Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000018617
Ethics application status
Approved
Date submitted
11/07/2005
Date registered
18/07/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypnosis Antenatal Training for CHildbirth (HATCh)
A randomised controlled trial
Scientific title
The effects of antenatal hypnosis on pain relief in labour
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
>34 weeks gestation 80 0
Condition category
Condition code
Reproductive Health and Childbirth 98 98 0 0
Antenatal care
Alternative and Complementary Medicine 99 99 0 0
Pain management
Alternative and Complementary Medicine 100 100 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Antenatal group hypnosis vs Hypnosis CD vs no intervention
The intervention involves 3 sessions of hypnosis after 34 weeks gestation at weekly intervals in groups of up to 10 women.
Intervention code [1] 8 0
Prevention
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 124 0
Use of analgesia during childbirth
Timepoint [1] 124 0
During childbirth
Secondary outcome [1] 287 0
Mode of delivery
Timepoint [1] 287 0
Measured at baseline and at 6 weeks and 6 months post partum.
Secondary outcome [2] 288 0
Anxiety and postnatal depression scores.
Timepoint [2] 288 0
Measured at baseline and at 6 weeks and 6 months post partum.

Eligibility
Key inclusion criteria
Previous hypnosis for childbirth; woman definitely wants an epidurtal or hypnosis; Not singleton live fetus before 34 weeks gestation; Other conditions causing pain; Active psychiatric illness.
Minimum age
Not stated
Maximum age
34 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Central registry by telephone or computer allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers stratified for parity
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 134 0
Charities/Societies/Foundations
Name [1] 134 0
Australian Society of Anaesthetists
Country [1] 134 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 96 0
Hospital
Name [1] 96 0
Women's and Children's Hospital
Address [1] 96 0
Country [1] 96 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 886 0
Women's and Children's Hospital LREC
Ethics committee address [1] 886 0
Ethics committee country [1] 886 0
Australia
Date submitted for ethics approval [1] 886 0
Approval date [1] 886 0
Ethics approval number [1] 886 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35520 0
Address 35520 0
Country 35520 0
Phone 35520 0
Fax 35520 0
Email 35520 0
Contact person for public queries
Name 9197 0
Dr A.M.Cyna
Address 9197 0
Department of Anaesthesia
Women's and Children's Hospital
Adelaide SA 5006
Country 9197 0
Australia
Phone 9197 0
+61 8 81617000
Fax 9197 0
Email 9197 0
[email protected]
Contact person for scientific queries
Name 125 0
Dr A.M.Cyna
Address 125 0
Department of Anaesthesia
Women's and Children's Hospital
Adelaide SA 5006
Country 125 0
Australia
Phone 125 0
+61 8 81617000
Fax 125 0
Email 125 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.