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

NCT ID: NCT00282204

Last Updated: 2012-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Pregnancy; Labor

Keywords

Hypnosis; Hypnotherapy; Childbirth; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Usual care control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypnosis + CD

Hypnosis plus audio cd on hypnosis

Group Type: EXPERIMENTAL

antenatal hypnosis + audio compact disc on hypnosis

Intervention Type: BEHAVIORAL

Audio CD on Hypnosis

Audio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation

Group Type: ACTIVE_COMPARATOR

Audio compact disc on hypnosis

Intervention Type: BEHAVIORAL

Interventions

antenatal hypnosis + audio compact disc on hypnosis

Intervention Type: BEHAVIORAL

Audio compact disc on hypnosis

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's and Children's Hospital, Australia

OTHER_GOV

Sponsor Role: lead

Responsible Party

CYWHS

Principal Investigators

Marion I Andrew, FANZCA

Role: PRINCIPAL_INVESTIGATOR

Women's and Children's Hospital, Australia

Allan M Cyna, FRCA

Role: STUDY_DIRECTOR

Women's and Children's Hospital, Australia

Locations

Women's and Children's Hospital

Adelaide, South Australia, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 16515709 (View on PubMed)

Other Identifiers

ACTRN012605000018617

Identifier Type: -

Identifier Source: org_study_id