Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- University of Utah
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Change in Preoperative Anxiety
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.
Investigators
Adam Hanley
Assistant Professor
University of Utah
Eligibility 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
Outcomes
Primary Outcomes
Change in Preoperative Anxiety
Time Frame: Immediately before to after the 7-minute preoperative intervention
Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater anxiety.
Change in Postoperative, In-patient Pain Unpleasantness
Time Frame: Immediately before to after the 7-minute postoperative intervention
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Secondary Outcomes
- Change in Postoperative, In-patient Anxiety(Immediately before to after the 7-minute postoperative intervention)
- Change in Preoperative Pain Intensity(Immediately before to after the 7-minute preoperative intervention)
- Change in Postoperative, In-patient Pain Intensity(Immediately before to after the 7-minute postoperative intervention)
- Change in Preoperative Pain Unpleasantness(Immediately before to after the 7-minute preoperative intervention)