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| Name | Class |
|---|---|
| Massage Therapy Foundation | OTHER |
| University of Western Sydney | OTHER |
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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:
Participants will [ If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].](streamdown:incomplete-link)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massage | Experimental | Women will receive four 60 minute massage consultations within a four-month period at intervals of their choosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Massage | Other | Individualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Participants will be excluded if they are unable to receive the study treatments in the allocated time frame.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Fogarty, PhD | Western Sydney University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Sydney University | Sydney | New South Wales | 2000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41501746 | Derived | Fogarty S, Heazell AEP, Munk N, Hay P. Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): feasibility and acceptability findings from a convergent parallel mixed-methods single-arm trial. BMC Complement Med Ther. 2026 Jan 8;26(1):45. doi: 10.1186/s12906-026-05244-2. |
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All individual participant data that underlie results in a publication. The stored data available for re-use will not have information in it that makes participants identifiable.
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Data collected from this study will be made available online and world-wide in perpetuity.
None, it will be open access.
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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A convergent parallel mixed-methods, single arm repeated measures pilot trial design
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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 |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |