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

NCT05636553 | Completed

• 1 other identifier: 20705.66430
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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. 1.Determine the feasibility and acceptability of the massage intervention and optimize the timing and outcome measures,
2. 2.Provide data for future use in an individual participant data systematic review, and
3. 3.Evaluate experiences of women undertaking the intervention

Conditions

Pregnancy Related; Pregnancy Loss

Keywords

pregnancy; massage; pregnancy after stillbirth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 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 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 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

• 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

Study Arms (1)

Massage

EXPERIMENTAL

Women will receive four 60 minute massage consultations within a four-month period at intervals of their choosing.

Other: Massage

Interventions

Massage OTHER

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

Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Participants will be excluded if they are unable to receive the study treatments in the allocated time frame.

Sponsors & Collaborators

• Fogarty Sarah: lead
• Massage Therapy Foundation: collaborator
• University of Western Sydney: collaborator

Study Sites (1)

Western Sydney University

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sarah Fogarty, PhD

  Western Sydney University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A convergent parallel mixed-methods, single arm repeated measures pilot trial design

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 5, 2022
• Study Start: February 7, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data collected from this study will be made available online and world-wide in perpetuity.
• Access Criteria: None, it will be open access.

Locations

AU (1)