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

NCT ID: NCT05636553

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-12-31

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.

Conditions

Pregnancy Related; Pregnancy Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Massage

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

Group Type: EXPERIMENTAL

Massage

Intervention Type: OTHER

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

Interventions

Massage

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massage Therapy Foundation

OTHER

Sponsor Role: collaborator

University of Western Sydney

OTHER

Sponsor Role: collaborator

Fogarty Sarah

OTHER

Sponsor Role: lead

Responsible Party

Sarah Fogarty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Fogarty, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Sydney University

Locations

Western Sydney University

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

20705.66430

Identifier Type: -

Identifier Source: org_study_id