Clinical trial NCT00282204: Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
Official title: Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pregnancy
Labor
Keywords: Hypnosis
Hypnotherapy
Childbirth
Analgesia
Lead sponsor: Women's and Children's Hospital, Australia
Sponsor class: OTHER_GOV
First posted: 2006-01-25
Enrollment: 448
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: Within 24 hours of the birth
Secondary outcomes:
measure: 1. Maternal rating of the overall pain experienced during labour and childbirth
timeFrame: Usually within 48 hours or before discharge from hospital
measure: 2. Mode of delivery
timeFrame: Within 24 hours of the birth
measure: 3. Use of oxytocics
timeFrame: Within 24 hours of the birth
measure: 4. Postnatal depression
timeFrame: At 6 weeks and 6 months postnatal
measure: 5. Maternal anxiety
timeFrame: At 6 weeks and 6 months postnatal
measure: 6. Neonatal Apgar score at 5 minutes < 7
timeFrame: within 24 hours of birth
measure: 7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)
timeFrame: within 24 hours of birth
measure: 8. Maternal rating whether the birth experience was. Worse / better / same as expected
timeFrame: within 24 hours of birth
measure: 9. Maternal rating of control during the labour during the birth
timeFrame: within 24 hours of birth
measure: 10. Maternal rating whether the birth was rated positive or negative experience
timeFrame: within 24 hours of birth
measure: 11. Length of neonatal nursery stay
timeFrame: within 24 hours of birth
measure: 12. Length of maternal stay in hospital
timeFrame: within 6 months of the birth
measure: 13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months
timeFrame: 6 months after birth
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
Study officials:
affiliation: Women's and Children's Hospital, Australia
name: Marion I Andrew, FANZCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's and Children's Hospital, Australia
name: Allan M Cyna, FRCA
role: STUDY_DIRECTOR
References:
citation: 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.