One in ten to nearly half of people who have orthopaedic surgery for osteoarthritis still suffer persistent pain and reduced function afterwards. Existing pre-surgery interventions like education, exercise, and cognitive behavioural therapy do not reliably fix this. This feasibility study tests whether an eight-week mindfulness course, delivered before surgery, could improve outcomes for these patients. The researchers will survey healthcare staff to identify what helps or hinders introducing mindfulness into orthopaedic care. They will then run a small trial with 100 patients on a surgical waitlist, randomly assigning them to one of three mindfulness programmes of different lengths. Interviews with 20 participants will explore their experiences. The goal is to decide whether a full-scale randomised controlled trial is warranted. If the approach proves feasible and acceptable, a future definitive trial could show that pre-operative mindfulness reduces chronic pain and improves mobility after joint surgery. That would give surgeons and patients a low-cost, drug-free option to add to standard care—potentially changing how thousands of people prepare for and recover from hip or knee replacements each year.
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Title: Pre-operative mindfulness to improve outcomes following orthopaedic surgery Background: Interventions such as education, exercise and cognitive behavioural therapy are not consistently effective in improving outcomes for the 10-47% of people who report persistent pain and reduced function after orthopaedic surgery for osteoarthritis. This is a feasibility study to determine if a future randomised controlled trial (RCT) is warranted to assess the effectiveness of an eight-week mindfulness course in improving patient outcomes. Aims: To survey healthcare staff to identify barriers and facilitators for implementing mindfulness in orthopaedics To test the acceptability and feasibility of a proposed RCT To explore participants' experience of mindfulness and taking part in the feasibility study through qualitative interviewing Methods: The study will consist of three work packages: Work Package 1: A survey and subsequent focus groups with healthcare staff to identify barriers and facilitators for implementing mindfulness in orthopaedics. A digital survey will be disseminated through national professional bodies and social media. It will include a question asking for consent to be contacted about participating in a focus group Four, 60-minute online focus groups with four to six participants in each will be conducted Work Package 2: A parallel multi-centre, multi-arm randomised feasibility study will be conducted to test the acceptability and feasibility of a proposed RCT to investigate the effectiveness of mindfulness before orthopaedic surgery for osteoarthritis in improving pain and function after surgery. 100 patients on a waitlist for an orthopaedic operation for osteoarthritis will be recruited Participants will be randomised to one of three arms: Eight-week mindfulness course Brief mindfulness Ultra-brief mindfulness Outcome measurement will occur at: four to six months before surgery (before mindfulness training); Two weeks before surgery (after mindfulness training); three months after surgery Clinical patient-reported outcome measures, health utilisation, adverse events and adherence data will be collected Analysis will interpret findings in accordance with pre-determined progression criteria to decide if a definitive trial should be conducted Work Package 3: Semi-structured interviews to explore the participants' experience of mindfulness in orthopaedics and taking part in the feasibility study. 20 participants who agreed to be contacted for interview in the initial consent form will be invited to participate in one-to-one telephone/virtual interviews Interview data will be organised and managed in QSR NVivo to facilitate thematic analysis Timelines for delivery: 0-4 months Work package (WP) 1. Submit for research and ethics approval 4-12 months WP 1. Survey and focus group 6-12 months WP 2. Submit for research and ethics approval 13-16 months WP 2. Study and site set-up 16-23 months WP 2. Recruitment, assessments and randomisation 17-26 months WP 2. Interventions delivered 22-32 months WP 2. Final outcomes collected 33-37 months WP 2. Data cleaning and analysis 23-39 months WP 3. Semi-structured interviews and analysis 39-45 months Findings written up and disseminated Anticipated impact and dissemination plan This study will assess if it is feasible to proceed to a definitive trial. Findings will be disseminated through charities, peer-reviewed journals and conferences.
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