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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00282204




Registration number
NCT00282204
Ethics application status
Date submitted
24/01/2006
Date registered
25/01/2006
Date last updated
29/06/2012

Titles & IDs
Public title
Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
Scientific title
Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
Secondary ID [1] 0 0
ACTRN012605000018617
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 0 0
Labor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention: Control - Usual care control

Experimental: Hypnosis + CD - Hypnosis plus audio cd on hypnosis

Active comparator: Audio CD on Hypnosis - Audio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Within 24 hours of the birth
Secondary outcome [1] 0 0
1. Maternal rating of the overall pain experienced during labour and childbirth
Timepoint [1] 0 0
Usually within 48 hours or before discharge from hospital
Secondary outcome [2] 0 0
2. Mode of delivery
Timepoint [2] 0 0
Within 24 hours of the birth
Secondary outcome [3] 0 0
3. Use of oxytocics
Timepoint [3] 0 0
Within 24 hours of the birth
Secondary outcome [4] 0 0
4. Postnatal depression
Timepoint [4] 0 0
At 6 weeks and 6 months postnatal
Secondary outcome [5] 0 0
5. Maternal anxiety
Timepoint [5] 0 0
At 6 weeks and 6 months postnatal
Secondary outcome [6] 0 0
6. Neonatal Apgar score at 5 minutes < 7
Timepoint [6] 0 0
within 24 hours of birth
Secondary outcome [7] 0 0
7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)
Timepoint [7] 0 0
within 24 hours of birth
Secondary outcome [8] 0 0
8. Maternal rating whether the birth experience was. Worse / better / same as expected
Timepoint [8] 0 0
within 24 hours of birth
Secondary outcome [9] 0 0
9. Maternal rating of control during the labour during the birth
Timepoint [9] 0 0
within 24 hours of birth
Secondary outcome [10] 0 0
10. Maternal rating whether the birth was rated positive or negative experience
Timepoint [10] 0 0
within 24 hours of birth
Secondary outcome [11] 0 0
11. Length of neonatal nursery stay
Timepoint [11] 0 0
within 24 hours of birth
Secondary outcome [12] 0 0
12. Length of maternal stay in hospital
Timepoint [12] 0 0
within 6 months of the birth
Secondary outcome [13] 0 0
13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months
Timepoint [13] 0 0
6 months after birth

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
448
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide

Funding & Sponsors
Primary sponsor type
Government body
Name
Women's and Children's Hospital, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00282204
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Marion I Andrew, FANZCA
Address 0 0
Women's and Children's Hospital, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00282204