. In this version of the review there were too few trials in any one comparison (with design limitations) contributing data and so we did not carry out this additional analysis. Iif sufficient data become available to carry out sensitivity analysis in future updates, we will limit analyses to the primary outcomes. We carried out sensitivity analyses to explore the impact of including quasi‐RCTs in the analyses. We excluded quasi‐RCTs from the analyses to see if this made any difference to the overall result.

Results

Description of studies

Results of the search

The search retrieved 47 potentially eligible trial reports (see Figure 1). We also reassessed the four trials listed as awaiting further classification and ongoing in the previous version of the review (Smith 2012). This updated review includes massage trials only. We found no trials of reflexology which were eligible for inclusion. We included eight new trials (Behmanesh 2009; Bolbol‐Haghighi 2016; Ganji 2013a; Janssen 2008; Levett 2016; Mortazavi 2012; Silva 2013; Taavoni 2013;) and excluded 10 trials.


Trial flow diagram.

Trial flow diagram.

In total, 14 trials are now included, 11 excluded, 14 are awaiting further classification and 3 are ongoing. See Characteristics of included studies, Characteristics of excluded studies, Characteristics of studies awaiting classification and Characteristics of ongoing studies.

Our search found no trials on the following interventions; reflexology, chiropractic, osteopathy, musculo‐skeletal manipulation, deep tissue massage, neuro‐muscular therapy, shiatsu, tuina, trigger point therapy, myotherapy and zero balancing.

Included studies

This review now includes 14 trials, involving 1172 women. Four of these trials, involving 274 women (Abasi 2009; Behmanesh 2009; Field 1997; Mortazavi 2012), did not contribute data to the review.

Trial design

All trials used parallel design. Eleven trials included two groups; two trials included three groups (Kimber 2008; Mortazavi 2012); and one trial included four groups (Ganji 2013a). All used active controls, including standard care (Abasi 2009; Behmanesh 2009; Bolbol‐Haghighi 2016; Chang 2002; Janssen 2008; Karami 2007; Kimber 2008; Levett 2016; Mortazavi 2012; Silva 2013; Taavoni 2013), breathing exercises (Field 1997), presence of an attendant (Mortazavi 2012), a cold pack (Ganji 2013a) and music (Kimber 2008; Taghinejad 2010).

Sample size

The number of participants in the included trials ranged from 28 (Field 1997) to 176 (Levett 2016).

Trial location and sources of women

Eight trials were undertaken in Iran (Abasi 2009; Behmanesh 2009; Bolbol‐Haghighi 2016; Ganji 2013a; Karami 2007; Mortazavi 2012; Taavoni 2013; Taghinejad 2010), and one trial each in Taiwan (Chang 2002), Canada (Janssen 2008), Australia (Levett 2016), Brazil (Silva 2013) United Kingdom (Kimber 2008) and the USA (Field 1997).

Participants

Ten trials recruited primiparous women only (Abasi 2009; Behmanesh 2009; Chang 2002; Ganji 2013a; Janssen 2008; Karami 2007; Levett 2016; Silva 2013; Taavoni 2013; Taghinejad 2010), one recruited multiparous women only (Mortazavi 2012), and the remaining trials did not specify parity (Bolbol‐Haghighi 2016; Field 1997; Kimber 2008). Most trials only included women at term (Abasi 2009; Behmanesh 2009; Chang 2002; Janssen 2008; Karami 2007; Mortazavi 2012; Silva 2013; Taavoni 2013). Three trials (Kimber 2008; Field 1997; Levett 2016) recruited women prior to 37 weeks' gestation from an antenatal clinic. Two trials recruited women in labour but did not report gestational age (Bolbol‐Haghighi 2016; Taghinejad 2010).

Types of intervention

In three trials massage was taught to the partner who applied massage during labour (Chang 2002; Field 1997; Kimber 2008). It was unclear who applied massage in the Karami 2007 and Taghinejad 2010 trials. Massage was administered by a masseuse in two studies (Abasi 2009; Janssen 2008), and by a physiotherapist in one study (Silva 2013). There was variation in the frequency, duration and technique in how the massage was applied. In three studies (Abasi 2009; Bolbol‐Haghighi 2016; Chang 2002) massage was delivered 30 minutes during each phase of labour using a variety of massage techniques. Massage was applied during contractions for a total of 30 minutes (no technique specified) in Taghinejad 2010. One study (Kimber 2008) administered pre‐birth training taught by an accredited massage therapist to partners. The partner delivered slow rhythmic long stroke massage, with the hands moving up and down with slow rhythmic breathing, and in Mortazavi 2012 firm rhythmic massage was used on the shoulders, back, abdomen and sacrum for 30 minutes in all three phases of labour. Effleurage was applied in Karami 2007 (no other details were reported). In the trial by Field 1997, trial partners were trained to deliver massage involving a 20‐minute sequence of stroking movements around five regions including head, neck, shoulder, back and foot, from 3 cm to 5 cm dilation. In Levett 2016, an antenatal education package was delivered to women and their birth partners with a variety of therapies including massage, yoga, breathing, acupressure and relaxation/visualisation. One study (Behmanesh 2009) applied heat packs to the lower back during the first stage of labour and to the perineum during the second stage. Heat and ice packs were applied by a doula in Ganji 2013a.

Outcome measures

The following primary outcomes were reported in the trials: pain intensity (Abasi 2009; Behmanesh 2009; Chang 2002; Ganji 2013a; Janssen 2008; Kimber 2008; Silva 2013; Taavoni 2013; Taghinejad 2010); satisfaction with the childbirth experience (Chang 2002; Kimber 2008); sense of control in labour (Levett 2016; Kimber 2008); assisted vaginal birth (Ganji 2013a; Janssen 2008; Karami 2007; Kimber 2008; Levett 2016); caesarean section rate (Bolbol‐Haghighi 2016; Janssen 2008; Karami 2007; Kimber 2008; Levett 2016; Silva 2013); admission to neonatal intensive care (Kimber 2008; Levett 2016).

The following secondary outcomes were reported in the following trials: use of pharmacological pain relief (Chang 2002; Janssen 2008; Kimber 2008; Levett 2016; Taghinejad 2010); augmentation (Bolbol‐Haghighi 2016; Chang 2002; Ganji 2013a; Janssen 2008; Kimber 2008; Levett 2016); length of labour (Bolbol‐Haghighi 2016; Chang 2002; Janssen 2008; Kimber 2008; Levett 2016; Silva 2013); emotional experience of labour (anxiety) (Chang 2002); spontaneous vaginal birth (Bolbol‐Haghighi 2016; Janssen 2008, Kimber 2008; Levett 2016); Apgar score less than seven at five minutes (Levett 2016; Silva 2013); postpartum haemorrhage (Levett 2016): resuscitation of newborn (Kimber 2008; Levett 2016); and perineal trauma (Ganji 2013a; Levett 2016).

