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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05636553


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05636553
Ethics application status
Date submitted
11/11/2022
Date registered
5/12/2022
Date last updated
13/05/2024

Titles & IDs
Public title
Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
Scientific title
Mixed-methods Single-arm Study Evaluating the Feasibility of Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
Secondary ID [1] 0 0
20705.66430
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related 0 0
Pregnancy Loss 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Massage

Experimental: Massage - Women will receive four 60 minute massage consultations within a four-month period at intervals of their choosing.


Other interventions: Massage
Individualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the feasibility of massage as an adjunct approach to care for pregnant women who have experienced a stillbirth as assessed using a mixed methods narrative and joint display approach
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [2] 0 0
Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure
Timepoint [4] 0 0
Through study completion, an average of 1 year
Secondary outcome [5] 0 0
Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale
Timepoint [5] 0 0
Through study completion, an average of 1 year
Secondary outcome [6] 0 0
Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure
Timepoint [6] 0 0
Through study completion, an average of 1 year
Secondary outcome [7] 0 0
Recruitment rates (proportion of people randomised/proportion of people eligible)
Timepoint [7] 0 0
Through study completion, an average of 1 year
Secondary outcome [8] 0 0
Retention rates (proportion of people providing the outcomes of interest/proportion randomised)
Timepoint [8] 0 0
Through study completion, an average of 1 year
Secondary outcome [9] 0 0
Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)
Timepoint [9] 0 0
Through study completion, an average of 1 year
Secondary outcome [10] 0 0
Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview
Timepoint [10] 0 0
Through study completion, an average of 1 year
Secondary outcome [11] 0 0
Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments
Timepoint [11] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
- Pregnant women 18 years of age or greater who have experienced a stillbirth (pregnancy
loss from 20 weeks gestation) in a previous pregnancy.

- Participants who had a medial termination from 20-weeks' gestation will be included in
the study.

- Participants must be able to attend one of the study pregnancy massage therapists'
clinics located within Australia.

- Having had previous massage experience is not an enrolment criterion, it is just not
an exclusion criterion.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants will be excluded if they are unable to receive the study treatments in the
allocated time frame.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Western Sydney University - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Fogarty Sarah
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Massage Therapy Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Western Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this mixed-methods single-arm study is to measure the feasibility of massage as
an adjunct approach to care for pregnant women who have experienced a stillbirth. In order to
provide pilot data, this intervention study will:

1. Determine the feasibility and acceptability of the massage intervention and optimize the
timing and outcome measures,

2. Provide data for future use in an individual participant data systematic review, and

3. Evaluate experiences of women undertaking the intervention

Participants will [ If there is a comparison group: Researchers will compare [insert groups]
to see if [insert effects].
Trial website
https://clinicaltrials.gov/ct2/show/NCT05636553
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah Fogarty, PhD
Address 0 0
Western Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries




Additional trial details provided through ANZCTR
Accrual to date
21
Recruiting in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Funding & Sponsors
Primary sponsor
Charities/Societies/Foundations
Primary sponsor name
Massage Therapy Foundation
Primary sponsor address
500 Davis Street, Suite 950
Evanston, IL 60201
Primary sponsor country
United States of America
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 59
Western Sydney University Human Research Ethics Committee
Address [1] 59
Principal Investigator Sarah Fogarty Western Sydney University PO Box 8218 Ferntree Gully VIC 3156
Country [1] 59
Australia
Date submitted for ethics approval [1] 59
27/10/2022
Approval date [1] 59
07/02/2023
Ethics approval number [1] 59
H15261
 
Public notes
Principal Investigator contact email is s.fogarty@westernsydney.edu.au

Contacts
Principal investigator
Title 365 0
Dr
Name 365 0
Sarah Fogarty
Address 365 0
Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
Country 365 0
Australia
Phone 365 0
+61405078914
Fax 365 0
Email 365 0
s.fogarty@westernsydney.edu.au
Contact person for public queries
Title 366 0
Dr
Name 366 0
Sarah Fogarty
Address 366 0
Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
Country 366 0
Australia
Phone 366 0
+61405078914
Fax 366 0
Email 366 0
s.fogarty@westernsydney.edu.au or pregnancyafterstillbirth@gmail.com
Contact person for scientific queries
Title 367 0
Dr
Name 367 0
Sarah Fogarty
Address 367 0
Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
Country 367 0
Australia
Phone 367 0
+61405078914
Fax 367 0
Email 367 0
s.fogarty@westernsydney.edu.au