Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial

Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Labor
• Intervention / Treatment: Behavioral: antenatal hypnosis + audio compact disc on hypnosis; Behavioral: Audio compact disc on hypnosis

Detailed Description

Background: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.

Methods / Design: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 < 39 weeks gestation, with a singleton, viable fetus, vertex presentation, who are not in active labour or planning a vaginal birth are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups are trained as near as possible to 37 weeks gestation. Group allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women / group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia - the primary endpoint. We estimate that approximately 5-10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women / group and perform interim analyses when 150 and 300 participants have been recruited. All participants will be analysed according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses.

Discussion: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and provide evidence to guide clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5006
      • Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women > 34 < 39 weeks gestation; singleton, viable fetus, vertex presentation, who are not in active labour (active labour is defined as cervical effacement and dilatation associated with regular uterine contractions) and who are planning a vaginal birth.

Exclusion Criteria:

• Previous hypnosis preparation for childbirth;
• poor understanding of English requiring translator;
• women who are already enrolled in another pregnancy trial where analgesia requirements are an outcome measure;
• active psychological or psychiatric problems such as: active depression requiring treatment by a psychiatrist;
• schizophrenia;
• prior psychosis;
• severe intellectual disability.
• Women with pain caused by specific pathological entities such as: congenital neuromuscular disorders; spina bifida; metastatic disease; osteoporosis; rheumatoid arthritis; fractures,are also excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual care control
Experimental: Hypnosis + CD; Hypnosis plus audio cd on hypnosis	Behavioral: antenatal hypnosis + audio compact disc on hypnosis
Active Comparator: Audio CD on Hypnosis; Audio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation	Behavioral: Audio compact disc on hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The use of pharmacological analgesia during labour and childbirth will be collected from the birth register where all analgesia is documented by the attending midwife	Within 24 hours of the birth

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Maternal rating of the overall pain experienced during labour and childbirth	Usually within 48 hours or before discharge from hospital
2. Mode of delivery	Within 24 hours of the birth
3. Use of oxytocics	Within 24 hours of the birth
4. Postnatal depression	At 6 weeks and 6 months postnatal
5. Maternal anxiety	At 6 weeks and 6 months postnatal
6. Neonatal Apgar score at 5 minutes < 7	within 24 hours of birth
7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)	within 24 hours of birth
8. Maternal rating whether the birth experience was. Worse / better / same as expected	within 24 hours of birth
9. Maternal rating of control during the labour during the birth	within 24 hours of birth
10. Maternal rating whether the birth was rated positive or negative experience	within 24 hours of birth
11. Length of neonatal nursery stay	within 24 hours of birth
12. Length of maternal stay in hospital	within 6 months of the birth
13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months	6 months after birth

Collaborators and Investigators

• Sponsor: Women's and Children's Hospital, Australia
• Investigators: Principal Investigator: Marion I Andrew, FANZCA, Women's and Children's Hospital, Australia; Study Director: Allan M Cyna, FRCA, Women's and Children's Hospital, Australia

Publications and helpful links

General Publications

• Cyna AM, Andrew MI, Robinson JS, Crowther CA, Baghurst P, Turnbull D, Wicks G, Whittle C. Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]. BMC Pregnancy Childbirth. 2006 Mar 5;6:5. doi: 10.1186/1471-2393-6-5.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 24, 2006
• First Submitted That Met QC Criteria: January 24, 2006
• First Posted (Estimate): January 25, 2006

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Analgesia; Hypnosis; Hypnotherapy; Childbirth
• Other Study ID Numbers: ACTRN012605000018617