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Behavioral Intervention
Mindfulness Practices 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from before the patient's intervention visit to their subsequent re-evaluation. this time span is typically around 6 weeks.
Awards & highlights
Study Summary
This trial investigates the effects of 3 audio-recorded mindfulness interventions on foot and ankle pain relative to a control.
Who is the study for?
This trial is for adults over 18 seeking treatment for foot and ankle pain at the University Orthopaedic Center. It's not suitable for those with a current cancer diagnosis, unstable illnesses that could affect participation, or cognitive impairments preventing them from following study procedures.Check my eligibility
What is being tested?
The trial is testing three different brief mindfulness practices against basic pain coping information to see which helps more with foot and ankle pain. Participants will be randomly assigned to one of four groups and listen to a short audio recording related to their group.See study design
What are the potential side effects?
Since this trial involves non-invasive mindfulness practices and educational information, there are no significant side effects expected. However, some individuals might experience discomfort or emotional distress when engaging in mindfulness if it brings up difficult thoughts or feelings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from before the patient's intervention visit to their subsequent re-evaluation. this time span is typically around 6 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from before the patient's intervention visit to their subsequent re-evaluation. this time span is typically around 6 weeks.
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 Numeric Rating Scale
Secondary outcome measures
Change in Pain Intensity Numeric Rating Scale
Change in Pain Medication Desire Numeric Rating Scale
Other outcome measures
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Pain Introduction + Mindfulness Introduction + Mindfulness PracticeExperimental Treatment1 Intervention
Group II: Mindfulness Practice (alone)Experimental Treatment1 Intervention
Group III: Mindfulness Introduction + Mindfulness PracticeExperimental Treatment1 Intervention
Group IV: Pain Coping InformationActive Control1 Intervention
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Who is running the clinical trial?
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,701 Total Patients Enrolled
22 Trials studying Pain
176,964 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any cognitive issues that prevent me from following study procedures.I am currently diagnosed with cancer.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Introduction + Mindfulness Practice
- Group 2: Pain Coping Information
- Group 3: Pain Introduction + Mindfulness Introduction + Mindfulness Practice
- Group 4: Mindfulness Practice (alone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there presently any vacancies for this clinical trial?
"Per clinicaltrials.gov, this experiment is not currently accepting participants. Initially posted on July 31st 2023 and last updated in early July of the same year, there are no new patients being recruited for this particular study; however, 378 alternative studies are actively enrolling individuals at present."
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