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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Postoperative, In-patient Pain Unpleasantness

Change in Preoperative Anxiety

Secondary outcome measures

Change in Postoperative, In-patient Anxiety

Change in Postoperative, In-patient Pain Intensity

Change in Preoperative Pain Intensity

+1 more

Other outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,599 Total Patients Enrolled

22 Trials studying Pain

177,074 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity of this medical experiment?

"Indeed, it is. As per the current available information on clinicaltrials.gov, this medical research was initially launched in November 14th 2022 and has seen its last update recently on November 21st 2022. The trial seeks to secure 90 participants across a solitary site."

Answered by AI

Is my participation in this trial possible?

"To qualify for this trial, prospective patients should have a diagnosis of anxiety and be within the 18-65 age range. This research initiative is currently looking to recruit up to 90 individuals."

Answered by AI

Are there any vacant slots for participants in this experiment?

"Correct. Data available on clinicaltrials.gov confirms that this medical research, which was first posted in November 14th 2022, is actively searching for participants. Approximately 90 patients must be enrolled from 1 different healthcare centres."

Answered by AI