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.

backgroundWomen experiencing pregnancy after stillbirth or perinatal death experience high levels of anxiety, fear, and depression. Standard antenatal care may be emotionally challenging for women at this time and there is a lack of evidence on which care interventions or approaches may be beneficial. Evidence is growing that therapeutic massage may assist these women by providing adjunct support during a pregnancy after a loss.

objectiveThis paper reports feasibility and acceptability of the Helping suppOrt individuals Pregnant after Experiencing a Stillbirth (HOPES) trial which evaluated therapeutic massage as an adjunct approach to care for pregnant women who have experienced a prior stillbirth or termination for medical reasons from 20 weeks of gestation.

methodsHOPES used a convergent parallel mixed-methods, single arm repeated measures trial design with massage provided by trained massage therapists in their private clinics across Australia. The intervention was up to five massage therapy treatments during the pregnancy at intervals of participant choosing. Primary outcomes were the feasibility and acceptability of the massage intervention. Secondary outcomes include determining the optimal timing of massage therapy delivery and the collections of measures for anxiety, worry, stress, and self-management. Data were analysed using descriptive statistics for participants’ demographic and clinical characteristics. Appropriate matched tests were used to evaluate summary statistics of the observational clinical treatment data (e.g., worry, anxiety, etc.) to determine whether there were significant differences between baseline and post final treatment scores.

resultsHOPES recruited 76 individuals pregnant after a previous stillbirth or termination for medical reasons (TFMR) after 20 weeks’ gestation; 70 participants completed the study (attrition = 8.6%). The average number of treatments participants accessed was 4.3. The study participants found the study intervention acceptable and supportive and experienced the study itself as acceptable. Exploratory quantitative analysis and qualitative findings signaled potential benefit from the study intervention. A portion of the domains to assess feasibility, that were able to be objectively quantified, were used as success criteria for progression to a larger study and all of these criteria were all met.

conclusionThe HOPES study met all pre-specified progression targets to a progress to a larger trial. High acceptability and positive feasibility outcomes, and provision of exploratory data that showed a preliminary signal of potential benefit all support progression to a larger trial.

trial registrationClinicalTrials.gov Identifier: NCT05636553 Registered 3rd December 2022 and the trial is completed. https://clinicaltrials.gov/study/NCT05636553 .