Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth

Study Overview
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Brief Summary
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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
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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. The massage protocol allows treatment to be individualised to meet the needs of the participant. Main outcome measures: The primary outcomes are a) feasibility, b) acceptability and experience of the massage intervention and c) optimization - i.e., capacity of the outcome measures to capture the impact of the intervention received, and to determine when treatments are likely to be of most value. Analysis Plan: Data will be analysed to meet the study objectives of determining feasibility, acceptability, optimising timing, and outcome measures, and to obtain preliminary data to understand the effects and value of massage on women who are pregnant after a stillbirth. Significance of the work: Standard antenatal care is emotionally unsuitable for many women in pregnancies following a stillbirth and there is a lack of direct evidence on what interventions or approaches to care might benefit these women. Our proposed research will begin to address this lack of direct evidence.

Official Title
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Mixed-methods Single-arm Study Evaluating the Feasibility of Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth

Conditions
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Pregnancy Related, Pregnancy Loss

Intervention / Treatment
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* Other: Massage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A convergent parallel mixed-methods, single arm repeated measures pilot trial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage<br>Women will receive four 60 minute massage consultations within a four-month period at intervals of their choosing. | Other: Massage<br>* Individualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Recruitment rates (proportion of people randomised/proportion of people eligible) | Presented as numbers and percentages | Through study completion, an average of 1 year | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, massage, pregnancy after stillbirth