Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 registered on ANZCTR


Registration number
ACTRN12609000483257
Ethics application status
Not yet submitted
Date submitted
25/02/2009
Date registered
18/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxytocin as an adjunct to interaction coaching and baby massage to improve bonding in the early postpartum.
Scientific title
A study examining the effects of placebo/oxytocin and baby massage and interaction coaching/information support on early postpartum mothers bonding experiences.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mothers with some degree of postnatal depression who report bonding difficulties 4382 0
Condition category
Condition code
Mental Health 4629 4629 0 0
Other mental health disorders
Reproductive Health and Childbirth 237359 237359 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mothers receive oxytocin (prepared by chemists) via a nasal spray(24IU) once at the beginning of the session, over two consecutive days. Participants who are given oxytocin are randomly allocated to either interaction coaching/baby massage or informational videos. The videos are of 30 minutes duration and are presented immediately following delivery of the nasal spray.
Intervention code [1] 4114 0
Treatment: Drugs
Comparator / control treatment
Mothers receive placebo (contains the same ingredients as the oxytocin mixture but without the active ingredient) via a nasal spray(24IU) once at the beginning of the session, over two consecutive days. Participants who are given placebo are randomly allocated to either interaction coaching/baby massage or informational videos. The videos are of 30 minutes duration and are presented immediately following delivery of the nasal spray.
Control group
Placebo

Outcomes
Primary outcome [1] 5499 0
Video observation of mothers interacting with their infants is coded for bonding behaviours by the researchers.
Timepoint [1] 5499 0
End of trial
Secondary outcome [1] 9261 0
Mother's self reported bonding with their infants (questionnaires)
Timepoint [1] 9261 0
End of trial

Eligibility
Key inclusion criteria
Primiparous mothers who report some degree of depression and report and impaired bond with their infants
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, epliepsy, psychotic symptoms, hypotension, heart condition, allergy to preservatives. Infant birth defects.

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)
Allocation schedule is held offsite and drugs are in numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation from a randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Interaction coaching and massage training is single blind for the participant but not for the administer of the treatment. Assessment of outcomes is blinded.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4557 0
University
Name [1] 4557 0
University of New South Wales (UNSW)
Country [1] 4557 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Randwick NSW 2052
Country
Australia
Secondary sponsor category [1] 4113 0
None
Name [1] 4113 0
Address [1] 4113 0
Country [1] 4113 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6607 0
UNSW Human Research Ethics Committee (HREC)
Ethics committee address [1] 6607 0
Ethics committee country [1] 6607 0
Australia
Date submitted for ethics approval [1] 6607 0
03/03/2009
Approval date [1] 6607 0
Ethics approval number [1] 6607 0

Summary
Brief summary
A between subjects randomized controlled trial is being used to assess the efficacy of oxytocin delivered alongside interaction coaching and massage to improve maternal behaviour towards the infant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29323 0
Address 29323 0
Country 29323 0
Phone 29323 0
Fax 29323 0
Email 29323 0
Contact person for public queries
Name 12570 0
Rebecca McErlean
Address 12570 0
School of Psychology
University of New South Wales
Kensington, 2052
Country 12570 0
Australia
Phone 12570 0
+61 (0) 2 9385 3828
Fax 12570 0
Email 12570 0
[email protected]
Contact person for scientific queries
Name 3498 0
Rebecca McErlean
Address 3498 0
School of Psychology
University of New South Wales
Kensington, 2052
Country 3498 0
Australia
Phone 3498 0
+61 (0) 2 9385 3828
Fax 3498 0
Email 3498 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.