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DOI: 10.1111/1471-0528.

12320 General obstetrics


www.bjog.org

Hypnosis Antenatal Training for Childbirth:


a randomised controlled trial
AM Cyna,a,b CA Crowther,c,d JS Robinson,c MI Andrew,a G Antoniou,e P Baghurste
a
Department of Women’s Anaesthesia, Women’s & Children’s Hospital, North Adelaide, Australia b Acute Care Medicine, University of
Adelaide, Adelaide, Australia c Obstetrics and Gynaecology, University of Adelaide, Adelaide, Australia d The Liggins Institute, University of
Auckland, Auckland, New Zealand e Public Health Research Unit, Women’s and Children’s Hospital, North Adelaide, Australia
Correspondence: Dr AM Cyna, Department of Women’s Anaesthesia, Women’s & Children’s Hospital, 72 King William Road, Adelaide,
SA 5006, Australia. Email allan.cyna@health.sa.gov.au

Accepted 19 April 2013. Published Online 3 July 2013.

Objective To determine the use of pharmacologic analgesia during antenatal hypnosis CDs as group 1, but did not receive live
childbirth when antenatal hypnosis is added to standard care. hypnosis training. The control group participants were given no
additional intervention or CDs.
Design Randomised controlled clinical trial, conducted from
December 2005 to December 2010. Main outcome measure Use of pharmacological analgesia during
labour and childbirth.
Setting The largest tertiary referral centre for maternity care in
South Australia. Results No difference in the use of pharmacological analgesia
during labour and childbirth was found comparing
Population A cohort of 448 women at >34 weeks of gestation,
hypnosis + CD with control (81.2 versus 76.2%; relative risk, RR
with a singleton pregnancy and cephalic presentation, planning a
1.07; 95% confidence interval, 95% CI 0.95–1.20), or comparing
vaginal birth. Exclusions were: the need for an interpreter; pre-
CD only with control (76.9 versus 76.2%, RR 1.01, 95% CI 0.89–
existing pain; psychiatric illness; younger than 18 years; and
1.15).
previous experience of hypnosis for childbirth.
Conclusions Antenatal group hypnosis using the Hypnosis
Methods All participants received usual care. The group of
Antenatal Training for Childbirth (HATCh) intervention in late
women termed Hypnosis + CD (hypnotherapist guided) were
pregnancy does not reduce the use of pharmacological analgesia
offered three antenatal live hypnosis sessions plus each session’s
during labour and childbirth.
corresponding audio CD for further practise, as well as a final
fourth CD to listen to during labour. The group of women Keywords Analgesia, childbirth, communication, hypnosis,
termed CD only (nurse administered) were played the same labour, psychological responses.

Please cite this paper as: Cyna A, Crowther C, Robinson J, Andrew M, Antoniou G, Baghurst P. Hypnosis Antenatal Training for Childbirth: a randomised
controlled trial. BJOG 2013;120:1248–1259.

negative myths associated with hypnosis have led to a


Introduction
decline in its use.8 However, since the 1950s there has been
Hypnosis is difficult to define,1 but appears to be a day- renewed interest after hypnosis was formally recognised by
dream-like, conscious state of focused attention that can the British Medical Association (BMA) Working Party as
result in a reduced awareness of external stimuli, and an an effective clinical tool.9 More recently, positron emission
increased response to suggestion.2,3 Suggestions are verbal tomography or functional magnetic resonance imaging
or non-verbal communications that lead to apparent non- have shown the consistent finding of anterior cingulate
volitional changes in patient perception or behaviour, and modulation when hypnosis is used to induce analgesia.10–12
are pivotal in eliciting hypnotic responses.4,5 Perceptions of the increased medicalisation of childbirth
Pain relief during childbirth has been a primary target of have led many women to look for alternative means of
clinical hypnosis for more than a century.6 Anaesthesia and relieving pain during labour.13,14 Hypnosis, despite being
clinical hypnosis have had a long association.7 The intro- used for some remarkable cases of painless surgery,15,16 has
duction of chemical analgesia in the 19th century and not been considered to be a reliable method of labour

