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Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery

Study acronym: MIRROR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 30, 2026 → Nov 30, 2026
See other at-risk trials from McMaster University

Record History

  1. Notable Recruitment opened Start date changed from estimate of May 1, 2026 to Aug 27, 2026 · Primary completion pushed from Oct 30, 2026 to Nov 30, 2026 · Completion pushed from Oct 30, 2026 to Jan 30, 2027 · 4 more Show 7 more changesShow less
    • Start date changed from estimate of May 1, 2026 to Aug 27, 2026
    • Primary completion pushed from Oct 30, 2026 to Nov 30, 2026
    • Completion pushed from Oct 30, 2026 to Jan 30, 2027
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description expanded, about 24 words
    • Site details revised
  2. Notable Start date: Mar 1, 2026 to May 1, 2026 Primary and study completion pushed from Jun 30, 2026 to Oct 30, 2026v2 Show 1 more changeShow less
    • Primary and study completion pushed from Jun 30, 2026 to Oct 30, 2026
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2,264 trials monitored
See 97 trials at risk
Breaking a bone is not only physically painful but also emotionally overwhelming. Patients often experience intense pain, anxiety, and uncertainty as they are rushed to hospital, undergo emergency treatment, and prepare for surgery. After surgery, many continue to struggle with pain and rely on opioid medications, which carry serious risks including addiction. In the context of our current opioid epidemic, it's critical that alternative treatment strategies are urgently evaluated. Mindfulness is a practice that helps people focus on the present and has been shown to reduce stress and pain in other settings. In this trial, patients with broken arms or legs who need surgery at Hamilton General Hospital will be randomly assigned to one of two groups who will listen to a two-part, audio recording before and after surgery. Those in the interventional group will engage in a 7-minute audio-guided mindfulness exercise before surgery to help reduce anxiety, and another 7-minute audio-guided mindfulness exercise after surgery to help manage pain. Those in the control group will listen to a 7-minute educational audio recording before surgery and again after surgery. The main goal is to see if this approach is practical-can enough patients be recruited, and will they complete the audio recordings? The study will also look at early signs of whether the intervention helps reduce pain, anxiety, and opioid use six weeks after surgery. If feasible, a larger study can be conducted to determine if these exercises can help patients manage pain and reduce their need for opioids after surgery. If successful, this simple, low-cost approach could be widely used in hospitals to support recovery and reduce reliance on pain medications.
Trial Details
NCT Number NCT07486505
Lead Sponsor McMaster University
Collaborators: Hamilton Health Sciences Corporation
Conditions Orthopaedic Fractures, Orthopaedic Trauma Fractures and Non-unions, Orthopaedic Trauma, Orthopaedic Surgery, Orthopaedic Related Pain (Musculoskeletal Pain), Anxiety Acute, Anxiety After Surgery, Opioid Use +1 more
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov