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

Women's and Children's Hospital, Australia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Labor; Pregnancy

Treatments: Behavioral: Audio compact disc on hypnosis; Behavioral: antenatal hypnosis + audio compact disc on hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT00282204

ACTRN012605000018617

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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448 participants in 3 patient groups

Control

No Intervention group

Description:

Usual care control

Hypnosis + CD

Experimental group

Description:

Hypnosis plus audio cd on hypnosis

Treatment:

Behavioral: antenatal hypnosis + audio compact disc on hypnosis

Audio CD on Hypnosis

Active Comparator group

Description:

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

Treatment:

Behavioral: Audio compact disc on hypnosis