Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05634278

Collaborator

(none)

Enrollment

Location

Arms

16.5

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety	Behavioral: Preoperative mindfulness Behavioral: Postoperative mindfulness Behavioral: Mind wandering	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

Actual Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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: Preoperative mindfulness A seven-minute, audio-guided, mindfulness meditation practice. 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 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.

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: Preoperative mindfulness

A seven-minute, audio-guided, mindfulness meditation practice.

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 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.

Outcome Measures

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Change in 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 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.
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 [Assessed at two-week, six-week, and 12-week postoperative follow-up appointments]
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. A high score reflects better physical functioning.

Other Outcome Measures

Healthcare Utilization [From surgical event to the 12-week postoperative follow-up appointment]
Number of participant phone calls to surgical center staff, emergency department visits, hospital readmissions, and medication refills.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Hanley, Assistant Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT05634278

Other Study ID Numbers:

IRB_00085446 AM_00046459

First Posted:

Dec 2, 2022

Last Update Posted:

Dec 2, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 2, 2022