Date of the trials

Trials took place between 1999 and 2015. Two trials did not report on trial dates (Field 1997; Janssen 2008). The majority of trials reported a trial duration of two years.

Funding

Nine trials reported their funding sources. Bolbol‐Haghighi 2016 reported funding from the Research Deputy of the Shahroud University of Medical Sciences. Field 1997 reported funding from the National Institute of Mental Health (NIMH) Research Scientist Award (#MH00331) and NIMH Research Grant (#MH46586) and a grant from Johnson & Johnson. Ganji 2013a reported funding from the Research Deputy of Mazandaran University of Medical Sciences (project number H89‐26). Janssen 2008 reported funding from the Holistic Health Research Foundation of Canada, Massage Therapy Foundation, and Massage Therapists' Association of BC. Kimber 2008 received grant funding from Oxfordshire Health Services Research Committee (OHSRC). Levett 2016 received funding associated with an Australian Postgraduate Award, and a postgraduate stipend from the Western Sydney University. Mortazavi 2012 reported receiving funding associated with a student Scientific Research Center of Tehran University of Medical Sciences and Health Services grant. Silva 2013 reported receiving funding from CNPQ, who provided the master's degree scholarship and aided in the development of this trial. Taavoni 2013 was funded by the Researches Department of Tehran University of Medical Sciences.

Declarations of Interest

Six trials reported no declarations of interest (Bolbol‐Haghighi 2016; Ganji 2013a; Janssen 2008; Levett 2016; Mortazavi 2012; Taghinejad 2010. The remaining trials did not report whether any conflicts of interest were present. We note that Janssen 2008 reported no conflict of interest despite being funded by the Massage Therapy Foundation and the Massage Therapists' Association.

Excluded studies

We excluded 11 trials (see Characteristics of excluded studies). We excluded two trials as it was not clear whether they were randomised controlled trials (Dehcheshmeh 2015; Hajiamini 2012). Eight trials did not meet the inclusion criteria for 'types of interventions' and examined interventions that are included in other pain management systematic reviews of acupressure (Akbarzadeh 2014; Bastani 2016; Mafetoni 2015; Ozgoli 2016; Torkzahrani 2017), aromatherapy (Fili 2017; Nourbakhsh 2012) and relaxation (Yildirim 2004) (included in Smith 2011c). We excluded one trial because it compared reflexology plus saline infusion versus routine care plus saline infusion plus oxytocin, which we assessed as not being a valid comparison for this review (Valiani 2010).

Risk of bias in included studies

See Figure 2 and Figure 3 for graphical summaries of our 'Risk of bias' bias assessments based on the seven 'Risk of bias' domains. We did not judge any trial to have a low risk of bias for all domains.


'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included trials.

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included trials.


'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.

Allocation

Method of allocation

We rated nine trials as having low risk of bias for method of randomisation: three trials used a random number table (Bolbol‐Haghighi 2016; Field 1997; Karami 2007); one trial used ball tossing (Chang 2002); and five trials used computer generation (Janssen 2008; Kimber 2008; Levett 2016; Silva 2013; Taghinejad 2010). We rated three trials as having high risk of bias because they used quasi‐randomised methods for randomisation, such as date of admission, alternate allocation and day of the week (Abasi 2009; Behmanesh 2009; Mortazavi 2012). The risk of bias was unclear in two trials (Ganji 2013a; Taavoni 2013) due to unclear reporting.

Allocation concealment

We judged the method of allocation concealment to have low risk of bias in four trials: sealed envelopes were used in two trials (Janssen 2008; Karami 2007); and randomisation was concealed centrally in two trials (Levett 2016; Silva 2013). Three trials were at high risk of bias as they used methods for allocation that could have enabled investigators enrolling participants to possibly foresee assignments (Abasi 2009; Behmanesh 2009; Mortazavi 2012). We assessed seven trials as having unclear risk of bias for this domain, due to no or insufficient reporting (Bolbol‐Haghighi 2016; Chang 2002; Field 1997; Ganji 2013a; Kimber 2008; Taavoni 2013; Taghinejad 2010).

Blinding

It is difficult to conceal some of these manual methods from participants and clinicians. We did not assess any trial as being at low risk of bias for this domain. We assessed 12 trials as having high risk of performance bias, due to there being no blinding of the women who completed subjective outcomes (Abasi 2009; Behmanesh 2009; Bolbol‐Haghighi 2016; Chang 2002; Field 1997; Ganji 2013a; Janssen 2008; Karami 2007; Kimber 2008; Mortazavi 2012; Silva 2013; Taavoni 2013). We assessed two trials as having unclear risk of bias. We judged Levett 2016 to have unclear risk of bias because women were aware of their treatment allocation, but the control group were not aware of the course content. It was also reported that staff providing care at the birth were not aware of treatment group, and were not aware of course content, but may have provided support with techniques if known. We assessed Taghinejad 2010 as having unclear risk of bias due to participants not being blinded, and the blinding status of caregivers being unclear.

For detection bias, we judged five trials as having low risk of bias, because the outcome assessor was blind to group allocation (Abasi 2009; Field 1997; Levett 2016; Silva 2013; Taghinejad 2010). We assessed seven trials as having high risk of bias, because assessors were involved with the delivery of the intervention and undertook outcome assessment, or there was no blinding of the intervention (Behmanesh 2009; Bolbol‐Haghighi 2016; Ganji 2013a; Janssen 2008; Karami 2007; Kimber 2008; Taavoni 2013). We assigned two trials as having unclear risk of bias for this domain due to insufficient reporting (Chang 2002; Mortazavi 2012).

Incomplete outcome data

We assessed attrition bias as 'low' risk in nine trials because there was either no loss to follow‐up or loss was minimal with reasons for dropout well described and balanced across groups (Behmanesh 2009; Chang 2002; Field 1997; Janssen 2008; Karami 2007; Kimber 2008; Levett 2016; Silva 2013; Taghinejad 2010). We judged five trials to have an unclear risk of bias due to insufficient reporting (Abasi 2009; Bolbol‐Haghighi 2016; Ganji 2013a; Mortazavi 2012; Taavoni 2013).

Selective reporting

We assessed the risk of bias from selective reporting as low in two trials (Kimber 2008; Levett 2016). In both these trials, protocol or student documents were available to the review team to confirm all outcomes were reported. We assessed one trial as having high risk of bias due to denominators not being available (Taavoni 2013). We could not verify reporting bias in 11 trials because there were no protocols available (Abasi 2009; Behmanesh 2009; Bolbol‐Haghighi 2016; Chang 2002; Field 1997; Ganji 2013a; Janssen 2008; Karami 2007; Mortazavi 2012; Silva 2013; Taghinejad 2010).

