- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634278
Mindfulness Intervention in Orthopedic Trauma Patients
January 31, 2024 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
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
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 Contact
- Name: Adam W Hanley
- Phone Number: 8012134191
- Email: adam.hanley@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah
-
Contact:
- Adam W Hanley
- Phone Number: 801-213-4191
-
-
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
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
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
|
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.
|
A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."
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.
|
A seven-minute, audio-guided, mindfulness meditation practice.
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
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 (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
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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