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Mindfulness Intervention for Pain Management in Orthopedic Trauma

N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

Summary

This trial studies how well 3 treatments work for people with broken legs needing surgery.

Who is the study for?
This trial is for English-speaking adults aged 18-65 with a clear mind (Glasgow Coma Scale of 15) who have an acute lower extremity fracture that requires surgery. They must be willing to participate in the study. It's not for those planning more surgeries, currently incarcerated, pregnant or breastfeeding women, or those with cognitive impairments.
What is being tested?
The study tests mindfulness techniques before and after surgery against mind wandering control in managing anxiety and pain post-surgery. Participants are randomly placed into one of three groups at a level 1 trauma center.
What are the potential side effects?
Mindfulness practices are generally safe but may include temporary increases in distress, emotional discomfort when confronting difficult thoughts or feelings, and potential frustration if expectations are not met.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Postoperative, In-patient Pain Unpleasantness
Change in Preoperative Anxiety
Secondary study objectives
Change in Postoperative, In-patient Anxiety
Change in Postoperative, In-patient Pain Intensity
Change in Preoperative Pain Intensity
+1 more
Other study objectives
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Preoperative MindfulnessActive Control2 Interventions
Participants will only listen to the guided meditation practice before surgery.
Group II: Preoperative and Postoperative MindfulnessActive Control2 Interventions
Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.
Group III: Mind wanderingPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,140 Previous Clinical Trials
1,697,640 Total Patients Enrolled
24 Trials studying Pain
177,464 Patients Enrolled for Pain

Media Library

Preoperative Mindfulness Clinical Trial Eligibility Overview. Trial Name: NCT05634278 — N/A
Pain Research Study Groups: Mind wandering, Preoperative Mindfulness, Preoperative and Postoperative Mindfulness
Pain Clinical Trial 2023: Preoperative Mindfulness Highlights & Side Effects. Trial Name: NCT05634278 — N/A
Preoperative Mindfulness 2023 Treatment Timeline for Medical Study. Trial Name: NCT05634278 — N/A
~30 spots leftby Nov 2025
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