Other potential sources of bias

We rated the risk of bias from other sources of bias as low in eight trials (Abasi 2009; Chang 2002; Field 1997; Janssen 2008; Karami 2007; Levett 2016; Silva 2013; Taghinejad 2010) due to baseline characteristics being balanced and no other issues being identified. We judged two trials as having high risk of bias due to unclear reporting. Three reports from one trial (Ganji 2013a) specify different exclusion criteria and it is not clear if the results are reported for a subset of a larger trial. We assessed Bolbol‐Haghighi 2016 as having high risk or bias due to there being some baseline imbalances between groups with regard to age and education. We assessed four trials as having unclear risk of bias due to insufficient information (Kimber 2008; Mortazavi 2012; Taavoni 2013). Behmanesh 2009 did not report baseline characteristics.

Effects of interventions

See: Summary of findings for the main comparison Massage compared to usual care for pain management in labour; Summary of findings 2 Warm pack compared to usual care for pain management in labour; Summary of findings 3 Thermal manual methods compared to usual care for pain management in labour; Summary of findings 4 Massage compared to music for pain management in labour

Data from Field 1997 were not in a form that could be included in the meta‐analysis.Three additional outcomes, spontaneous vaginal birth, resuscitation of the newborn, and first degree tear are included in this update of the review. These outcomes were not pre‐specified and were retrospectively included as "other" relevant outcomes to the evaluation of the intervention.

1. Massage versus usual care

We included 10 trials with a total of 795 women in the meta‐analysis. In one trial (Kimber 2008) there were three arms: massage and relaxation, versus placebo and relaxation techniques and music, versus usual care. We disregarded the placebo group from this trial, because this is included in a separate Cochrane review on relaxation techniques; we only included the massage and relaxation versus usual care group arms in this comparison. No trial reported on the following outcomes: satisfaction with pain relief; effect on mother/baby interaction; breastfeeding; poor infant outcomes at long‐term follow up and costs. One trial (Mortazavi 2012), which also included three arms with two control groups, was only reported narratively and so it was not possible to include any data in the analyses.

Primary outcomes

1.1) Pain intensity

The trials reported on the intensity of pain during the three stages of labour (Analysis 1.1). Four trials assessed pain using the Visual Analogue Scale (VAS) (Abasi 2009; Karami 2007; Kimber 2008; Silva 2013); one used the self‐reported pain intensity (PPI) scale (Chang 2002); and one used the McGill Present Pain intensity scale (Janssen 2008). Lower pain scores equated to less pain.

1.1.1) First stage of labour

There was a very small reduction in pain intensity for women receiving massage compared with usual care (standardised mean difference (SMD) −0.81, 95% confidence interval (CI) −1.06 to −0.56; six trials; 362 women; low‐quality evidence).

1.1.2) Second stage of labour

There were no clear differences between groups in pain intensity (SMD −0.98, 95% CI −2.23 to 0.26; two trials; 124 women; there was substantial heterogeneity I2 = 91%; Tau2 = 0.73).

1.1.3) Third stage of labour

There were no clear differences between groups in reduced pain intensity (SMD −1.03, 95% CI −2.17 to 0.11; two trials; 122 women; I2 = 89%; Tau2 = 0.60).

Data from Field 1997 were not in a form that could be added to the forest plots. This study reported less labour pain on a Likert scale for the massage group compared with the control (mean 3.5 versus 5.0).

Mortazavi 2012 reported pain scores graphically and we were unable to extract these data. The authors reported a reduction in pain during all stages of labour in the intervention group.

We conducted a sensitivity analysis in which we excluded the quasi‐RCT (Abasi 2009) from the analysis (data not shown). This made little difference to the overall treatment effect, although statistical heterogeneity as indicated by I2 completely disappeared for the results in the second and third stages of labour.

1.2) Sense of control in labour

Two trials reported outcome but assessed it with different versions of the Labour Agentry Scale. There was an increase in the sense of control during labour (mean difference (MD) 14.05, 95% CI 3.77 to 24.33, one trial, 124 women, low‐quality evidence) using the extended Labour Agentry scale (Levett 2016) (Analysis 1.2).

1.3) Sense of control in labour (shortened Labour Agency Scale)

One small trial (Kimber 2008) used a shortened version of the Labour Agentry Scale, where a lower score is positive and means the woman felt more in control. This trial found an increase in the sense of control in labour in the massage group as indicated by a lower score (MD −6.10, 95% CI −11.68 to −0.52 one trial, 40 women, low‐quality evidence) (Analysis 1.3).

1.4) Satisfaction with childbirth experience (continuous data)

Two trials reported this outcome but measured it in different ways and the data could not be combined. In Chang 2002, there was no clear difference in satisfaction with childbirth experience between groups (MD 0.47, 95% CI −0.13 to 1.07, one trial, 60 women, low‐quality evidence) using an unspecified scale (Analysis 1.4).

1.5) Satisfaction with childbirth experience (dichotomous data)

This question was assessed asking whether labour/birth was: hard work but wonderful; ok in the end; awful; or other, in Kimber 2008. We analysed data on the response "hard work but wonderful". There was a slight increase in satisfaction with childbirth for the massage group compared with the control (risk ratio (RR) 1.90, 95% CI 1.07 to 3.38, one trial, 60 women, very low‐quality evidence) (Analysis 1.5).

1.6) Assisted vaginal birth

There were no clear differences between groups in assisted vaginal birth (average RR 0.71, 95% CI 0.44 to 1.13, four trials, 368 women, very low‐quality evidence) (Analysis 1.6).

1.7) Caesarean section

There were no clear differences between groups in caesarean section rates (RR 0.75, 95% CI 0.51 to 1.09, six trials, 514 women, very low‐quality evidence) (Analysis 1.7).

1.8) Admission to neonatal intensive care unit

There were no clear differences between groups in rates of admission to neonatal intensive care (RR 0.71, 95% CI 0.31 to 1.62, two trials, 231 women) (Analysis 1.8).

1.9) Apgar score less than seven at five minutes

There were no clear differences between groups (RR 0.72, 95% CI 0.17 to 3.14, two trials, 215 women) (Analysis 1.9).

Secondary outcomes

1.10) Use of pharmacological pain relief

There were no clear differences in use of pharmacological pain relief between groups (average RR 0.81, 95% CI 0.37 to 1.74, four trials, 368 women, very low‐quality evidence). There was substantial heterogeneity and we applied a random‐effects model (I2 = 91%; Tau2 = 0. 45) (Analysis 1.10). Heterogeneity was explained by the Levett 2016 trial. Omitting this trial from the meta‐analysis reduced heterogeneity to I2 = 43%. This trial did not involve delivery of the intervention during labour. The intervention was delivered during the antenatal period with time prior to labour to practice the interventions learnt during this period with the aim of managing pain in labour.

