Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth (NCT05636553) | Clinical Trial Compass
CompletedNot Applicable
Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
Australia76 participantsStarted 2023-02-07
Plain-language 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 \[insert effects\].
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria:
\- Participants will be excluded if they are unable to receive the study treatments in the allocated time frame.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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