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analgesia.17 Systematic reviews of randomised controlled participants in the hypnosis + CD and CD-only groups
trials (RCTs) investigating the effects of hypnosis during were provided with a CD on hypnosis designed for each
childbirth have suggested that hypnosis decreases analgesia session. The HATCh intervention was administered in a
requirements during labour, decreases the use of oxytocic group setting, with attendance over three consecutive
labour augmentation, and increases the incidence of vaginal weekly sessions, and participants were asked to practise on
birth.14,18,19 This evidence has come from small or poorly a daily basis at home using the relevant CD. At the third
designed trials,20–24 which were inadequate to confirm these antenatal session, participants allocated to the hypno-
apparent benefits.25,26 Antenatal hypnosis training of sis + CD and CD-only groups were provided with CDs 3
women in the first and second trimester of pregnancy was and 4 and asked to use the fourth CD in labour. Control
found to reduce analgesia use during childbirth, and fur- group participants continued with their usual preparation
ther study in late pregnancy was advocated.24 We investi- for childbirth, such as antenatal classes and clinic appoint-
gated whether standardised group hypnosis training in late ments, with no additional intervention.25 Participants
pregnancy reduced analgesia requirements during child- unable to attend an allocated session in person were
birth.25 contacted by telephone, and the relevant CD was posted
for them to listen to prior to their next session. All partici-
pants received usual care and follow-up, regardless of
Methods
group allocation. Participants assigned to hypnosis groups
The Hypnosis Antenatal Training for Childbirth (HATCh) commenced hypnosis training as near as possible to
trial was an RCT using a three-arm parallel group design, 37 weeks of gestation. Treatment allocations were
with a 1:1:1 ratio. It was conducted in the largest tertiary concealed from the treating obstetricians, anaesthetists,
referral centre for maternity care in South Australia, between midwives, and personnel who were collecting the data. Our
December 2005 and December 2010. Women between 34+0 primary outcome, the use of pharmacological analgesia
and 39+0 weeks of gestation, who were planning a vaginal during labour and childbirth was defined as using one or
birth, were not in active labour, and were carrying a single- more analgesia techniques, such as: inhaled nitrous oxide
ton, viable fetus of vertex presentation were eligible for inclu- in oxygen (EntonoxTM); a parenteral opioid such as intra-
sion. Exclusion criteria were: previous hypnosis preparation muscular Pethidine; and/or epidural analgesia, such as
for childbirth; poor understanding of English, requiring a 0.2% Ropivacaine with fentanyl, 2 mg/ml. The attending
translator; current enrolment in another pregnancy trial in midwife documented all analgesia use and mode of delivery
which analgesia requirements were an outcome measure; on the birth register. A researcher, blinded to treatment
active psychological or psychiatric problems; and severe allocation, managed data collection from medical and nurs-
intellectual disability. Women with previous hypnosis child- ing records on the ward from postnatal questionnaires after
birth training or with pre-existing pain were also excluded. the birth, and then at 6 weeks follow-up, as detailed previ-
Following trial registration (ACTRN012605000018617, 18 ously.25 In addition, At 6 months follow–up we asked
July 2005; NCT00282204, 24 January 2006), and approval women about treatment for depression since the birth.
from the Women’s and Children’s Hospital Human
Research Ethics Committee in 2004 and subsequently Development of the structured intervention
extended by the Child Youth and Women’s Health Service delivered by CD on hypnosis
(CYWHS) Human Research Ethics Committee (REC 1600/ The HATCh intervention was based on published scripts of
12/09), informed written patient consent was obtained suggestions, by experts in the administration of hypnosis
from eligible women agreeing to participate. After baseline for childbirth,27,28 combined with our own clinical experi-
demographic testing was completed, study participants ence. HATCh intervention scripts were used to produce
were stratified for parity and randomised in (unspecified) three CDs that mirrored our hypnosis preparation for
blocks of 15 by a computer random number generator. childbirth, with each CD lasting between 21 and 32 min-
Allocation concealment was assured by using a computer utes.29,30 A fourth CD lasting 18 minutes was also devel-
database assignment to one of three groups, which was oped for use during labour and childbirth.29 Women in the
only revealed after patient identifiers had been entered. hypnosis + CD group were guided in to a state of hypnosis
Participants in the hypnosis + CD group received ante- using the preferred induction method of the hypnothera-
natal hypnosis training from a doctor qualified in hypnosis pist: usually an eye fixation technique or Spiegel.31,32
and were given a CD on hypnosis after each session to
supplement the intervention. Participants in the CD-only Power calculation
group received the HATCh intervention by listening to the An audit of 100 consecutive mothers birthing at our insti-
relevant CD for each session, administered by a nurse with tution in May 2004 showed an incidence of using one or
no training in hypnotherapy. After each session, more pharmacological interventions of 80%. In order to