1.11) Length of labour

There was no clear difference between groups with the length of labour reported in minutes (MD 20.64, 95% −58.24 to 99.52, six trials, 514 women, very low‐quality evidence). There was significant heterogeneity (I2 = 72%, Tau2 = 6384.7) and we applied a random‐effects model (Analysis 1.11). This heterogeneity is likely explained by the varied length of measurement during differing phases of labour.

In addition, Karami 2007 found reduced length of labour in the first stage of labour for women receiving massage compared with usual care (MD −116.34, 95% −172.68 to −60.00). The Mortazavi 2012 trial reported a duration of labour in the massage group among primiparous women during the active stage of 2.6 hours (standard deviation (SD) 0.95 versus 7.5 hours (SD 1.87) in controls (60% of the women in the massage group delivered in less than 3.5 hours). We did not include this in the meta‐analysis because only duration of "active phase", described as 5 cm to 7 cm dilatation, was reported.

1.12) Need for augmentation with oxytocin

There was no clear evidence of reduced augmentation between groups (average RR 0.77, 95% CI 0.46 to 1.29, five trials, 468 women). There was significant heterogeneity (I2 = 71%; Tau2 = 0.22) and we applied a random‐effects model (Analysis 1.12). No single trial was responsible for the heterogeneity, although heterogeneity was reduced when the trials using oxytocin augmentation were excluded.

1.13) Perineal trauma

There was evidence of reduced perineal trauma in the massage group compared with the control (RR 0.88, 95% CI 0.79 to 0.98, one trial, 128 women) (Analysis 1.13).

1.14) Postpartum haemorrhage

There was no clear evidence of a difference between groups (RR 0.82, 95% CI 0.41 to 1.61, one trial, 171 women) (Analysis 1.14).

1.15) Emotional experience in labour (anxiety)

One trial (Chang 2002) examined women's experience of anxiety during labour. This small trial found less anxiety during the first stage of labour for women receiving massage compared to usual care (MD −16.27, 95% CI −27.03 to −5.51, one trial, 60 women) (Analysis 1.15).

There were no differences between groups during the second stage of labour (MD −8.97, 95% CI −20.79 to 2.85, one trial, 60 women), and third stage of labour (MD −4.57, 95% CI −14.04 to 4.90, one trial, 60 women).

Field 1997 reported improved outcomes for the massage group compared with the control, including less depressed mood (mean 6.9 versus 14.9), and lower stress levels (mean 5.2 versus 3.5).

1.16) Spontaneous vaginal birth (not pre‐specified)

There were no clear differences between groups (average RR 1.12, 95% CI 0.87 to 1.44, four trials, 408 women); there was significant heterogeneity (I2 = 73%; Tau2 = 0.04) and we applied a random‐effects model (Analysis 1.16). The heterogeneity was explained by the Levett 2016. This trial did not involve delivery of the intervention during labour; instead it was delivered during the antenatal period, with time prior to labour to practice the interventions learnt during this period.

1.17) Resuscitation of the newborn (not pre‐specified)

There was evidence of reduced resuscitation of the newborn in the massage group (RR 0.43, 95% CI 0.23 to 0.79, two trials, 231 women) (Analysis 1.17).

2. Warm pack versus usual care

We included three trials with 191 women. In one trial there were four arms (Ganji 2013a), three of which were intervention groups: cold pack, versus intermittent hot and cold packs, versus heat packs only, versus a control of routine care. In this comparison, we have included the heat pack versus usual care arms and we disregarded the other two of the arms of the trial. No trial reported on the following outcomes: sense of control in labour; satisfaction with childbirth experience; satisfaction with pain relief; effect on mother/baby interaction; breastfeeding; assisted vaginal birth; caesarean section rate; side effects on mother/baby; Apgar score less than seven at five minutes; poor infant outcomes at long‐term follow‐up; and costs. One quasi‐randomised trial (Behmanesh 2009) was included in the meta‐analysis.

Primary outcomes

2.1) Pain intensity
2.1.1 First stage of labour

There was a very small reduction in pain intensity from warm packs (SMD −0.59, 95% CI −1.18 to −0.00; 191 women; three trials; I2 = 75%; Tau2 = 0.20; very low‐quality evidence) (Analysis 2.1). Two trials used the VAS scale (Ganji 2013a; Taavoni 2013) and one quasi‐randomised trial used the McGill pain questionnaire (Behmanesh 2009). For all these scales, low scores equated to less pain. Due to high levels of statistical heterogeneity we used a random‐effects model.

2.1.2 Second stage of labour

There was a reduction in pain intensity during the second stage for women receiving warm packs compared with usual care (SMD −1.49, 95% CI −2.85 to −0.13; two trials; 128 women; I2 = 91%; Tau2 = 0.88). Due to high levels of statistical heterogeneity we used a random‐effects model.

We conducted a sensitivity analysis and excluded the quasi‐RCT (Behmanesh 2009) from the analysis (data not shown). The overall result was more precise with the exclusion of this trial and statistical heterogeneity as indicated by I2 completely disappeared (I2 = 0%).

Secondary outcomes

2.2 Length of labour

There was a reduction on the length of labour of over an hour (measured in minutes) for women receiving warm packs versus usual care (MD −66.15, 95% CI −91.83 to −40.47; two trials; 128 women; very low‐quality evidence) (Analysis 2.2).

We conducted a sensitivity analysis and excluded the quasi‐RCT (Behmanesh 2009) from the analysis (data not shown). The overall result was less precise with the exclusion of this trial.

3. Thermal manual methods versus usual care

We included one trial of 96 women (Ganji 2013a). In this trial there were four groups, three of which were intervention groups: cold pack, versus intermittent hot and cold packs, versus heat packs only, versus a control of routine care. In this comparison we have included three arms of the trial and disregarded the heat pack arm, so we have analysed the groups as two comparisons of: 1) cold packs versus usual care; and 2) intermittent hot and cold packs versus usual care. The 'usual care' group has been split between the two comparisons. The following outcomes were not reported: sense of control in labour; satisfaction with childbirth experience; satisfaction with pain relief; use of pharmacological pain relief; effect on mother/baby interaction; breastfeeding; caesarean section rates; side effects on mother/baby; Apgar score less than seven at five minutes; admission to neonatal intensive care; poor infant outcomes at long‐term follow up; and costs.

Primary outcomes

3.1) Pain intensity
3.1.1 Coldpacks versus usual care

There was a reduction in pain intensity measured using the VAS during the first phase of labour for women receiving cold packs (MD −1.43, 95% CI −2.56 to −0.30 one trial, 48 women). Low scores equated to less pain in this scale.

3.1.1.2 Intermittent hot and cold packs versus usual care

There was a reduction in pain intensity measured using the VAS for women receiving intermittent hot and cold packs compared with usual care (MD −1.46, 95% CI −2.59 to −0.33, one trial, 48 women).

Overall, thermal manual methods resulted in a reduction in pain intensity (MD −1.44, 95% CI −2.24 to −0.65; one trial; 96 women; very low‐quality evidence) (Analysis 3.1).

Secondary outcomes

3.2) Assisted vaginal birth
3.2.1 Coldpacks versus usual care

There was no clear evidence of differences between groups with assisted vaginal birth (RR 0.17, 95% CI 0.01 to 3.99, one trial, 48 women).

3.2.2 Intermittent hot and cold packs versus usual care

There was no clear evidence of differences between groups with assisted vaginal birth (RR 1.55, 95% CI 0.07 to 35.94, one trial, 48 women).

Overall, there was no clear difference between groups (RR 0.52, 95% CI 0.08 to 3.54; one trial, 96 women, very low‐quality evidence) (Analysis 3.2)

3.3 Length of labour
3.3.1 Cold packs versus usual care

There was a reduction in the length of labour (reported in minutes) for women who received cold packs compared with usual care (MD −83.47, 95% CI −140.5 to −26.44, one trial, 48 women).

3.3.2 Intermittent hot and cold packs versus usual care

There was a reduction in the length of labour (reported in minutes) for women who received intermittent hot and cold packs compared with usual care (MD −72.91, 95% CI −130.40 to −15.36, one trial, 48 women).

Overall, there was a reduction in length of labour for the women who received thermal manual methods (MD −78.24, 95% CI −118.75 to −37.73; one trial, 96 women, very low‐quality evidence) (Analysis 3.3).

3.4 Need for augmentation with oxytocin
3.4.1 Cold packs versus usual care

There was no clear evidence of differences between groups for augmentation rates (RR 1.00, 95% CI 0.55 to 1.82, one trial, 48 women).

3.4.2 Intermittent hot and cold packs versus usual care

There was no clear evidence of differences between groups for augmentation of labour (RR 0.89, 95% CI 0.51 to 1.55, one trial, 48 women).

Overall, there was no clear difference in augmentation rates between the groups (RR 0.94, 95% CI 0.63 to 1.41; one trial, 96 women) (Analysis 3.4).

3.5 Episiotomy
3.5.1 Cold packs versus usual care

There was no clear evidence of a difference between groups in episiotomy rates (RR 0.90, 95% CI 0.74 to 1.09, one trial, 48 women).

3.5.2 Intermittent hot and cold packs versus usual care

There was no clear evidence of a difference between groups in episiotomy (RR 1.03, 95% CI 0.9 to 1.19, one trial, 48 women).

Overall, there was no clear evidence of a difference between groups in episiotomy (RR 0.97, 95% CI 0.86 to 1.09; one trial, 96 women) (Analysis 3.5).

3.6 First degree tear (not pre‐specified)
3.6.1 Cold packs versus usual care

There was no clear evidence of a difference between groups (RR 2.50, 95% CI 0.32 to 19.64, one trial, 48 women).

3.6.2 Intermittent hot and cold packs versus usual care

There was no clear evidence of a difference between groups (RR 0.50, 95% CI 0.03 to 7.49, one trial, 48 women).

Overall, there was no clear evidence of a difference between groups (RR 1.50, 95% CI 0.32 to 7.02, one trial, 96 women) (Analysis 3.6).

4. Massage versus music

We included one trial with 101 women. None of the following outcomes were reported: sense of control in labour; satisfaction with childbirth experience; satisfaction with pain relief; effect on mother/baby interaction; breastfeeding; assisted vaginal birth; caesarean section rates; augmentation; admission to neonatal intensive care; side effects on mother/baby; Apgar score less than seven at five minutes; poor infant outcomes at long‐term follow up; and costs.

Primary outcomes

4.1) Pain intensity

The Taghinejad 2010 trial assessed this outcome using the VAS as a categorical variable and we reported on women with the most severe categories of pain. This trial found pain was reduced in the massage group versus music group (RR 0.40, 95% CI 0.18 to 0.89, one trial, 101 women, very low‐quality evidence) (Analysis 4.1). Data on pain intensity were also reported as a median and interquartile range. The trial found evidence for benefit from massage with a reduction in the intensity of pain to 3.47 ± 0.879 compared with 4.1 ± 1.05 in the music group (P = 009).

Secondary outcomes

4.2) Use of pharmacological pain relief

There were no differences in the use of pharmacological pain relief in the massage group compared with music (RR 0.41, 95% CI 0.16 to 1.08, one trial, 101 women, very low‐quality evidence) (Analysis 4.2).

Other comparisons

We found no trials which compared massage with other control interventions including hypnosis, biofeedback, intracutaneous or subcutaneous sterile water injection, immersion in water, aromatherapy, relaxation, and acupuncture or acupressure.

Subgroup analysis

We did not undertake subgroup analysis, based on insufficient reporting of trials with the variables of interest by outcome.

Discussion

Summary of main results

We included 14 trials, 10 of which (1055 women) were included in the meta‐analyses. Our analyses suggested a limited benefit from massage in relation to the primary outcome of pain intensity, sense of control in labour, satisfaction with childbirth, emotional experience during labour. Compared with usual care, massage was associated with reduced pain during the first stage of labour (very low‐quality evidence), while its effect during the second and third phases of labour was not clear (low‐quality evidence). Effects of massage versus usual care on assisted vaginal birth and caesarean delivery were unclear (very low‐quality evidence). There was no clear benefit on the length of labour and use of pharmacological pain relief (very low‐quality evidence). Compared with music, there was evidence of a small benefit from massage in relation to reduced pain (low‐quality evidence), but no clear benefit in relation to reduced pharmacological pain relief (very low‐quality evidence). Warm packs were associated with reduced pain in the first stage of labour and reduced length of labour (very low‐quality evidence).

Currently there are only small numbers of trials included within each comparison. This limits the power of the review to detect meaningful differences between groups and analyses, therefore the limited benefits we found should be interpreted with caution.

Overall completeness and applicability of evidence

We found few trials on manual methods for management of labour pain, and these were mostly limited to trials of massage. The completeness and applicability of the evidence is limited by the small number of included trials. We identified the majority of trials as having a high risk of bias for at least one domain. One trial had a low risk of bias for all domains except for performance bias, which was unclear due to lack of blinding (Levett 2016). The majority of trials only included a limited number of relevant outcomes and failed to collect safety outcomes. Trials recruited both nulliparous and multiparous women at term, with the interventions administered in the labour ward environment. Trials were conducted in different countries, and this may reflect the use of particular modalities or techniques as part of the local culture. The systematic review illustrates variation in how these modalities were practiced, although it is unclear how generalisable the treatment protocols used in the research are to clinical practice or practice within the community.

