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

This study has been completed.
Sponsor:
Information provided by:
Women's and Children's Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00282204
First received: January 24, 2006
Last updated: June 28, 2012
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Pregnancy
Labor
Behavioral: antenatal hypnosis + audio compact disc on hypnosis
Behavioral: Audio compact disc on hypnosis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Women's and Children's Hospital, Australia:

Primary Outcome Measures:
  • 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 [ Time Frame: Within 24 hours of the birth ] [ Designated as safety issue: Yes ]

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

Enrollment: 448
Study Start Date: December 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00282204

Locations
Australia, South Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia, 5006
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Dr A.M.Cyna, CYWHS
ClinicalTrials.gov Identifier: NCT00282204     History of Changes
Other Study ID Numbers: ACTRN012605000018617
Study First Received: January 24, 2006
Last Updated: June 28, 2012
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Women's and Children's Hospital, Australia:
Hypnosis
Hypnotherapy
Childbirth
Analgesia

ClinicalTrials.gov processed this record on July 22, 2014