Mindfulness Intervention in Orthopedic Trauma Patients

June 16, 2025 updated by: Adam Hanley, University of Utah

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
Immediately before to after the 7-minute preoperative intervention
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.
Immediately before to after the 7-minute postoperative intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Preoperative Pain Intensity
Time Frame: 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.
Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Pain Intensity
Time Frame: 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.
Immediately before to after the 7-minute postoperative intervention
Change in Preoperative Pain Unpleasantness
Time Frame: 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.
Immediately before to after the 7-minute preoperative intervention
Change in Postoperative, In-patient Anxiety
Time Frame: 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.
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
Time Frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
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
Time Frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
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
Time Frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
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
Time Frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Actual)

September 21, 2023

Study Completion (Actual)

November 27, 2023

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)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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