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show a clinically relevant difference of 20% in the number analyses, and reported upon if there were any significant
of women requiring pharmacological analgesia, we used a differences to unadjusted data.
two-tailed calculation (NQUERY ADVISOR 5.0; Statistical Solu- Preplanned subgroup analyses of primary outcomes were
tions Ltd., Cork, Ireland). A study power of 80% would performed for women regarding: induced versus spontane-
require each group to contain 135 women to detect this ous labour; attendance at all three sessions, whether each
difference at the 0.05 level. We planned to recruit 150 session CD was used at least once; women’s hypnotisability,
women per group, as we estimated that 10% of participants as measured by the CIS; women’s beliefs of the efficacy of
would deliver prior to receiving their allocated treatment. hypnosis prior to labour; women’s expectations of requir-
Following baseline demographic data collection, which ing an epidural; women’s expectations of having a normal
included the administration of the Edinburgh Postnatal spontaneous birth; and previous use of yoga. Descriptive
Depression Scale (EPDS),33 Spielberger State–Trait Anxiety statistics are presented as mean, standard deviation (SD)
Inventory,34 and Creative Imagination Scale (CIS),35 trial for normally distributed data, median and interquartile
participants were informed of where and when to attend (IQR) range for skewed data, and proportions for dichoto-
their allocated sessions. mous outcomes. Likelihood ratio chi-square statistics and
relative risks (RRs) with 95% confidence intervals (95%
Baseline measures CIs) or odds ratios (ORs) have been used. Differences at
The Spielberger State–Trait Anxiety Inventory involves the level of P < 0.05 were considered to be significant. For
asking participants to score 20 statements on a four-point ease of interpretation, relative risks were estimated wher-
Likert scale, indicating the frequency with which they ever possible using binomial models with a log-link. In
have felt a certain emotion over the previous 7 days. subgroup analyses where models with the log link failed to
Scores > 44 have been classed as indicating a state of high converge, odds ratios were estimated using a binomial
anxiety.36,37 model with a logit link.
The EPDS consists of ten statements that evaluate how
an individual has felt over the previous 7 days.33 The EPDS
Results
has been recommended for routine use to identify women
at risk for postnatal depression,38 and a score > 12 is The eligibility of 776 women for trial entry was assessed
widely used to indicate a probable depressive disorder.39 between December 2005 and July 2009, and 448 women
Study participants were left undisturbed to measure their were found to be eligible and were included in the study
baseline hypnotisability by listening to a CD of the CIS.35 (Figure 1). At 6 weeks postpartum, 400 women (89.3%)
This scale is self-appraising, and the maximum score is 40. returned questionnaires with data suitable for analyses. Our
The CIS scale CD was made in-house from published baseline data shows that the randomisation with stratifica-
scripts,35 and contained ten scenarios that encourage test tion for parity produced comparable groups (Table 1).
subjects to use their imagination to create suggested effects,
such as arm heaviness, age regression, and time distortion. Compliance with treatment allocation and
Each scenario is ranked by the participant on a five-point scheduling
Likert scale to score their experience: 0, 0%; 1, 25%; 2, The attendance of HATCh trial participants according to
50%; 3, 75%; 4, 90%. their allocated group and self-reported compliance with
listening to the CD on at least one occasion is shown
Data management/analyses according to their allocated group (Table S1). Less than
After completing nearly 2 years of recruitment, we became 50% of women allocated to an intervention attended all
aware that some women, who were ineligible for participa- three allocated hypnosis sessions, and even fewer attended
tion, had been inadvertently randomised, outside our eligi- the CD sessions. Hypnosis training undertaken outside the
bility criteria, prior to 34 weeks of gestation. We therefore trial was reported by 17 HATCh trial participants (3.9%):
continued to recruit women until our initial planned sam- two allocated to the hypnosis group (1.3%), seven allocated
ple size of eligible women had been reached. Only women to the CD only group (5.0%), and eight allocated to the
who met all eligibility criteria for inclusion were analysed control group (5.6%). Trial participants were no less likely
(Figure 1). Participant data were analysed by a researcher to seek additional training if they were allocated to the
who was not blinded to allocation, in accordance and with hypnosis group (RR 0.24, 95% CI 0.05–1.12, P = 0.07),
the ‘intention to treat’ (ITT) principle, and with compre- when compared with controls.
hensive pre-planned subgroup analyses.25 Initial analyses
examined baseline characteristics of all randomised partici- Analgesia outcomes
pants, and any chance differences in this baseline data There was no difference in our primary outcome – the use
between treatment groups were adjusted for in subsequent of pharmacological analgesia during childbirth – between

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Women ineligible (not fulfilling the


eligibility criteria) n = 140
Women assessed for eligibility
n = 776 Potentially eligible women
declining to participate n = 50

Randomisation of women
n = 586 Nulliparous = 448 Protocol violations
Multiparous = 138 Ineligible women randomised
1. Active labour n = 1
2. Gestation < 34 weeks, n = 137
Nulliparous = 99
Multiparous = 38

Randomisation of eligible participants


n = 448 nulliparous = 348 multiparous = 100

Hypnosis + CD n = 154 CD only n = 143 Control n = 151


Nulliparous = 124 Nulliparous = 110 Nulliparous = 114
Multiparous = 30 Multiparous = 33 Multiparous = 37

Analysed at birth n = 154 Analysed at birth n = 143 Analysed at birth n = 151


Excluded from analysis n = 0 Excluded from analysis n = 0 Excluded from analyses n = 0

Analysed at 6 weeks n = 134 Analysed at 6weeks n = 133 Analysed at 6weeks n = 133


Not analysed (unreturned Not analysed (unreturned Not analysed (unreturned
questionnaires) n = 20 questionnaires) n = 10 questionnaires) n = 18

Figure 1. HATCh trial flow.

