Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): a convergent parallel mixed-methods single-arm feasibility trial protocol

Abstract

Abstract Background Women experiencing pregnancy after stillbirth experience high levels of anxiety, fear and depression. Standard antenatal care may be emotionally unsuitable for many women at this time, and there is a lack of evidence on what interventions or approaches to care might benefit these women. Therapeutic massage may assist women after stillbirth by decreasing anxiety, worry and stress. Objective This paper outlines the objectives, methodology, outcome and assessment measures for the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) feasibility trial which evaluates massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth. It also outlines data collection timing and considerations for analysing the data. Methods HOPES will use a convergent parallel mixed-methods, single-arm repeated measures trial design in trained massage therapists’ private clinics across Australia. HOPES aims to recruit 75 individuals pregnant after a previous stillbirth. The intervention is massage therapy treatments, and participants will receive up to five massages within a 4-month period at intervals of their choosing. Primary quantitative outcomes are the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collection of measures for anxiety, worry, stress and self-management. A thematic analysis of women’s experiences undertaking the intervention will also be conducted. A narrative and joint display approach to integrate mixed-methods data is planned. Discussion The HOPES study will determine the feasibility and preliminary evidence for massage therapy as an intervention to support women who are pregnant after a stillbirth. Trial registration. ClinicalTrials.gov NCT05636553. Registered on December 3, 2022, and the trial is ongoing.