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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636553
• Other study ID #: 20705.66430
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Fogarty Sarah
• Contact: Sarah Fogarty, PhD
• Phone: +61 405078914
• Email: pregnancyafterstillbirth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2024
• Est. primary completion date: January 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.

Related Conditions & MeSH terms

• Pregnancy Loss
• Pregnancy Related
• Stillbirth

Intervention

Other:
• Massage
Individualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding.

Locations

Country	Name	City	State
Australia	Western Sydney University	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Fogarty Sarah	Massage Therapy Foundation, University of Western Sydney

Country where clinical trial is conducted

Australia, 

Outcome

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