groups when comparing hypnosis 125/154 (81.2%) with days in hospital after the birth (Table 3). There was also
control 115/151 (76.2%) (RR 1.07, 95% CI 0.95–1.20), and no difference in the incidence of exclusive breastfeeding at
when comparing CD only 110/143 (76.9%) with control hospital discharge, although more women in the control
(RR 1.01, 95% CI 0.89–1.15). There were also no differ- group reported that they were exclusively breast feeding at
ences found with respect to the use of epidural analgesia or 6 weeks when compared with those in the hypnosis group
other pharmacological analgesia (Table 2). (P < 0.05).
There were no differences between groups with regard to
Maternal secondary outcomes the mother perceiving that she had received adequate pain
No differences were found in key secondary outcomes with relief, or of the birth being better than expected or a posi-
respect to: mode of delivery; use of augmentation of tive experience (Table 4). There were also no differences
labour; and other birth outcomes (Table 3), including between groups regarding, perceived maternal pain inten-
median length of labour (IQR) of 8 (7.3), 8.3 (7.9), and sity, satisfaction with the birth experience, sense of control
7.4 (6.7) hours for women in the hypnosis + CD, CD only, during labour, ability to cope, or satisfaction with the
and control groups, respectively. Similarly, there was no childbirth experience (Table S2).
difference in the number of days women stayed in hospital At the 6–week assessments, there were no differences
postpartum: 4 (2) days for each group. There was an between the groups in EPDS, Spielberger, zero to 10
increased use of prostaglandins for induction in women numerical pain scores during childbirth, or satisfaction
allocated to the hypnosis group when compared with con- with the birth experience (Table S2). There were no differ-
trols, but no significant differences between groups on ences in the incidence of maternal re-admission to hospital
admission to the high dependency unit (HDU), incidence or problems related to the use of hypnosis between groups
of episiotomy, need for blood transfusion, or number of (Table S3). Those women exposed to the hypnosis or CD

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Table 1. Maternal baseline demographic data and psychological testing of HATCh participants at recruitment

Baseline demographic data Hypnosis + CD CD only Control Total


n = 154 n = 143 n = 151 n = 448

Age* 30.5, 5.1 31.4, 4.4 31.2, 4.7 31.0, 4.7


Nulliparity 124 (80.5) 110 (76.9) 114 (75.5) 348 (77.7)
BMI** 22.9, 5.5 22.9, 4.4 22, 4.2 22.7, 4.7
(n = 151) (n = 140) (n = 150) (n = 441)
Gestational age (weeks)** 35.1, 1.4 35.3, 1.6 35.0, 1.3 35.1, 1.6
Tertiary education 86 (55.8) 84 (58.7) 83 (55.0) 253 (56.5)
Australian born 112 (72.7) 107 (74.8) 111 (73.5) 330 (73.7)
Previous caesarean section 7 (4.6) 5 (3.5) 6 (4.0) 18 (4.0)
Previous epidural 20 (13.0) 20 (14.0) 18 (11.9) 58 (13.0)
History of depression*** 43 (27.9) 26 (18.2) 27 (17.9) 96 (21.4)
Complementary therapy in pregnancy 86 (55.8) 75 (52.5) 83 (55.0) 244 (54.5)
Yoga 65 (42.2) 68 (47.6) 70 (46.4) 203 (45.3)
EPDS 6, 6 5, 6 4.5, 6 (n = 150) 5, 5 (n = 447)
EPDS > 12**** 15 (9.7) 9 (6.3) 6 (4.0) 30 (6.7)
Spielberger state 30.0, 13 (n = 153) 29, 13 30, 11 30, 12 (n = 447)
Spielberger trait 32.5, 12 31, 12 30, 10 31, 12
CIS 23, 11 (n = 137) 23, 10.5 (n = 124) 23, 11 (n = 129) 23, 11 (n = 390)

BMI, body mass index; HATCh, Hypnosis Antenatal Training for Childbirth; RR, relative risk; SD, standard deviation. Numbers of women (%) are
shown, unless otherwise stated.
Hypnotisability, as measured by the CIS, anxiety, as measured by the Spielberger State–Trait Anxiety Inventory, and depression, as measured by
the EPDS, according to allocated group.
*Mean, SD.
**Median, interquartile range.
***Hypnosis versus control: RR = 1.56; P = 0.040.
****Hypnosis versus control: RR = 2.44; P = 0.058, borderline statistical significance.

Table 2. Maternal analgesia outcomes during childbirth, according to group allocation

Analgesia use during childbirth Hypnosis n = 154 CD only n = 143 Control n = 151 Total n = 448 RR (95% CI) P

Any analgesia 125 (81.2) 110 (76.9) 115 (76.2) 350 (78.1) 1.07 (0.95–1.20)* 0.348
1.01 (0.89–1.15)** 0.881
Analgesia, except Entonox 98 (64.1) 81 (56.6) 85 (56.3) 264 (59.1) 1.14 (0.95–1.37)* 0.222
1.01 (0.82–1.23)** 0.883
Epidural labour analgesia 78 (51.0) 63 (44.1) 71 (47.0) 212 (47.4) 1.08 (0.86–1.36)* 0.490
0.94 (0.73–1.20)** 0.611

Data are shown as numbers (%).


*Hypnosis versus control.
**CD versus control.

intervention were more likely to state that they would use Women who used yoga and who were allocated to
hypnosis in future pregnancies (Table S3). receive hypnosis used less analgesia than women who did
Of the planned subgroup analyses, there were no dif- not use yoga and were allocated to receive hypnosis 70.8
ferences between groups in any of the key outcomes. versus 88.8% (P = 0.005). This difference was also seen
Analgesia use during labour and childbirth subgrouped in the CD-only group, 66.2 versus 86.7% (P = 0.003),
by parity, induction, CIS score, yoga, previous experience but was not seen in the women in the control group
of clinical hypnosis, and compliance with the interven- who used or did not use yoga (Table 5), 74.3% versus
tion showed no difference between groups (Table 5). 77.8% (P = 0.616).

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Table 3. Key maternal secondary outcomes according to group allocation

Key outcomes Hypnosis + CD CD only Control Total n = 448 RR (95% CI) P


n = 154 n = 143 n = 151

Oxytocin 57 (37.3) 53 (37.1) 56 (37.1) 166 (37.1) 1.00 (0.75–1.35)* 0.976


1.00 (0.74–1.35)** 0.997
Spontaneous vaginal birth 85 (55.2) 84 (58.7) 92 (60.9) 261 (58.3) 0.91 (0.75–1.10)* 0.311
0.96 (0.80–1.16)** 0.703
Induced labour 63 (40.9) 43 (30.1) 47 (31.1) 153 (34.2) 1.31 (0.97–1.78)* 0.078
0.97 (0.69–1.36)** 0.844
Induction with prostaglandins 55 (35.7) 32 (22.4) 35 (23.2) 122 (27.2) 1.54 (1.08–2.21)* 0.018
0.97 (0.63–1.47)** 0.870
Augmentation 66 (42.9) 66 (46.2) 66 (43.7) 198 (44.2) 0.98 (0.76–1.27)* 0.881
1.06 (0.82–1.36)** 0.673
Caesarean section 38 (24.7) 25 (17.5) 29 (19.2) 92 (20.5) 1.29 (0.84–1.97)* 0.837
0.91 (0.56–1.48)** 0.561
Forceps/vacuum 31 (21.3) 34 (23.8) 30 (19.9) 95 (21.2) 1.01 (0.65–1.59)* 0.954
1.20 (0.78–1.85)** 0.418
Episiotomy 24 (15.6) 25 (17.5) 26 (17.2) 75 (16.7) 0.91 (0.55–1.50)* 0.700
1.02 (0.62–1.67)** 0.952
Intact perineum 94 (61.4) 71 (49.7) 91 (60.3) 256 (57.3) 1.02 (0.85–1.22)* 0.834
0.82 (0.67–1.02)** 0.070
PPH 24 (15.6) 22 (15.4) 14 (9.3) 60 (13.4) 1.68 (0.91–3.12)* 0.101
1.66 (0.88–3.12)** 0.115
Blood transfusion 4 (2.6) 7 (4.9) 1 (0.7) 12 (2.7) 3.92 (0.44–34.69)* 0.219
7.39 (0.92–59.33)** 0.060
Admission to HDU/ICU 3 (2.0) 7 (4.9) 2 (1.3) 12 (2.7) 1.47 (0.25–8.68)* 0.670
3.70 (0.78–17.50)** 0.099
Readmission to hospital 11 (8.2) 8 (6.0) 7 (5.3) 26 (6.5) 1.56 (0.62–3.90)* 0.342
n = 134 n = 133 n = 133 n = 400 1.14 (0.43–3.06)** 0.791
Neonatal Apgar score < 7 at 5 minutes 1 (0.7) 1 (0.7) 2 (1.3) 4 (0.9) 0.49 (0.05–5.32)* 0.555
0.53 (0.05–5.72)** 0.597
Baby admitted to SCBU 53 (34.4) 45 (31.5) 51 (33.8) 149 (33.3) 1.02 (0.75–1.39)* 0.906
0.93 (0.67–1.30)** 0.674

Data are as shown as numbers of women (%); HDU/ICU, high-dependency unit/intensive care unit; PPH, postpartum haemorrhage.
*Hypnosis versus control.
**CD versus control.

Table 4. Secondary outcomes: maternal perceptions of the birth experience

Key outcomes Hypnosis + CD CD only Control Total RR (95% CI) P


n = 154 n = 143 n = 151 n = 448

Received adequate pain relief 112 (82.4) 92 (70.2) 99 (77.3) 303 (76.7) 1.07 (0.94–1.20)* 0.313
n = 136 n = 131 n = 128 n = 395 0.91 (0.79–1.05)** 0.194
Birth a positive experience 108 (72.5) 105 (75.5) 118 (81.9) 331 (76.6) 0.89 (0.78–1.00)* 0.055
n = 149 n = 139 n = 144 n = 432 0.92 (0.82–1.04)** 0.190
Birth better than expected 59 (41.0) 44 (32.1) 46 (32.2) 149 (35.1) 1.27 (0.94–1.73)* 0.124
n = 144 n = 137 n = 143 n = 424 1.00 (0.71–1.40)** 0.993

Data are as shown as numbers of women (%).


*Hypnosis versus control.
**CD versus control.

