Mindfulness for fracture recovery and reduced opioid use before and after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with open or closed appendicular fractures requiring internal fixation at Hamilton General Hospital are randomly assigned to receive a two-part, audio-guided mindfulness program before and after surgery. The intervention consists of two 7-minute mindfulness audio recordings intended to lessen preoperative anxiety and postoperative pain and opioid needs. The study aims to determine feasibility and potential effect on pain, anxiety, and opioid use within current orthopedic care pathways. Recruitment is led by McMaster University with Hamilton Health Sciences as a collaborator, at a single Ontario site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hamilton Health Sciences - Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Jodi Gallant, MSc
• Email: gallaj4@mcmaster.ca
• Phone: 905-870-0613

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.