Quality of the evidence

The risk of bias table (Figure 2, Figure 3) demonstrates massage has not been subject to consistent rigorous evaluation. The quality of reporting was poor in the majority of trials. Consequently, it is difficult to assess the overall risk of bias across trials and domains. For many trials, blinding of participants and the practitioner was not possible. Reporting indicated that some outcomes may have been influenced by a lack of blinding by the outcome assessor and consequently were rated at a high risk of bias. For self‐reported outcomes we acknowledge that lack of blinding may impact on the pain intensity scores, however objective outcome measures — for example mode of birth — are less likely to be altered by detection bias. The small number of trials within comparisons, and the lack of high‐quality trials, indicates there is currently insufficient evidence of a consistent treatment effect from massage trials included in the review. Three quasi‐randomised trial were excluded from the meta‐analysis. The chief investigators of some trials were contacted to provide additional methodological and statistical information; however, only a few responses were obtained (Abasi 2009; Field 1997; Karami 2007).

The quality of evidence, using GRADE criteria, was low to very low for all outcomes (summary of findings Table for the main comparison; summary of findings Table 2; summary of findings Table 3; summary of findings Table 4). We downgraded the quality of evidence due to severe unexplained heterogeneity in some comparisons, indirectness of interventions, wide confidence intervals, and small samples sizes with few events.

Potential biases in the review process

We attempted to minimise bias during the review process. Two authors assessed the eligibility of trials, carried out data extraction and assessed the risk of bias. We are aware that some literature on relaxation therapies may not be published in mainstream journals and therefore may be excluded from the main databases. Our search was comprehensive, but we cannot rule out the possibility that some trials may have been missed.

Agreements and disagreements with other studies or reviews

Due to the lack of research examining the effect of massage on pain management in labour, we are limited in our ability to make comparisons with other trials and reviews. The included trials are based on one or a combination of the theoretical framework working with pain or effective pain relief. There are few trials reporting on a range of outcomes relating to pain management or working with pain. The comparison of massage with usual care provides some low‐quality evidence of a relationship between reduced pain in labour with a sense of control in labour but not overall higher satisfaction with labour. This supports findings from other trials examining the relationship between pain and childbirth satisfaction more broadly (Waldenstrom 1999; Windridge 1999).

Trial flow diagram.
Figures and Tables -
Figure 1

Trial flow diagram.

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included trials.
Figures and Tables -
Figure 2

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included trials.

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.
Figures and Tables -
Figure 3

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.

Comparison 1 Massage versus usual care, Outcome 1 Pain intensity.
Figures and Tables -
Analysis 1.1

Comparison 1 Massage versus usual care, Outcome 1 Pain intensity.

Comparison 1 Massage versus usual care, Outcome 2 Sense of control in labour.
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Analysis 1.2

Comparison 1 Massage versus usual care, Outcome 2 Sense of control in labour.

Comparison 1 Massage versus usual care, Outcome 3 Sense of control in labour (shortened Labour Agentry Scale).
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Analysis 1.3

Comparison 1 Massage versus usual care, Outcome 3 Sense of control in labour (shortened Labour Agentry Scale).

Comparison 1 Massage versus usual care, Outcome 4 Satisfaction with childbirth experience.
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Analysis 1.4

Comparison 1 Massage versus usual care, Outcome 4 Satisfaction with childbirth experience.

Comparison 1 Massage versus usual care, Outcome 5 Satisfaction with childbirth experience.
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Analysis 1.5

Comparison 1 Massage versus usual care, Outcome 5 Satisfaction with childbirth experience.

Comparison 1 Massage versus usual care, Outcome 6 Assisted vaginal birth.
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Analysis 1.6

Comparison 1 Massage versus usual care, Outcome 6 Assisted vaginal birth.

Comparison 1 Massage versus usual care, Outcome 7 Caesarean section.
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Analysis 1.7

Comparison 1 Massage versus usual care, Outcome 7 Caesarean section.

Comparison 1 Massage versus usual care, Outcome 8 Admission to neonatal intensive care unit.
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Analysis 1.8

Comparison 1 Massage versus usual care, Outcome 8 Admission to neonatal intensive care unit.

Comparison 1 Massage versus usual care, Outcome 9 Apgar score < 7 at 5 mins.
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Analysis 1.9

Comparison 1 Massage versus usual care, Outcome 9 Apgar score < 7 at 5 mins.

Comparison 1 Massage versus usual care, Outcome 10 Use of pharmacological pain relief.
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Analysis 1.10

Comparison 1 Massage versus usual care, Outcome 10 Use of pharmacological pain relief.

Comparison 1 Massage versus usual care, Outcome 11 Length of labour (minutes).
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Analysis 1.11

Comparison 1 Massage versus usual care, Outcome 11 Length of labour (minutes).

Comparison 1 Massage versus usual care, Outcome 12 Need for augmentation with oxytocin.
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Analysis 1.12

Comparison 1 Massage versus usual care, Outcome 12 Need for augmentation with oxytocin.

Comparison 1 Massage versus usual care, Outcome 13 Perineal trauma.
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Analysis 1.13

Comparison 1 Massage versus usual care, Outcome 13 Perineal trauma.

Comparison 1 Massage versus usual care, Outcome 14 Postpartum haemorrhage.
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Analysis 1.14

Comparison 1 Massage versus usual care, Outcome 14 Postpartum haemorrhage.

Comparison 1 Massage versus usual care, Outcome 15 Women's emotional experience of the intervention (reduced anxiety) in labour.
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Analysis 1.15

Comparison 1 Massage versus usual care, Outcome 15 Women's emotional experience of the intervention (reduced anxiety) in labour.

Comparison 1 Massage versus usual care, Outcome 16 Spontaneous vaginal birth (not pre‐specified).
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Analysis 1.16

Comparison 1 Massage versus usual care, Outcome 16 Spontaneous vaginal birth (not pre‐specified).

Comparison 1 Massage versus usual care, Outcome 17 Resuscitation of newborn (not pre‐specified).
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Analysis 1.17

Comparison 1 Massage versus usual care, Outcome 17 Resuscitation of newborn (not pre‐specified).

Comparison 2 Warm pack versus usual care, Outcome 1 Pain intensity.
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Analysis 2.1

Comparison 2 Warm pack versus usual care, Outcome 1 Pain intensity.

Comparison 2 Warm pack versus usual care, Outcome 2 Length of labour (minutes).
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Analysis 2.2

Comparison 2 Warm pack versus usual care, Outcome 2 Length of labour (minutes).

