Orthopaedic Fractures study: Educational Recording
Official title 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
ClinicalTrials.gov ID: NCT07486505
What this study is testing
- What it's testing
- The study wants to see if a brief mindfulness program is practical and if it might lower pain, anxiety, and opioid use six weeks after fracture surgery.
- Who it's for
- Adults who have broken arms or legs and need surgery at Hamilton General Hospital.
- What's involved
- Participants will listen to a 7‑minute audio recording either a mindfulness exercise or an educational talk before and after surgery, and will report pain, anxiety, and medication use.
- Time commitment
- The study lasts about six weeks after surgery, with two audio sessions and follow‑up assessments during that time.
- Time commitment: about 6 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults 18 years of age or older; and
- Presenting to the hospital with an open or closed appendicular fracture requiring internal fixation.
You likely can't join 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...
- Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;
See the full eligibility criteria
- 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. The
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.