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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282204
• Other study ID #: ACTRN012605000018617
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 24, 2006
• Last updated: June 28, 2012
• Start date: December 2005
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Women's and Children's Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Labor
• Pregnancy

Intervention

Behavioral:
• antenatal hypnosis + audio compact disc on hypnosis

• Audio compact disc on hypnosis

Locations

Country	Name	City	State
Australia	Women's and Children's Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Women's and Children's Hospital, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	1. Maternal rating of the overall pain experienced during labour and childbirth		Usually within 48 hours or before discharge from hospital	No
Secondary	2. Mode of delivery		Within 24 hours of the birth	Yes
Secondary	3. Use of oxytocics		Within 24 hours of the birth	Yes
Secondary	4. Postnatal depression		At 6 weeks and 6 months postnatal	Yes
Secondary	5. Maternal anxiety		At 6 weeks and 6 months postnatal	No
Secondary	6. Neonatal Apgar score at 5 minutes < 7		within 24 hours of birth	Yes
Secondary	7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)		within 24 hours of birth	Yes
Secondary	8. Maternal rating whether the birth experience was. Worse / better / same as expected		within 24 hours of birth	No
Secondary	9. Maternal rating of control during the labour during the birth		within 24 hours of birth	No
Secondary	10. Maternal rating whether the birth was rated positive or negative experience		within 24 hours of birth	No
Secondary	11. Length of neonatal nursery stay		within 24 hours of birth	Yes
Secondary	12. Length of maternal stay in hospital		within 6 months of the birth	Yes
Secondary	13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months		6 months after birth	No