Recruiting

Mindfulness Exercises

Sponsor:

McMaster University

Code:

NCT07486505

Conditions

Orthopaedic Fractures

Orthopaedic Trauma Fractures and Non-unions

Orthopaedic Trauma

Orthopaedic Surgery

Orthopaedic Related Pain (Musculoskeletal Pain)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Based Intervention

Educational Recording

Study Details

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)

Study ID

NCT07486505

Start date

Aug 27, 2026

Status verified date

Mar, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

The inclusion criteria are:

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

The exclusion criteria are:

1. Does not have the English-language skills required to participate in trial interventions (in the judgement of site research personnel);
2. Cognitive impairment (including traumatic brain injury);
3. Auditory or visual impairment that would inhibit ability to receive intervention;
4. Current incarceration;
5. 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;
6. Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;
7. Active psychosis;
8. Active suicidality;
9. Stress fracture;
10. Fragility fracture;
11. Currently enrolled in a study that does not permit co-enrolment in other trials;
12. Not willing to participate in the intervention;
13. No provision of informed consent; or
14. Other reason as approved by the Data Coordinating Centre.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Mindfulness Based Intervention

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

Educational Recording

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.

Primary outcome measure

  • Proportion of eligible patients who provide informed consent [ Time Frame: Through study completion, an average of 6 months ]
  • Length of time it takes to enroll 50 participants [ Time Frame: Through study completion, an average of 6 months ]
  • Review of reasons for exclusions [ Time Frame: Through study completion, an average of 6 months ]
  • Proportion of participants assigned to the treatment arm who complete both phases of the MBI [ Time Frame: Through study completion, an average of 6 months ]
  • Proportion of complete data in all case report forms [ Time Frame: Through study completion, an average of 6 months ]
  • Proportion of participants who withdraw consent to participate [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Jodi Gallant, MSc

905-870-0613gallaj4@mcmaster.ca

Locations

Hamilton Health Sciences - Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Kaitlyn Pusztai, HBSc

905-870-0613pusztake@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Oct 7, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.