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Table 5. Analgesia use during labour and childbirth subgrouped by parity, induction, CIS score, yoga, previous experience of clinical hypnosis,
attendance at all three sessions, and all hypnosis and CDs used at least once, versus some/all CDs not listened to (with the controls excluded from
the last two analyses)

Subgroup Hypnosis + CD CD only Control Total OR (95%CI)


n = 154 n = 143 n = 151 n = 448

Parity N 105/124 (84.7) 90/110 (81.8) 93/114 (81.6) 288/348 (82.8) 1.25 (0.63–2.46)*
1.02 (0.52–2.00)**
M 20/30 (66.7) 20/33 (66.6) 22/37 (59.5) 62/100 (62.0) 1.36 (0.50–3.72)*
1.05 (0.40–2.73)**
Induction/spontaneous I 59/63 (93.7) 39/43 (90.7) 45/47 (95.7) 143/153 (93.5) –

S 60/85 (70.6) 68/97 (70.1) 67/101 (66.3) 195/283 (68.9) 1.22 (0.65–2.27)*
1.19 (0.65–2.17)**
CIS score <23 50/60 (83.3) 48/60 (80.0) 45/63 (71.4) 143/183 (78.1) 2.00 (0.84–4.78)*
1.60 (0.69–3.69)**
≥23 63/77 (81.8) 47/64 (73.4) 52/66 (78.8) 162/207 (78.3) 1.21 (0.53–2.77)*
0.74 (0.33–1.67)**
Yoga Y 46/65 (70.8) 45/68 (66.2) 52/70 (74.3) 143/203 (70.4) 0.84 (0.39–1.79)*
0.68 (0.33–1.41)**
N 79/89 (88.8) 65/75 (86.7) 63/81 (77.8) 207/245 (84.5) 2.26 (0.97–5.23)*
1.86 (0.80–4.33)**
Previous experience of clinical hypnosis Y 8/12 (66.7) 3/5 (60.0) 9/13 (69.2) 20/30 (66.7) –

N 117/142 (82.4) 107/138 (77.5) 106/138 (76.8) 330/418 (79.0) 1.39 (0.79–2.44)*
1.18 (0.67–2.08)**
Three hypnosis sessions Y 55/68 (80.9) 44/57 (77.2) 99/125 (79.2) 1.25 (0.53–2.97)*
N 70/86 (81.4) 66/86 (76.7) 136/172 (79.1) 1.33 (0.63–2.77)**
All CDs listened to Y 45/58 (77.6) 45/66 (68.2) 90/124 (72.6) 1.62 (0.72–3.62)*
N 68/79 (86.1) 59/70 (84.3) 127/149 (85.2) 1.15 (0.47–2.85)***

Data are shown as numbers (%); –, too few numbers to perform OR analyses.
*Hypnosis versus control.
**CD versus control.
***Hypnosis versus CD.

Approximately 15% of babies had meconium-stained the use of pharmacological analgesia during labour and
liquor across the groups, and one-third of babies were childbirth. In addition, mode of delivery and the use of
admitted to the special care baby unit (SCBU). However, oxytocics were similarly unaffected. An unexpected finding
there were no differences in the incidence of meconium- of our study was that women allocated to the hypno-
stained liquor, babies with an Apgar score < 7 at 5 min- sis + CD group had an increased incidence of having an
utes, and admissions to the SCBU, between the three induction of labour and prostaglandin administration.
groups (Table 3). Hypnosis has been used as an intervention to induce
Nearly 50% of women in the intervention groups labour.40 Whether this was a chance occurrence or not, any
believed that hypnosis was helpful during the birth. No effect of hypnosis in reducing analgesia may have been
differences were reported with respect to incidence of baby masked by more painful, induced labour. Apart from this
re-admissions to hospital and whether the baby was settled outcome, there was a surprising lack of statistically signifi-
or not (Table S4). cant findings between groups. Of the planned subgroup
analyses there were no differences between groups in any
of the key outcomes; however, it was interesting to note
Discussion
that women who used yoga and who were allocated to
Main findings receive hypnosis used less analgesia than women who did
The key finding of the HATCh trial is that antenatal group not use yoga and were allocated to receive hypnosis. Like
hypnosis training in the third trimester, using the particu- hypnosis, yoga also involves the use of imagery, positive
lar three-session regimen of this study, did not influence suggestion and ‘trance-like’ states. The familiarity with

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The Hypnosis Antenatal Training for Childbirth trial

