Mindfulness Intervention in Orthopedic Trauma Patients

Not Applicable

Completed

• Conditions: Pain; Anxiety

• Registration Number: NCT05634278
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-02
• Primary Completion: 2023-09-21
• Study Completion: 2023-11-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Preoperative Anxiety	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	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 Outcome Measures

Name	Time	Method
Change in Postoperative, In-patient Anxiety	Immediately before to after the 7-minute postoperative 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 Preoperative Pain Intensity	Immediately before to after the 7-minute preoperative intervention	Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Change in Postoperative, In-patient Pain Intensity	Immediately before to after the 7-minute postoperative intervention	Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Change in Preoperative Pain Unpleasantness	Immediately before to after the 7-minute preoperative 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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States