The feasibility and acceptability of an online mindfulness-based stress reduction program for chronic musculoskeletal pain: protocol for a pilot randomised controlled trial.
Anita B Amorim, Trudy Rebbeck, Nicholas T Van Dam, Charlotte Johnstone, Claire Ashton-James, Nathalia Costa, Talia Barnet-Hepples, Matthew Jennings, Kathryn Refshauge, Evangelos Pappas
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引用次数: 0
Abstract
Background: Chronic musculoskeletal pain conditions affect millions of people worldwide and place a significant burden on individuals and the healthcare systems. Managing chronic musculoskeletal pain requires a multidisciplinary approach that considers biological, psychological, and social factors. However, access to multidisciplinary pain care is challenging, and long wait times can lead to increased stress and health deterioration. Mindfulness-based stress reduction (MBSR) is a mind-body approach developed specifically to reduce the distress of living with chronic conditions, such as chronic musculoskeletal pain. This study proposed a novel approach by offering an online MBSR program to patients on waitlists to attend a multidisciplinary pain clinic in Australia's public healthcare system that could improve health outcomes. The study aims to assess the feasibility, acceptability, and potential efficacy of this approach using a pilot study design with a mixed-methods approach.
Methods: This is a mixed-methods pilot randomised controlled trial with an embedded qualitative study. Participants will be recruited from waitlists at two multidisciplinary pain management centres within the Sydney Local Health District in New South Wales, Australia. This pilot trial will randomly assign 32 individuals with chronic musculoskeletal pain to either an online MBSR group or a usual care control group. Feasibility outcomes, patient-reported outcomes, adherence to mindfulness practice, and adverse events will be assessed using validated questionnaires. Semi-structured interviews will be conducted with participants in the MBSR group to explore their experiences and evaluate acceptability, and barriers and facilitators of engagement with the intervention.
Discussion: This pilot study will evaluate a novel approach to integrating MBSR into the Australian public healthcare system as a mechanism for providing support to individuals with chronic musculoskeletal pain who are waitlisted for a multidisciplinary pain management program. Findings from this study will indicate the feasibility, acceptability, safety, and preliminary efficacy of this approach in terms of patient-reported outcomes to guide the design of future large-scale clinical trials.
Trial registration: This trial was prospectively registered in the Australian New Zealand Clinical Trials Registry (ACTRN12622000822785).
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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