Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000127404
Ethics application status
Approved
Date submitted
9/02/2007
Date registered
12/02/2007
Date last updated
30/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypnosis for nausea and vomiting in early pregnancy: a randomised controlled trial
Scientific title
The effects of antenatal hypnosis on suffering associated with hyperemesis in early pregnancy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperemesis in early pregnancy 1619 0
Condition category
Condition code
Reproductive Health and Childbirth 1727 1727 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Usual Care (supportive and pharmacological medication and /or intravenous fluids as required) plus Audio CD on Hypnosis lasting 1/2 hour for 7 consecutive days
Intervention code [1] 1593 0
Treatment: Other
Comparator / control treatment
Control: Usual Care (as described above)
Control group
Active

Outcomes
Primary outcome [1] 2398 0
Suffering associated with nausea and vomiting as measured by 5 point Likert Scale
Timepoint [1] 2398 0
On days 2, 7 and 14 following allocation
Secondary outcome [1] 4166 0
Incidence of Nausea in previous 24 hours
Timepoint [1] 4166 0
On Days 2,7,14
Secondary outcome [2] 4167 0
Incidence of Vomiting in previous 24 hours
Timepoint [2] 4167 0
On Days 2,7,14
Secondary outcome [3] 4168 0
Anxierty as measured by Spielberger
Timepoint [3] 4168 0
Baseline and at 14 days
Secondary outcome [4] 4169 0
Number of Days off work at Day 14 in previous 7 days
Timepoint [4] 4169 0
Baseline and day 14

Eligibility
Key inclusion criteria
Suffering from nausea and vomiting of pregnancy.
Minimum age
16 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Active psychological or psychiatric illness, poor understanding of english; underlying medical or obstetric condition contributing to nausea and vomiting.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque consecutively numbered sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not 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
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1876 0
Self funded/Unfunded
Name [1] 1876 0
Country [1] 1876 0
Australia
Primary sponsor type
Individual
Name
Dr A.M Cyna
Address
Dept.Women’s Anaesthesia
Women’s and Children’s Hospital
Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 1691 0
None
Name [1] 1691 0
Address [1] 1691 0
Country [1] 1691 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3501 0
Child Youth and Women's Health service
Ethics committee address [1] 3501 0
Ethics committee country [1] 3501 0
Australia
Date submitted for ethics approval [1] 3501 0
Approval date [1] 3501 0
Ethics approval number [1] 3501 0

Summary
Brief summary
Primary purpose of the study is to investigate whether antenatal hypnosis decreases the suffering associated with nausea and vomiting of pregnancy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27527 0
Address 27527 0
Country 27527 0
Phone 27527 0
Fax 27527 0
Email 27527 0
Contact person for public queries
Name 10782 0
Dr A.M.Cyna
Address 10782 0
Department of Women's Anaesthesia, Women's and Children's Hospital, 72 King William Rd, Adelaide, SA 5006
Country 10782 0
Australia
Phone 10782 0
08 81617000
Fax 10782 0
Email 10782 0
[email protected]
Contact person for scientific queries
Name 1710 0
Dr A.M.Cyna
Address 1710 0
Department of Women's Anaesthesia, Women's and Children's Hospital, 72 King William Rd, Adelaide, SA 5006
Country 1710 0
Australia
Phone 1710 0
08 81617000
Fax 1710 0
Email 1710 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.