Mindfulness techniques for patients with lower limb fractures
Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
This study is testing if mindfulness techniques can help reduce pain and anxiety for patients having surgery for lower limb fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05634278 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of mindfulness interventions on pain and anxiety in patients undergoing surgery for lower extremity fractures. It is a randomized, three-arm trial conducted at a tertiary level 1 trauma center, comparing preoperative mindfulness, postoperative mindfulness, and a control group focused on mind wandering. The goal is to assess how these interventions can improve patient outcomes during the surgical process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with acute lower extremity fractures requiring surgical intervention.
Not a fit: Patients with cognitive impairments, those who are pregnant or lactating, currently incarcerated individuals, or those planning a secondary procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety in orthopedic trauma patients, leading to improved recovery experiences.
How similar studies have performed: While mindfulness interventions have shown promise in various medical settings, this specific application in orthopedic trauma patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at presentation between 18 and 65 years * Acute lower extremity fracture to be operatively managed * Glasgow Coma Scale of 15 * English speaking * Willingness to participate in study Exclusion Criteria: * Cognitive impairment * Pregnant or lactating woman * Current incarceration * Planned secondary procedure
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Adam W Hanley
- Email: adam.hanley@utah.edu
- Phone: 8012134191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.