Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000051549
Ethics application status
Approved
Date submitted
31/01/2006
Date registered
6/02/2006
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A Creative-Arts therapy ante-natal psycho-educational program for first-time mothers
Scientific title
Examining the effectiveness of a creative-arts therapy ante-natal intervention program in comparison with an informal ante-natal birth support group for first-time mothers, on reducing levels of depression, anxiety and the use of analgesics during labour.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 1013 0
Anxiety 1014 0
Birth outcomes of first-time mothers. 1015 0
Condition category
Condition code
Mental Health 1089 1089 0 0
Depression
Mental Health 1090 1090 0 0
Anxiety
Reproductive Health and Childbirth 1091 1091 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research will now compare three groups of first-time mothers, a creative arts intervention program, an informal birth support group and a control group that does not receive any intervention within the study. Both intervention groups receive two hour weekly sessions over an eight week period that includes a general discussion of issues that arise for the women in relation to their pregnancy. In addition, the creative arts intervention group recieve a regular relaxation/meditation program that targets pain management during the three stages of labour. The creative arts program also engage in group discussion and complete worksheets around four topics aimed at assisting women to prepare more effectively for labour, birth and early motherhood. Participants of all intervention groups will attend one of the hospital's ante-natal programs. All participants will complete standardardised questionnaires (prior to the program), and other questionnaires designed by leading professionals in the field of mother-baby research, in order to determine levels of anxiety, depression and general health. Relevant demographic information will also be collected.
Questionnaires will also be adminstered after the baby's birth in order in order to assess birth outcomes. Outcomes on depression, anxiety and general health will be evaluated two months post-natally.


The study has been deemed a pilot project for a larger scale study, therefore it is no longer considered to be a randomised controlled trial. Allocation to groups was based on partial randomisation. Allocations to the intervention or control group was based on the availability of the participant and whether the day/time of the program fitted in with the mother's schedule. Therefore, participants chose a suitable time/day that they could attend but were not informed of which group they were allocated to until their first session. Those who could not attend often opted to participate in the questionnaire only control group.
Intervention code [1] 873 0
None
Comparator / control treatment
The control group is also a group of first-time mothers who will complete the standardised questionnaires and additional questionnaires at the same time as the two research ante-natal programs. The questionnaire only group also attend one of the hospital ante-natal programs. The women were primarily recruited directly to the questionnaire only program after the recruitment for the intervention programs had been completed. If women could not attend the intervention program they generally indicated that they were available for the questionnaire only group and were recruited to that group.
Control group
Active

Outcomes
Primary outcome [1] 1454 0
Anxiety postnatally
Timepoint [1] 1454 0
At 2 months after birth
Primary outcome [2] 1455 0
Depression postnatally
Timepoint [2] 1455 0
At 2 months after birth
Primary outcome [3] 1456 0
Rate of epidural use at birth
Timepoint [3] 1456 0
Measured in the first week after birth.
Secondary outcome [1] 2609 0
Level of birth satisfaction
Timepoint [1] 2609 0
Measured in the first week after the birth.

Eligibility
Key inclusion criteria
First-time mothers with good spoken English, in order to participate in the intervention or control program.
Minimum age
20 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any history of psychiatric disorders or a medical condition which would preclude a spontaneous vaginal birth.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical trial is now a partially randomised controlled trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clinical trial is now a partially randomised controlled trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1193 0
University
Name [1] 1193 0
Monash University
Clayton Campus
Faculty of Education
Country [1] 1193 0
Australia
Primary sponsor type
Individual
Name
Primrose White
Address
13 Manorwood Place
Mitcham, 3132
Victoria
Country
Australia
Secondary sponsor category [1] 1054 0
None
Name [1] 1054 0
Address [1] 1054 0
Country [1] 1054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2513 0
Monash University Standing Committee on Ethics in Research Involving Humans
Ethics committee address [1] 2513 0
Ethics committee country [1] 2513 0
Australia
Date submitted for ethics approval [1] 2513 0
Approval date [1] 2513 0
Ethics approval number [1] 2513 0
2006/610MC - Original SCERH Number
CF07/3555 - 2006000610MC - Update SCERH Number
Ethics committee name [2] 2514 0
Ethics committee address [2] 2514 0
Ethics committee country [2] 2514 0
Australia
Date submitted for ethics approval [2] 2514 0
Approval date [2] 2514 0
Ethics approval number [2] 2514 0
Ethics committee name [3] 2515 0
Mercy Health and Aged Care,
Mercy Hospital for Women.
Ethics committee address [3] 2515 0
Ethics committee country [3] 2515 0
Australia
Date submitted for ethics approval [3] 2515 0
Approval date [3] 2515 0
Ethics approval number [3] 2515 0
R06/04 for both original approval and up-date.

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

Contacts
Principal investigator
Name 35834 0
Address 35834 0
Country 35834 0
Phone 35834 0
Fax 35834 0
Email 35834 0
Contact person for public queries
Name 10062 0
Dr Lawrence Bartak
Address 10062 0
Krongold Centre
Department of Education
Monash University
Wellington Road
Clayton VIC 3168
Country 10062 0
Australia
Phone 10062 0
+61 425717960
Fax 10062 0
Email 10062 0
lawrence.bartak@education.monash.edu.au
Contact person for scientific queries
Name 990 0
Primrose White
Address 990 0
13 Manorwood Place
Mitcham VIC 3132
Country 990 0
Australia
Phone 990 0
+61 3 98746762
Fax 990 0
Email 990 0
primrose.white@education.monash.edu.au

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.