these states may have primed this subgroup of women to trial participants had a post-school qualification (Table 1).
learn the hypnosis techniques taught in this study over a These highly educated women may not be representative of
shorter period of time. the pregnant population of other studies where hypnosis
training has been found to be effective.
Strengths and weaknesses Previous studies, where a beneficial effect has been
The HATCh trial was a comprehensive, high-quality, shown, have used more than three antenatal sessions,21,23,24
randomised trial that was designed to assess the efficacy of and administered the intervention at an earlier gestation
a short, three-session, standardised hypnosis intervention in than we did in our study.23,24 Interestingly, a previous
late pregnancy. Strengths included: the health significance randomised trial where hypnosis failed to reduce analgesia
of the issue; the inclusion of both nulliparous and multipa- requirements during labour also had a design that involved
rous women; the comprehensive, clinically meaningful beginning the antenatal hypnosis training late in the third
nature of the outcomes chosen; the support of preliminary trimester.20 The ready availability of epidural analgesia may
studies and meta-analyses; and the investigators’ experience also have influenced our study findings. If epidural analge-
with the intervention. A rigorous experimental design was sia is not available on demand, as appeared the case in
used and similar groups at baseline were achieved by using previous studies with positive findings, the likelihood that
balanced randomisation, stratified for parity. Prior to this hypnosis will reduce analgesia use may be increased. Many
trial, only one study had a comparable sample size but was medical interventions in our institution are protocol
much less rigorous in its methodology, and made no driven. In this regard, there may have been rates of inter-
attempt to standardise the intervention.24 All other previ- vention, such as caesarean section or epidural use during
ous hypnosis studies in this setting have recruited <100 labour and childbirth, in this tertiary setting that were not
participants. The use of the CDs was an innovative feature amenable to change by the hypnosis intervention. In
of the study, with which investigators attempted to stan- another study investigating continuous support in labour
dardise the suggestions used during the intervention and provided to a low-risk population, in general greater bene-
facilitate replication should the findings had shown efficacy. fits were found when epidural analgesia was not routinely
The psychological measures for depression and anxiety available, including: decreased caesarean section rates and
have been previously validated in this setting. The CIS used increased spontaneous vaginal birth.42 Future areas of
for hypnotisability assessments were standardised by using research might include: a comparison of antenatal hypnosis
an identical CD of the scale and response sheets adminis- training inside and outside a tertiary referral centre, where
tered on an individual basis to trial participants at trial an ‘on demand’ epidural service is unavailable; the use of
entry. This had the advantage of avoiding a formal different methods to teach hypnosis preparation for labour
hypnotic induction, which minimised the possibility of analgesia; and using yoga as part of the hypnosis training
contaminating our control group with an experience of regimen.
hypnosis. The planned primary outcome of reduced phar-
macological analgesic intervention was a reasonable objec- Interpretation
tive, as it was absolute and relatively easy to measure. The HATCh trial represents the best-quality evidence to
The HATCh trial had several limitations. Firstly, there date investigating the effects of hypnosis training on anal-
were a number of post-randomisation exclusions resulting gesia use during childbirth.43,44 The negative findings may
from an inadvertent error during the eligibility assessment convince many that it is ineffective in the clinical environ-
of gestation at trial entry. We therefore continued recruit- ment we have explored, irrespective of timing or tech-
ing until our initial planned sample size had been reached, niques, and it may not be worthwhile pursuing lengthier
a strategy consistent with a suggested approach for the and less feasible approaches in the hope of gaining benefit
management of inadvertently recruiting ineligible subjects in a tertiary referral setting with an ‘on demand’ epidural
after randomisation.41 Only a minority of women actually service. Although our findings show that the HATCh inter-
attended all three sessions and listened to all four CDs; vention in late pregnancy cannot be recommended, the rig-
however, our subgroup analyses do not support poor com- orous methodology used provides a potentially useful
pliance as a reason for the lack of efficacy of the hypnosis template for the conduct of future investigations assessing
intervention. Although every attempt was made to conceal the effectiveness of different ways of administering a
treatment allocations from obstetricians, anaesthetists, mid- hypnosis intervention for pain relief and other beneficial
wives, and the personnel collecting data, double-blinding a outcomes in childbirth.
hypnosis intervention is unlikely if women are not fully
informed, as in earlier studies.21–23 Disclosure of interests
About 80% of all women in our institution received All authors have completed the Unified Competing Inter-
pharmaceutical analgesia. A high proportion of HATCh est form at http://www.icmje.org/coi_disclosure.pdf (avail-

ª 2013 RCOG 1255


Cyna et al.

able on request from the corresponding author), and


Supporting Information
declare: support from the University of Adelaide; Austra-
lian Society of Anaesthetists; the Women’s and Children’s Additional Supporting Information may be found in the
Foundation; and NH&MRC project grant 453446. This online version of this article:
paper represents, in part, the PhD thesis http://digi- Table S1. Number of sessions attended by trial partici-
tal.library.adelaide.edu.au/dspace/bitstream/2440/69216/1/ pants and self-reported compliance with listening to audio
02whole.pdf. Dr Allan Cyna is a co-author of the Cochra- CD on hypnosis, according to allocated group.
ne review that includes, in part, data from the HATCh Table S2. Maternal psychological and perceived child-
trial reported in this article. There were no other relation- birth pain outcomes at 6 weeks postpartum follow-up.
ships or activities that could appear to have influenced Table S3. Maternal outcomes at 6 weeks postpartum.
the submitted work. Table S4. Neonatal outcomes at 6 week assessment post-
partum.
Contribution to authorship Data S1. Powerpoint slides summarising the study. &
AMC, MIA, JSR, and CAC have contributed to the over-
all concept and design. AMC and MIA helped design and
References
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interventions. PB and GA organised the acquisition of 1 Yapko M. Trancework: An Introduction to the Practice of Clinical
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16 Wong L, Cyna AM, Matthews G. Rapid hypnosis as an anaesthesia
also acknowledge research assistance from Denise Healy, adjunct for evacuation of postpartum vulval haematoma. Aust N Z J
Karen Belchambers, Carmel Mercer, Louise Goodchild, Obstet Gynaecol 2011;51:265–7.
Meredith Krieg, Ros Lontis, Deni Haines, Pat Ashwood, 17 Minnich M. Childbirth preparation and nonpharmacologic analgesia.
Andrea Deussen and administrative assistance form Cindy- In: Chestnut DH, editor. Obstetric Anesthesia: Principles and
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Commentary on ‘Hypnosis antenatal training for childbirth


