Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00282204