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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
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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
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Secondary ID [1]
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20705.66430
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related
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Pregnancy Loss
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Condition category
Condition code
Reproductive Health and Childbirth
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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The quantitative and qualitative findings will be integrated using a narrative reporting approach and fit of data integration (coherence of the quantitative and qualitative findings) will be reported.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score
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Assessment method [1]
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Higher scores indicate greater worry. Scores from 0-85
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Timepoint [1]
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Through study completion, an average of 1 year
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Secondary outcome [2]
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Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7
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Assessment method [2]
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Higher scores indicate greater anxiety. Min score is 0 and max is 21.
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Timepoint [2]
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Through study completion, an average of 1 year
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Secondary outcome [3]
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Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory
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Assessment method [3]
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Higher scale scores correspond to a more frequent use of the specific coping style.
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Timepoint [3]
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Through study completion, an average of 1 year
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Secondary outcome [4]
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Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure
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Assessment method [4]
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Higher scores indicate greater confidence in carrying out the behaviors to promote health. Total score range is from 29 to 145.
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Timepoint [4]
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Through study completion, an average of 1 year
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Secondary outcome [5]
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Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale
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Assessment method [5]
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Higher scores indicating higher perceived stress. The total score range is from zero to 40 with a scores ranging from 0-13 considered low stress, 14-26 moderate stress and 27-40 high stress.
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Timepoint [5]
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Through study completion, an average of 1 year
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Secondary outcome [6]
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Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure
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Assessment method [6]
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This scale has 10 items that measures patients' perceptions of relational empathy in the consultation. The total score range is from 10 to 40 with higher scores indicating greater perceived relational empathy.
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Timepoint [6]
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Through study completion, an average of 1 year
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Secondary outcome [7]
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Recruitment rates (proportion of people randomised/proportion of people eligible)
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Assessment method [7]
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Presented as numbers and percentages
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Timepoint [7]
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Through study completion, an average of 1 year
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Secondary outcome [8]
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Retention rates (proportion of people providing the outcomes of interest/proportion randomised)
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Assessment method [8]
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Presented as numbers and percentages
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Timepoint [8]
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Through study completion, an average of 1 year
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Secondary outcome [9]
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Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)
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Assessment method [9]
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Presented as numbers and percentages
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Timepoint [9]
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Through study completion, an average of 1 year
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Secondary outcome [10]
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Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview
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Assessment method [10]
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Thematic inductive analysis will be used to analyse the qualitative data
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Timepoint [10]
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Through study completion, an average of 1 year
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Secondary outcome [11]
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Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments
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Assessment method [11]
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Presented as means and ranges of times between treatments
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Timepoint [11]
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Through study completion, an average of 1 year
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Participants will be excluded if they are unable to receive the study treatments in the
allocated time frame.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Western Sydney University - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Fogarty Sarah
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Massage Therapy Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Western Sydney
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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].
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05636553
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sarah Fogarty, PhD
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Address
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Western Sydney University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05636553
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]
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Principal Investigator Sarah Fogarty Western Sydney University PO Box 8218 Ferntree Gully VIC 3156
Country [1]
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Australia
Date submitted for ethics approval [1]
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27/10/2022
Approval date [1]
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07/02/2023
Ethics approval number [1]
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H15261
Public notes
Principal Investigator contact email is
[email protected]
Contacts
Principal investigator
Title
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Dr
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Name
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Sarah Fogarty
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Address
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Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
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Country
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Australia
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Phone
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+61405078914
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Dr
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Name
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Sarah Fogarty
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Address
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Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
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Country
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Australia
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Phone
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+61405078914
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Fax
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Email
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[email protected]
or
[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Sarah Fogarty
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Address
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Western Sydney University C/O PO Box 8218 Ferntree Gully VIC 3156
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Country
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Australia
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Phone
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+61405078914
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Fax
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Email
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[email protected]
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