Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000447257
Ethics application status
Approved
Date submitted
10/03/2018
Date registered
28/03/2018
Date last updated
11/03/2020
Date data sharing statement initially provided
11/03/2020
Date results information initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Massage and Maternal Anxiety (MAMA) pilot study.
Scientific title
Massage and Maternal Anxiety (MAMA) pilot study; The feasibility of partner-delivered massage for maternal mental health during pregnancy
Secondary ID [1] 294296 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal anxiety 307001 0
Condition category
Condition code
Mental Health 306095 306095 0 0
Anxiety
Reproductive Health and Childbirth 306170 306170 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this feasibility study is to explore the potential of partner delivered relaxation massage maternal anxiety during pregnancy.
Partner-delivered relaxation massage program
Women allocated to this program, will be invited with their partner to attend a 2 hour workshop about mental health and relaxation massage techniques. The workshop will take place at Monash University’s Peninsula campus and be conducted by an experienced midwife and a qualified massage therapist. Following the massage workshop, women and their partners will be asked to undertake twice-weekly 20 minute relaxation massages at home until birth. Women will be given an instructional DVD and a manual about the massage techniques. Women will be invited to attend refresher training as required. Following the workshop, women will be asked to complete a short monthly online questionnaire which will assess anxiety levels. Women will also be asked to complete a weekly online log book, and participate in a face-to-face or telephone interview 4-6 weeks after the birth of their baby.


Intervention code [1] 300596 0
Treatment: Other
Comparator / control treatment
Comparator treatment: Self-directed stress management program:
Women allocated to this program, will be invited to attend a 2 hour midwife-facilitated workshop where they will learn about mental health during pregnancy, and lifestyle strategies to manage anxiety and stress. The workshop will take place at Monash University’s Peninsula campus. Their partner may also participate in this workshop, however their participation is not mandatory. Following the workshop women will be able to use any stress reduction activity they like, and complete a short monthly online questionnaire which will assess anxiety levels.
Control group
Active

Outcomes
Primary outcome [1] 305126 0
Feasibility:
Feasibility of the recruitment and retention strategies will be measured by the rate of participants who complete the online questionnaire.
Timepoint [1] 305126 0
4 week intervals for the duration of study and 4-6 weeks following birth
Primary outcome [2] 305278 0
Acceptability
Acceptability will be measured by compliance with the massage instructions, using a weekly log and an interview with the woman/partner dyad 4-6 weeks following birth.
Timepoint [2] 305278 0
4 week intervals for the duration of study and 4-6 weeks following birth
Secondary outcome [1] 344267 0
Perinatal anxiety as assessed via the State domain of State-Trait Anxiety Inventory (STAI-S) (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983).
Timepoint [1] 344267 0
4 week intervals for the duration of study and 4-6 weeks following birth
Secondary outcome [2] 344268 0
Stress as assessed via the Perceived Stress Scale (PSS) (Cohen, Kamarck, & Mermelstein, 1983).
Timepoint [2] 344268 0
4 week intervals for the duration of study and 4-6 weeks following birth
Secondary outcome [3] 344270 0
Discomforts of pregnancy assessed via self-report of conditions in their monthly questionnaire.
Timepoint [3] 344270 0
4 week intervals for the duration of study and 4-6 weeks following birth
Secondary outcome [4] 344271 0
Adverse birth outcomes assessed via Birth Outcome Summary (BOS) data
Timepoint [4] 344271 0
4-6 weeks following birth

Eligibility
Key inclusion criteria
Pregnant women who have moderate anxiety as measured by the Spielberger State Trait Anxiety Index (STAI); a low risk pregnancy: are between 24 and 32 gestation at the start of the intervention; aged 18 years or older and able to read and speak English; who commit to attending the workshop with a partner, and if allocated to the massage intervention group, commit undertaking home practice of relaxation massage at least twice a week for the remainder of their pregnancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women: History of a major mental illness including psychotic disorders, post-traumatic stress disorder and substance abuse disorders; high risk pregnancy or known obstetric complications, a score 13 or higher on the Edinburgh Postnatal Depression Scale (Cohen et al., 1983) or who answer in the affirmative to question 10 indicating that they have considered self-harm (referral to primary pregnancy care provider or GP). Women with touch adverse, fibromyalgia or other pre-pregnancy pain and/or touch perception/sensory conditions will also be excluded. If a woman develops a complication after recruitment, she will be advised to withdraw from the intervention arm of the study.
Partners (identified by the woman): unable to attend the workshop or to commit to massage practice.

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 concealment using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study to assess acceptability and feasibility

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2018
Actual
27/08/2018
Date of last participant enrolment
Anticipated
1/09/2018
Actual
21/11/2018
Date of last data collection
Anticipated
1/02/2019
Actual
3/06/2019
Sample size
Target
40
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10369 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 22040 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 298944 0
University
Name [1] 298944 0
Monash University Nursing & Midwifery Strategic Grant Scheme
Country [1] 298944 0
Australia
Primary sponsor type
University
Name
Moansh University Nursing and Midwifery
Address
Monash University(Peninsula Campus)
Nursing & Midwifery
Moorooduc Hwy
Frankston 3199
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 298157 0
None
Name [1] 298157 0
Address [1] 298157 0
Country [1] 298157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299880 0
Monash University Human Ethics Committee
Ethics committee address [1] 299880 0
Monash University
Scenic Blvd,
Clayton
VIC 3800
Australia
Ethics committee country [1] 299880 0
Australia
Date submitted for ethics approval [1] 299880 0
10/10/2017
Approval date [1] 299880 0
11/12/2017
Ethics approval number [1] 299880 0
11281
Ethics committee name [2] 299982 0
Peninsula Health
Ethics committee address [2] 299982 0
Hastings road
Frankston, 3177
Victoria
Ethics committee country [2] 299982 0
Australia
Date submitted for ethics approval [2] 299982 0
21/03/2018
Approval date [2] 299982 0
Ethics approval number [2] 299982 0

Summary
Brief summary
A significant proportion of women struggle with anxiety and stress during pregnancy, and this can affect the health of both the mother and her baby. Relaxation interventions might be helpful, however the evidence is not conclusive. The purpose of this feasibility study is to explore the potential of two programs aimed at helping to decrease anxiety during pregnancy: 1. a partner delivered relaxation massage program; and 2. a self-directed stress management program. Pregnant women will be invited to participate in the study and randomly assigned to one of the two programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81850 0
Dr Helen Hall
Address 81850 0
Monash University (Peninsula Campus)
Nursing & Midwifery
McMahons Road
Frankston 3199
Victoria
Australia
Country 81850 0
Australia
Phone 81850 0
61 3 99044120
Fax 81850 0
Email 81850 0
Helen.Hall@monash.edu
Contact person for public queries
Name 81851 0
Dr Helen Hall
Address 81851 0
Monash University (Peninsula Campus)
Nursing & Midwifery
McMahons Road
Frankston 3199
Victoria
Australia
Country 81851 0
Australia
Phone 81851 0
61 3 99044120
Fax 81851 0
Email 81851 0
Helen.Hall@monash.edu
Contact person for scientific queries
Name 81852 0
Dr Helen Hall
Address 81852 0
Monash University (Peninsula Campus)
Nursing & Midwifery
McMahons Road
Frankston 3199
Victoria
Australia
Country 81852 0
Australia
Phone 81852 0
61 3 99044120
Fax 81852 0
Email 81852 0
Helen.Hall@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 374698-(Uploaded-10-03-2020-17-56-31)-Basic results summary.docx
Plain language summaryNo 17 women who consented to participate did not atte... [More Details]

Documents added automatically
No additional documents have been identified.