Clinical trial NCT05636553: Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Pregnancy Loss
Keywords: pregnancy
massage
pregnancy after stillbirth
Lead sponsor: Fogarty Sarah
Sponsor class: OTHER
Collaborators: name: Massage Therapy Foundation
name: University of Western Sydney
First posted: 2022-12-05
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A convergent parallel mixed-methods, single arm repeated measures pilot trial design
Primary purpose: SUPPORTIVE_CARE

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:

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 \[insert effects\].

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score
timeFrame: Through study completion, an average of 1 year
measure: Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7
timeFrame: Through study completion, an average of 1 year
measure: Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory
timeFrame: Through study completion, an average of 1 year
measure: Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure
timeFrame: Through study completion, an average of 1 year
measure: Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale
timeFrame: Through study completion, an average of 1 year
measure: Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure
timeFrame: Through study completion, an average of 1 year
measure: Recruitment rates (proportion of people randomised/proportion of people eligible)
timeFrame: Through study completion, an average of 1 year
measure: Retention rates (proportion of people providing the outcomes of interest/proportion randomised)
timeFrame: Through study completion, an average of 1 year
measure: Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)
timeFrame: Through study completion, an average of 1 year
measure: Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview
timeFrame: Through study completion, an average of 1 year
measure: Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Western Sydney University
state: New South Wales
Study officials:
affiliation: Western Sydney University
name: Sarah Fogarty, PhD
role: PRINCIPAL_INVESTIGATOR
References: