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

NCT07486505 | Not Yet Recruiting

• 1 other identifier: MIRROR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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; Opioid Use After Surgery

Keywords

fractures; mindfulness; pain management; fracture surgery; opioid use; anxiety

Outcome Measures

Primary Outcomes (6)

• Proportion of eligible patients who provide informed consent

  To determine the feasibility of participant enrollment, the number of eligible patients who consent to the study will be counted and a percentage generated. This percentage should be over 40% but no fewer than 30%.

  Through study completion, an average of 6 months

• Length of time it takes to enroll 50 participants

  To determine the feasibility of participant enrollment, the length of time it takes to enroll 50 participants will be counted. This should take less than 8 weeks and no more than 12 weeks.

  Through study completion, an average of 6 months

• Review of reasons for exclusions

  To determine the feasibility of participant enrollment, the reasons for exclusion from the study will be reviewed. This will be a qualitative analysis of the screening data.

  Through study completion, an average of 6 months

• Proportion of participants assigned to the treatment arm who complete both phases of the MBI

  To determine the feasibility of the intervention and data collection, the number of participants in the treatment arm who complete both phases of the MBI will be calculated. This should be greater than 90% but no fewer than 70%.

  Through study completion, an average of 6 months

• Proportion of complete data in all case report forms

  To determine the feasibility of the intervention and data collection, the proportion of complete data in all case report forms will be calculated. 5% or less of data can be missing, but no more than 10%.

  Through study completion, an average of 6 months

• Proportion of participants who withdraw consent to participate

  To determine the feasibility of the intervention and data collection, the proportion of participants who withdraw consent to participant will be calculated. This should be fewer than 5%, but no more than 10%.

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• Pain, Enjoyment of Life and General Activity

  For 6 weeks from the date of enrollment

• Numeric Pain Rating Scale

  For 6 weeks from the date of enrollment

• Anxiety Visual Analogue Scale

  For 6 weeks from the date of enrollment

• Pain Catastrophizing Scale

  For 6 weeks from the date of enrollment

• Opioid Use

  For 6 weeks from the date of enrollment

Study Arms (2)

Mindfulness Based Intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Intervention

Educational Recording

SHAM COMPARATOR

Participants will be provided with an iPad and headphones to listen to a time-matched audio recording before surgery, and then again after surgery.

Behavioral: Educational Recording

Interventions

Mindfulness Based Intervention BEHAVIORAL

Two 7-minute audio-guided videos, one on breathing practices, the second on pain management

Mindfulness Based Intervention

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.

Educational Recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older; and
• Presenting to the hospital with an open or closed appendicular fracture requiring internal fixation. Patients with multiple fractures may be included.

You may not qualify if:

• Does not have the English-language skills required to participate in trial interventions (in the judgement of site research personnel);
• Cognitive impairment (including traumatic brain injury);
• Auditory or visual impairment that would inhibit ability to receive intervention;
• Current incarceration;
• Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture;
• Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;
• Active psychosis;
• Active suicidality;
• Stress fracture;
• Fragility fracture;
• Currently enrolled in a study that does not permit co-enrolment in other trials;
• Not willing to participate in the intervention;
• No provision of informed consent; or
• Other reason as approved by the Data Coordinating Centre.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Fractures, Bone; Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jodi Gallant, MSc

CONTACT

289-237-3526; gallaj4@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-01

Locations

CA (1)