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Study 1 of 1 for search of: | "Women's and Children's Hospital, Australia" [Exact] |
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Brief Title † | Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial | ||||||||
Official Title † | Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial | ||||||||
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. |
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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. |
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Study Phase | Phase II, Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Safety/Efficacy Study | ||||||||
Primary Outcome 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 | ||||||||
Secondary Outcome Measure † | 1. Maternal rating of the overall pain experienced during labour and childbirth 2. Mode of delivery 3. Use of oxytocics 4. Postnatal depression 5. Maternal anxiety 6. Neonatal Apgar score at 5 minutes < 7 7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU) 8. Maternal rating whether the birth experience was. Worse / better / same as expected 9. Maternal rating of control during the labour during the birth 10. Maternal rating whether the birth was rated positive or negative experience 11. Length of neonatal nursery stay 12. Length of maternal stay in hospital 13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months |
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Condition † | Pregnancy Analgesia |
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Intervention † | Behavioral: antenatal hypnosis + audio compact disc on hypnosis Behavioral: Audio compact disc on hypnosis |
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Recruitment Information Fields | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 450 | ||||||||
Start Date † | December 2005 | ||||||||
Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
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 |
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Gender | Female | ||||||||
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Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Australia | ||||||||
Administrative Information Fields | |||||||||
NCT ID † | NCT00282204 | ||||||||
Organization ID | ACTRN012605000018617 | ||||||||
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Study Sponsor † | Women's and Children's Hospital, Australia | ||||||||
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Information Provided By | Women's and Children's Hospital, Australia | ||||||||
Verification Date | January 2006 | ||||||||
First Received Date † | January 24, 2006 | ||||||||
Last Updated Date | January 24, 2006 |