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Mindfulness of Pain for Pain

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
Scheduled to undergo total joint arthroplasty of the knee or hip
Age ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Awards & highlights

Study Summary

This trial will compare five different audio-recorded mindfulness practices delivered via app to patients undergoing knee or hip replacement surgery, delivered 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.

Who is the study for?
This trial is for adults over 18 who are scheduled for knee or hip replacement surgery. Participants must be able to read English and not have cognitive impairments that would prevent them from completing study activities.Check my eligibility
What is being tested?
The trial is testing five different types of short mindfulness exercises delivered through an app. These include Breath Counting, Body Scan, Mindful Breathing, Mindfulness of Pain, and Mindful Savoring. They're given at specific times before and after the surgery to see which helps most with depression, pain, and anxiety.See study design
What are the potential side effects?
Mindfulness practices typically do not cause physical side effects but may bring up emotional discomfort or distress as individuals become more aware of their thoughts and feelings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a total knee or hip joint replacement.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment 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 Pain Unpleasantness
Secondary outcome measures
Change in Pain Intensity
Change in Pain Medication Desire
Other outcome measures
Change in Anxiety
Change in Depression
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness of PainExperimental Treatment1 Intervention
Group II: Mindful SavoringExperimental Treatment1 Intervention
Group III: Mindful BreathingExperimental Treatment1 Intervention
Group IV: Body ScanExperimental Treatment1 Intervention
Group V: Breath CountingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Breathing
2019
N/A
~160
Mindfulness of Pain
2019
N/A
~120

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,417 Total Patients Enrolled
22 Trials studying Pain
176,859 Patients Enrolled for Pain

Frequently Asked Questions

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

How many people have registered to participate in this experiment?

"Affirmative, clinicaltrials.gov indicates that this trial began recruitment on June 22nd 2022 and is still active today. 305 participants are required for the research taking place at 1 location."

Answered by AI

Are there any vacancies remaining for participants in this experiment?

"As per the information listed on clinicaltrials.gov, this particular trial is still open for patient enrollment. It was originally posted on June 22nd 2022 and its latest update was registered five days later."

Answered by AI
~47 spots leftby Aug 2024