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

Sponsor
McMaster University
Study ID
NCT07486505
Status
Not Yet Recruiting

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Conditions

  • Anxiety Acute
  • Anxiety After Surgery
  • Opioid Use
  • Opioid Use After Surgery
  • Orthopaedic Fractures
  • Orthopaedic Related Pain (Musculoskeletal Pain)
  • Orthopaedic Surgery
  • Orthopaedic Trauma
  • Orthopaedic Trauma Fractures and Non-unions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness Based Intervention — BEHAVIORAL
    Two 7-minute audio-guided videos, one on breathing practices, the second on pain management
  • Educational Recording — BEHAVIORAL
    7-minute audio educational recording that describes different strategies to cope with pain and anxiety before fracture surgery. A similar recording will also be given after surgery.

Study Details

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.

Key Dates

First listed
Mar 20, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Mindfulness Based Intervention
    Participants will be provided with an iPad and headphones to listen to a 7-minute, audio-guided mindful breathing exercise while waiting for surgery. During their post-operative hospital stay, participants will once again be provided with an iPad and headphones to listen to another 7-minute, audio-guided mindfulness practice focused on pain management.
  • Sham Comparator: Educational Recording
    Participants will be provided with an iPad and headphones to listen to a time-matched audio recording before surgery, and then again after surgery.

Primary Outcome Measure

Proportion of eligible patients who provide informed consent [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

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