Mixed-methods Single-arm Study Evaluating the Feasibility of Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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:
- Determine the feasibility and acceptability of the massage intervention and optimize the timing and outcome measures,
- Provide data for future use in an individual participant data systematic review, and
- 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].
Detailed Description
Research shows that women experiencing pregnancy after stillbirth experience anxiety, fear, and depression. There is a limited evidence of adjunct emotional care approaches for women to utilise to help manage pregnancy after a stillbirth. Massage may assist women who are pregnant after a stillbirth via decreasing anxiety, worry and stress.
Aim: To measure the feasibility of massage as an adjunct approach to care for pregnant women who have experienced a stillbirth.
Design: This study will use a convergent parallel mixed-methods, single arm repeated measures pilot trial design.
Setting: Massage therapists' private clinics across Australia. Participants: Subjects will include 75 pregnant women who have experienced a stillbirth in a previous pregnancy.
Intervention: Women will receive four massages within a four-month period at intervals of their choosing. The massage treatments are based on a vulnerability-to-stress concept which acknowledges the impact of stress on a pregnant woman based on a biopsychosocial model.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Time Frame: 1 year
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.
Secondary Outcomes
- Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale(Through study completion, an average of 1 year)
- Recruitment rates (proportion of people randomised/proportion of people eligible)(Through study completion, an average of 1 year)
- Retention rates (proportion of people providing the outcomes of interest/proportion randomised)(Through study completion, an average of 1 year)
- Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview(Through study completion, an average of 1 year)
- Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments(Through study completion, an average of 1 year)
- Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score(Through study completion, an average of 1 year)
- Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory(Through study completion, an average of 1 year)
- Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7(Through study completion, an average of 1 year)
- Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure(Through study completion, an average of 1 year)
- Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure(Through study completion, an average of 1 year)
- Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)(Through study completion, an average of 1 year)
Investigators
Sarah Fogarty
Principal Investigator
Fogarty Sarah