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

Status Active, not recruiting

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].

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pregnancy Loss
• Pregnancy Related
• Stillbirth

• NCT number: NCT05636553
• Study type: Interventional
• Source: Fogarty Sarah
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2023
• Completion date: December 2024