Mindfulness Intervention in Orthopedic Trauma Patients

Not Applicable

Recruiting

• Conditions: Pain; Anxiety
• Interventions: Behavioral: Preoperative mindfulness; Behavioral: Mind wandering; Behavioral: Postoperative mindfulness

• 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
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Arm && Interventions

Group	Intervention	Description
Preoperative Mindfulness	Preoperative mindfulness	Participants will only listen to the guided meditation practice before surgery.
Mind wandering	Mind wandering	-
Preoperative Mindfulness	Mind wandering	Participants will only listen to the guided meditation practice before surgery.
Preoperative and Postoperative Mindfulness	Preoperative mindfulness	Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.
Preoperative and Postoperative Mindfulness	Postoperative mindfulness	Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.

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