Mindfulness Intervention in Orthopedic Trauma Patients

Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety
• Intervention / Treatment: Behavioral: Mind wandering; Behavioral: Preoperative mindfulness; Behavioral: Postoperative mindfulness

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam W Hanley; Phone Number: 8012134191; Email: adam.hanley@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Adam W Hanley; Phone Number: 801-213-4191

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Mind wandering	Behavioral: Mind wandering; A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."
Active Comparator: Preoperative Mindfulness; Participants will only listen to the guided meditation practice before surgery.	Behavioral: Mind wandering; A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."; Behavioral: Preoperative mindfulness; A seven-minute, audio-guided, mindfulness meditation practice.
Active Comparator: Preoperative and Postoperative Mindfulness; Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.	Behavioral: Preoperative mindfulness; A seven-minute, audio-guided, mindfulness meditation practice.; Behavioral: Postoperative mindfulness; A seven-minute, audio-guided, mindfulness meditation practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preoperative Anxiety	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.	Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Pain Unpleasantness	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.	Immediately before to after the 7-minute postoperative intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preoperative Pain Intensity	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.	Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Pain Intensity	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.	Immediately before to after the 7-minute postoperative intervention
Change in Preoperative Pain Unpleasantness	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.	Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Anxiety	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.	Immediately before to after the 7-minute postoperative intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect better physical functioning.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1	The PROMIS pain interference computer assisted test draws from a bank of 40 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater pain interference.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0	The PROMIS anxiety computer assisted test draws from a bank of 29 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater anxiety.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0	The PROMIS depression computer assisted test draws from a bank of 28 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores reflect greater depression.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00085446 AM_00046459

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No