Comparison 3 Thermal manual methods versus usual care, Outcome 1 Pain intensity.
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Analysis 3.1

Comparison 3 Thermal manual methods versus usual care, Outcome 1 Pain intensity.

Comparison 3 Thermal manual methods versus usual care, Outcome 2 Assisted vaginal birth.
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Analysis 3.2

Comparison 3 Thermal manual methods versus usual care, Outcome 2 Assisted vaginal birth.

Comparison 3 Thermal manual methods versus usual care, Outcome 3 Length of labour (minutes).
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Analysis 3.3

Comparison 3 Thermal manual methods versus usual care, Outcome 3 Length of labour (minutes).

Comparison 3 Thermal manual methods versus usual care, Outcome 4 Need for augmentation with oxytocin.
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Analysis 3.4

Comparison 3 Thermal manual methods versus usual care, Outcome 4 Need for augmentation with oxytocin.

Comparison 3 Thermal manual methods versus usual care, Outcome 5 Episiotomy.
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Analysis 3.5

Comparison 3 Thermal manual methods versus usual care, Outcome 5 Episiotomy.

Comparison 3 Thermal manual methods versus usual care, Outcome 6 First degree tear (not pre‐specified).
Figures and Tables -
Analysis 3.6

Comparison 3 Thermal manual methods versus usual care, Outcome 6 First degree tear (not pre‐specified).

Comparison 4 Massage versus music, Outcome 1 Pain intensity.
Figures and Tables -
Analysis 4.1

Comparison 4 Massage versus music, Outcome 1 Pain intensity.

Comparison 4 Massage versus music, Outcome 2 Use of pharmacological pain relief.
Figures and Tables -
Analysis 4.2

Comparison 4 Massage versus music, Outcome 2 Use of pharmacological pain relief.

Summary of findings for the main comparison. Massage compared to usual care for pain management in labour

Massage compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital settings in Australia, Brazil, Canada, Iran, Taiwan, UK
Intervention: massage
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
( )

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with massage

Pain intensity — first stage of labour

The mean pain score in the massage group was 0.81 standard deviations lower
(1.06 lower to 0.56 lower)

362
(6 RCTs)

⊕⊕⊝⊝
LOW 1 2

Lower pain scores = less pain

Sense of control in labour

Seven point scale, 29 items range ‘1=almost always’, to ‘7=rarely’

The mean sense of control in labour was 150.92

MD 14.05 higher
(3.77 higher to 24.33 higher)

124
(1 RCT)

⊕⊕⊝⊝3
LOW

High score more control

Sense of control in labour (shortened Labour Agentry Scale).

Seven point scale range ‘1=almost always’, to ‘7=rarely’

The mean sense of control in labour (shortened Labour Agentry Scale) was 33.6

MD 6.1 lower
(11.68 lower to 0.52 lower)

56
(1 RCT)

⊕⊕⊝⊝
LOW 2 4

Low score more positive

Satisfaction with childbirth experience.

Five point scale, 5=more satisfaction

The mean satisfaction with childbirth experience was 3.7

MD 0.47 higher
(0.13 lower to 1.07 higher)

60
(1 RCT)

⊕⊝⊝⊝
VERY LOW 2 5

Higher score indicates greater satisfaction

Satisfaction with childbirth experience

Study population

RR 1.90
(1.07 to 3.38)

60
(1 RCT)

⊕⊕⊝⊝
LOW 2 4

333 per 1000

633 per 1000
(357 to 1000)

Assisted vaginal birth

Study population

RR 0.71
(0.44 to 1.13)

368
(4 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

191 per 1000

136 per 1000
(84 to 216)

Caesarean section

Study population

RR 0.75
(0.51 to 1.09)

514
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

191 per 1000

144 per 1000
(98 to 209)

Use of pharmacological pain relief

Study population

RR 0.81
(0.37 to 1.74)

368
(4 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6

568 per 1000

460 per 1000
(210 to 989)

Length of labour (minutes)

The mean length of labour was 547.25 minutes

MD 20.64 minutes higher
(58.24 lower to 99.52 higher)

514
(6 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 6 7

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level due to massage being given for the first time during the trial by untrained personnel (indirectness).

2 Downgraded one level due to design limitations being present in most trials.

3 Downgraded two levels due to a single study with a small sample size.

4 Downgraded one level due to small sample size.

5 Downgraded two levels due to small sample size and wide confidence intervals that cross the line of no effect.

6 Downgraded one level due to wide confidence intervals that cross the line of no effect.

7 Downgraded one level due to high statistical heterogeneity.

Figures and Tables -
Summary of findings for the main comparison. Massage compared to usual care for pain management in labour
Summary of findings 2. Warm pack compared to usual care for pain management in labour

Warm pack compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital settings in Iran
Intervention: warm pack
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with warm pack

Pain intensity — first stage of labour

The mean pain score in the warm pack group was 0.59 standard deviations lower (1.18 lower to 0.00)

191
(3 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 3

Low scores = less pain

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth — not reported

Caesarean section — not reported

Use of pharmacological pain relief — not reported

Length of labour: minutes

The mean length of labour was 246.88 minutes

MD 66.15 minutes lower
(91.83 lower to 40.47 lower)

128
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 4 5

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded two levels due to serious design limitations in two trials contributing 66.9% weight to final analysis. One other trial with design limitations.

2 Downgraded two levels due to small sample size and wide confidence intervals just touching the line of no effect.

3 Downgraded one level due to high statistical heterogeneity.

4 Downgraded two levels due to one trial with serious design limitations contributing 68.4% weight to final analysis. One other trial with design limitations.

5 Downgraded one level due to small sample size.

Figures and Tables -
Summary of findings 2. Warm pack compared to usual care for pain management in labour
Summary of findings 3. Thermal manual methods compared to usual care for pain management in labour

Thermal manual methods compared to usual care for pain management in labour

Patient or population: women in labour
Setting: hospital in Iran
Intervention: thermal manual methods
Comparison: usual care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with usual care

Risk with thermal manual methods

Pain intensity ‐ first stage of labour

The mean pain intensity was 6.9

MD 1.44 lower
(2.24 lower to 0.65 lower)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

Low score = less pain

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth

Study population

RR 0.52
(0.08 to 3.54)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 3

31 per 1000

16 per 1000
(3 to 111)

Caesarean section — not reported

Use of pharmacological pain relief — not reported

Length of labour: minutes

The mean length of labour was 273 minutes

MD 78.24 minutes lower
(118.75 lower to 37.73 lower)

96
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded two levels due serious design limitations in one trial contributing data.

2 Downgraded one level due to small sample size.

3 Downgraded two levels due to small sample size, few events and wide confidence intervals that cross the line of no effect.

