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Completed

NCT Number: NCT05636553

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

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].

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Key information

Conditions

Pregnancy Related Pregnancy Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Sydney University

Sydney, New South Wales, 2000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage

Other

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

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

    Time frame: 1 year

    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.

Secondary outcomes

  1. Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score

    Time frame: Through study completion, an average of 1 year

    Higher scores indicate greater worry. Scores from 0-85

  2. Changes in maternal anxiety symptoms from baseline to a week post treatment interventions using the Generalized Anxiety Disorder Assessment 7

    Time frame: Through study completion, an average of 1 year

    Higher scores indicate greater anxiety. Min score is 0 and max is 21.

  3. Changes in coping from baseline to a week post treatment interventions using the self-reported Revised Prenatal Coping Inventory

    Time frame: Through study completion, an average of 1 year

    Higher scale scores correspond to a more frequent use of the specific coping style.

  4. Changes in self-efficacy from baseline to a week post treatment interventions using the Strategies Used by People to Promote Health measure

    Time frame: Through study completion, an average of 1 year

    Higher scores indicate greater confidence in carrying out the behaviors to promote health. Total score range is from 29 to 145.

  5. Changes in maternal stress symptoms from baseline to a week post treatment interventions using the Perceived Stress Scale

    Time frame: Through study completion, an average of 1 year

    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.

  6. Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure

    Time frame: Through study completion, an average of 1 year

    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.

  7. Recruitment rates (proportion of people randomised/proportion of people eligible)

    Time frame: Through study completion, an average of 1 year

    Presented as numbers and percentages

  8. Retention rates (proportion of people providing the outcomes of interest/proportion randomised)

    Time frame: Through study completion, an average of 1 year

    Presented as numbers and percentages

  9. Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)

    Time frame: Through study completion, an average of 1 year

    Presented as numbers and percentages

  10. Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview

    Time frame: Through study completion, an average of 1 year

    Thematic inductive analysis will be used to analyse the qualitative data

  11. Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments

    Time frame: Through study completion, an average of 1 year

    Presented as means and ranges of times between treatments

Sponsors and collaborators

Lead sponsor

Fogarty Sarah

Other

Collaborators

  • Massage Therapy Foundation
  • University of Western Sydney

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2022
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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