(HATCh): a randomised controlled trial’
This trial provides a good example of a multi-arm study. Multi-arm studies are becoming more prevalent in medical
research. The main advantage to this type of study is that they allow the testing of more than one potential or promising
intervention. In the example cited above there are two intervention arms: a group with hypnosis plus CD and a group
with CD only, and the study is then completed with a third control arm that received no intervention above treatment
as usual. Comparing the two intervention arms with a shared control arm reduces the required sample size by 25%, and
in turn can reduce both the time and cost required to conduct the study (Freidlin et al., Clin Cancer Res 2008;14:4368–
71). It has also been suggested that multi-arm studies may be more attractive to potential participants because it
increases the chance that they will be randomised to a treatment arm rather than the control arm.
In general terms, multi-arm studies are designed and analysed in a similar way to the traditional two-arm study
(Appraising multi-arm RCTs, www.clinicalevidence.bmj.com). Prior to starting the study the comparisons to be made
should be listed and a formal sample size estimated. An interim analysis may prove valuable, after 50% of the partici-
pants have completed the study. This will allow any arms that are unlikely to show efficacy to be identified and dropped
from the study (Watson and Jaki Stats Med 2012;31:4269–79). This, in turn, will reduce the required sample size, and

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Cyna et al.

possibly shorten the recruitment time and cost. This type of adaptive design is becoming the norm in most clinical tri-
als.
A more controversial issue in the design and analysis of multi-arm studies is the use of multiple testing (Freidlin
et al., Clin Cancer Res 2008;14:4368–71; Appraising multi-arm RCTs, www.clinicalevidence.bmj.com). Most studies are
powered to detect a difference in the primary outcome at the 5% significance level. Statistically this means that there is
a 5% chance of rejecting the null hypothesis when it is actually true; however, when there is more than one primary out-
come being tested the risk of rejecting the null hypothesis increases as the number of tests increase. Consequently, when
two intervention arms are being compared with a common control arm there could be an 8% risk of obtaining a false
result. There are a number of adjustments that can be made to reduce this risk, one of the simplest and commonly used
approaches is known as the Bonferroni correction, which divides the initial significance level by the number of tests
being performed, so if two tests were being carried out, with an initial significance level of 5%, then the significance level
of each individual test would be 2.5%. However, it is now being argued that if the two comparisons were made in sepa-
rate studies then no correction would be required. Consequently, a more realistic approach may be to use the initial sig-
nificance level, e.g. 5%, if the tests are independent, and to apply a Bonferroni correction or other adjustment method if
the tests are related.
In summary, multi-arm studies can reduce the required sample size when comparing two or more interventions, com-
pared with the more traditional approach of undertaking a separate study for each intervention under consideration.
Reducing the sample size and ultimately the cost of studies increases the probability of obtaining definitive results. &

S Lane
Department of Biostatistics, University of Liverpool, L69 3GS, UK

Journal club

Scenario
During her routine antenatal visit, a patient in her third trimester of pregnancy was keen to discuss analgesia and relaxa-
tion techniques during pregnancy. She asked ‘One of my friends had hypnosis when she was pregnant. Does it work?’

Structured question

Participants Women between 34+0 and 39+0 weeks gestation, planning a vaginal birth
Intervention (i) Group hypnosis sessions plus hypnotherapist-guided audio CDs
(ii) Hypnotherapist-guided audio CDs only
Comparison No additional antenatal intervention
Outcomes Primary outcome: use of pharmacological analgesia during labour.
Secondary outcomes: selected maternal and neonatal outcomes, including use of augmentation,
mode of delivery, and neonatal Apgar scores.
Study design Randomised controlled trial (1:1:1 design)

Discussion points
1. Background: What is hypnosis? What are the potential risks and benefits of using hypnosis before and during child-
birth?
2. Methods: Critically appraise, do not simply accept on face value, the methods of this trial. In particular, what are the
potential concerns of analysing participant data by a researcher unblinded to allocation?
3. Results: What are the ethical and practical concerns of protocol violations? Are there recognised methods to deal with
these concerns?

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The Hypnosis Antenatal Training for Childbirth trial

4. Relevance to your practice: Were the demographics of the participants in this trial similar to your practice? How does
it affect your interpretation of this study?
5. Take-home message: In a single sentence, how would you describe the available evidence of antenatal hypnosis for
pain relief in childbirth? (Data S1)

EYL Leunga & D Siassakosb


a
Women’s Health Research Unit, Centre of Public Health and Primary Care, Queen Mary,
University of London, Yvonne Carter Building, 58 Turner Street, E1 2AB, London, UK
b
School of Clinical Sciences, University of Bristol, The Chilterns, Southmead Hospital, BS10 5NB, Bristol, UK

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please refer to BJOG 2013;120:657–660. http://bit.ly/10VaiRZ

ª 2013 RCOG 1259

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