Pregnancy Related Clinical Trial
Official 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
Verified date | May 2024 |
Source | Fogarty Sarah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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].
Status | Active, not recruiting |
Enrollment | 76 |
Est. completion date | December 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Western Sydney University | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Fogarty Sarah | Massage Therapy Foundation, University of Western Sydney |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 1 year | |
Secondary | Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score | Higher scores indicate greater worry. Scores from 0-85 | Through study completion, an average of 1 year | |
Secondary | Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7 | Higher scores indicate greater anxiety. Min score is 0 and max is 21. | Through study completion, an average of 1 year | |
Secondary | Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory | Higher scale scores correspond to a more frequent use of the specific coping style. | Through study completion, an average of 1 year | |
Secondary | Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure | Higher scores indicate greater confidence in carrying out the behaviors to promote health. Total score range is from 29 to 145. | Through study completion, an average of 1 year | |
Secondary | Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale | 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. | Through study completion, an average of 1 year | |
Secondary | Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure | 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. | Through study completion, an average of 1 year | |
Secondary | Recruitment rates (proportion of people randomised/proportion of people eligible) | Presented as numbers and percentages | Through study completion, an average of 1 year | |
Secondary | Retention rates (proportion of people providing the outcomes of interest/proportion randomised) | Presented as numbers and percentages | Through study completion, an average of 1 year | |
Secondary | Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed) | Presented as numbers and percentages | Through study completion, an average of 1 year | |
Secondary | Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview | Thematic inductive analysis will be used to analyse the qualitative data | Through study completion, an average of 1 year | |
Secondary | Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments | Presented as means and ranges of times between treatments | Through study completion, an average of 1 year |
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