Figures and Tables -
Summary of findings 3. Thermal manual methods compared to usual care for pain management in labour
Summary of findings 4. Massage compared to music for pain management in labour

Massage compared to music for pain management in labour

Patient or population: women in labour
Setting: hospital in Iran
Intervention: Massage
Comparison: music

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with music

Risk with massage

Pain intensity "severe pain reported"

Study population

RR 0.40
(0.18 to 0.89)

101
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 2

340 per 1000

136 per 1000
(61 to 303)

Sense of control in labour — not reported

Satisfaction with childbirth experience — not reported

Assisted vaginal birth — not reported

Caesarean section — not reported

Use of pharmacological pain relief

Study population

RR 0.41
(0.16 to 1.08)

101
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1 3

240 per 1000

98 per 1000
(38 to 259)

Length of labour — not reported

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 Downgraded one level for design limitations in one trial contributing data.

2 Downgraded two levels for small sample size and few events.

3 Downgraded two levels for small sample size, few events, and wide confidence intervals just crossing the line of no effect.

Figures and Tables -
Summary of findings 4. Massage compared to music for pain management in labour
Comparison 1. Massage versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 First stage of labour

6

362

Std. Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.06, ‐0.56]

1.2 Second stage of labour

2

124

Std. Mean Difference (IV, Random, 95% CI)

‐0.98 [‐2.23, 0.26]

1.3 Third stage of labour

2

122

Std. Mean Difference (IV, Random, 95% CI)

‐1.03 [‐2.17, 0.11]

2 Sense of control in labour Show forest plot

1

124

Mean Difference (IV, Fixed, 95% CI)

14.05 [3.77, 24.33]

3 Sense of control in labour (shortened Labour Agentry Scale) Show forest plot

1

56

Mean Difference (IV, Fixed, 95% CI)

‐6.10 [‐11.68, ‐0.52]

4 Satisfaction with childbirth experience Show forest plot

1

60

Mean Difference (IV, Random, 95% CI)

0.47 [‐0.13, 1.07]

5 Satisfaction with childbirth experience Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

1.9 [1.07, 3.38]

6 Assisted vaginal birth Show forest plot

4

368

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.44, 1.13]

7 Caesarean section Show forest plot

6

514

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.51, 1.09]

8 Admission to neonatal intensive care unit Show forest plot

2

231

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.31, 1.62]

9 Apgar score < 7 at 5 mins Show forest plot

2

215

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.17, 3.14]

10 Use of pharmacological pain relief Show forest plot

4

368

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.37, 1.74]

11 Length of labour (minutes) Show forest plot

6

514

Mean Difference (IV, Random, 95% CI)

20.64 [‐58.24, 99.52]

12 Need for augmentation with oxytocin Show forest plot

5

468

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.46, 1.29]

13 Perineal trauma Show forest plot

1

128

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.79, 0.98]

14 Postpartum haemorrhage Show forest plot

1

171

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.41, 1.61]

15 Women's emotional experience of the intervention (reduced anxiety) in labour Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

15.1 Anxiety first stage

1

60

Mean Difference (IV, Fixed, 95% CI)

‐16.27 [‐27.03, ‐5.51]

15.2 Anxiety second stage

1

60

Mean Difference (IV, Fixed, 95% CI)

‐8.97 [‐20.79, 2.85]

15.3 Anxiety third stage

1

60

Mean Difference (IV, Fixed, 95% CI)

‐4.57 [‐14.04, 4.90]

16 Spontaneous vaginal birth (not pre‐specified) Show forest plot

4

408

Risk Ratio (M‐H, Random, 95% CI)

1.12 [0.87, 1.44]

17 Resuscitation of newborn (not pre‐specified) Show forest plot

2

231

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.23, 0.79]

Figures and Tables -
Comparison 1. Massage versus usual care
Comparison 2. Warm pack versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity Show forest plot

3

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 First stage of labour

3

191

Std. Mean Difference (IV, Random, 95% CI)

‐0.59 [‐1.18, ‐0.00]

1.2 Second stage of labour

2

128

Std. Mean Difference (IV, Random, 95% CI)

‐1.49 [‐2.85, ‐0.13]

2 Length of labour (minutes) Show forest plot

2

128

Mean Difference (IV, Fixed, 95% CI)

‐66.15 [‐91.83, ‐40.47]

Figures and Tables -
Comparison 2. Warm pack versus usual care
Comparison 3. Thermal manual methods versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity Show forest plot

1

96

Mean Difference (IV, Fixed, 95% CI)

‐1.44 [‐2.24, ‐0.65]

1.1 Cold packs versus usual care

1

48

Mean Difference (IV, Fixed, 95% CI)

‐1.43 [‐2.56, ‐0.30]

1.2 Intermittent hot and cold packs versus usual care

1

48

Mean Difference (IV, Fixed, 95% CI)

‐1.46 [‐2.59, ‐0.33]

2 Assisted vaginal birth Show forest plot

1

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.08, 3.54]

2.1 Cold packs versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.17 [0.01, 3.99]

2.2 Intermittent hot and cold pack versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [0.07, 35.94]

3 Length of labour (minutes) Show forest plot

1

96

Mean Difference (IV, Fixed, 95% CI)

‐78.24 [‐118.75, ‐37.73]

3.1 Cold packs versus usual care

1

48

Mean Difference (IV, Fixed, 95% CI)

‐83.47 [‐140.50, ‐26.44]

3.2 Intermittent hot and cold packs versus usual care

1

48

Mean Difference (IV, Fixed, 95% CI)

‐72.91 [‐130.46, ‐15.36]

4 Need for augmentation with oxytocin Show forest plot

1

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.63, 1.41]

4.1 Cold packs versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.55, 1.82]

4.2 Intermittent hot and cold pack versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.89 [0.51, 1.55]

5 Episiotomy Show forest plot

1

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.86, 1.09]

5.1 Cold packs versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.9 [0.74, 1.09]

5.2 Intermittent hot and cold pack versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.90, 1.19]

6 First degree tear (not pre‐specified) Show forest plot

1

96

Risk Ratio (M‐H, Fixed, 95% CI)

1.5 [0.32, 7.02]

6.1 Cold packs versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

2.5 [0.32, 19.64]

6.2 Intermittent hot and cold pack versus usual care

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.03, 7.49]

Figures and Tables -
Comparison 3. Thermal manual methods versus usual care
Comparison 4. Massage versus music

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain intensity Show forest plot

1

101

Risk Ratio (M‐H, Fixed, 95% CI)

0.40 [0.18, 0.89]

2 Use of pharmacological pain relief Show forest plot

1

101

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.16, 1.08]

Figures and Tables -
Comparison 4. Massage versus music