Pregnancy RelatedNCT05636553
Massage as an Adjunct Approach to Care for Pregnant Women Who Have Experienced a Stillbirth
A study testing Massage in people with Pregnancy Related and Pregnancy Loss, run by Fogarty Sarah at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pregnancy Loss
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they are unable to receive the study treatments in the allocated time frame.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- Determine the feasibility and acceptability of the massage intervention and optimize the timing and outcome measures,
- Provide data for future use in an individual participant data systematic review, and
- 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].
Read the 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
- Being tested
- Massage
- Keywords
- pregnancy, massage, pregnancy after stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Individualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Women will receive four 60 minute massage consultations within a four-month period at intervals of their choosing. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (11)
Changes in worry from baseline to a week post treatment interventions using the self-reported Cambridge Worry Score
Higher scores indicate greater worry. Scores from 0-85
Measured: 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
Higher scores indicate greater anxiety. Min score is 0 and max is 21.
Measured: 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
Higher scale scores correspond to a more frequent use of the specific coping style.
Measured: 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
Higher scores indicate greater confidence in carrying out the behaviors to promote health. Total score range is from 29 to 145.
Measured: 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
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.
Measured: Through study completion, an average of 1 year
Assessing empathy in the context of the therapeutic relationship via the Consultation and Relational Empathy patient-reported experience measure
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.
Measured: Through study completion, an average of 1 year
Recruitment rates (proportion of people randomised/proportion of people eligible)
Presented as numbers and percentages
Measured: Through study completion, an average of 1 year
Retention rates (proportion of people providing the outcomes of interest/proportion randomised)
Presented as numbers and percentages
Measured: Through study completion, an average of 1 year
Compliance with completing the validated outcome measures (number of validated measures asked to complete/number of validated measures completed)
Presented as numbers and percentages
Measured: Through study completion, an average of 1 year
Elucidating participants' experience of massage in a pregnancy after a stillbirth using a qualitative in-depth interview
Thematic inductive analysis will be used to analyse the qualitative data
Measured: Through study completion, an average of 1 year
Optimization of massage timing to determine when treatments are likely to be of most value presented as a average of time between treatments
Presented as means and ranges of times between treatments
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start7 Feb 2023
- Primary completion1 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A convergent parallel mixed-methods, single arm repeated measures pilot trial design
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fogarty Sarah
- Sponsor type
- University, hospital or other
- Collaborators
- Massage Therapy Foundation, University of Western Sydney
- Responsible party
- Principal investigator, Sarah Fogarty, Fogarty Sarah
- Investigators
- Sarah Fogarty, PhD, Principal investigator, Western Sydney University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636553
- Sponsor's protocol ID
- 20705.66430
- Status last verified
- Feb 2025
- First submitted
- 11 Nov 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication. The stored data available for re-use will not have information in it that makes participants identifiable.
Publications
Fogarty S, Heazell AEP, Munk N, Hay P. Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): feasibility and acceptability findings from a convergent parallel mixed-methods single-arm trial. BMC Complement Med Ther. 2026 Jan 8;26(1):45. doi: 10.1186/s12906-026-05244-2.
PubMed 41501746
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05636553
- Acronym / sponsor ID
- 20705.66430
- Conditions
- Pregnancy Related, Pregnancy Loss
- Keywords
- pregnancy, massage, pregnancy after stillbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fogarty SarahUniversity, hospital or other
- Collaborators
- Massage Therapy Foundation, University of Western Sydney
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the feasibility and acceptability of the massage intervention and optimize the timing and outcome measures,
- Provide data for future use in an individual participant data systematic review, and
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A convergent parallel mixed-methods, single arm repeated measures pilot trial design
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: MassageWomen will receive four 60 minute massage consultations within a four-month period at intervals of their choosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded if they are unable to receive the study treatments in the allocated time frame.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageIndividualised treatment using massage techniques such as longitudinal gliding, transverse gliding, digital ischemic pressure, transverse frictions, and transverse gliding. | Other | Massage |
Primary outcome
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.
11 secondary outcomes
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
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
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
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
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
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
Recruitment rates (proportion of people randomised/proportion of people eligible)
Time frame: Through study completion, an average of 1 year
Retention rates (proportion of people providing the outcomes of interest/proportion randomised)
Time frame: Through study completion, an average of 1 year
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 41501746Fogarty S, Heazell AEP, Munk N, Hay P. Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): feasibility and acceptability findings from a convergent parallel mixed-methods single-arm trial. BMC Complement Med Ther. 2026 Jan 8;26(1):45. doi: 10.1186/s12906-026-05244-2.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication. The stored data available for re-use will not have information in it that makes participants identifiable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Fogarty, PhD principal investigator
Western Sydney University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Pregnancy Related and Pregnancy Loss, run by Fogarty Sarah at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.