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Purpose

This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Receiving pain treatment at Tallahassee Orthopedic Center - Understanding English instructions fluently - Being 18 years of age or older

Exclusion Criteria

  • Unable to consent because of physical or mental incapacity.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Pain Psychoeducation 		In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
  • Behavioral: Pain Psychoeducation
    In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
Experimental
Mindfulness without Psychoeducation 		In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.
  • Behavioral: Mindfulness without Psychoeducation
    In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.
Experimental
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus) 		In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.
  • Behavioral: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)
    In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.
Experimental
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus) 		In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.
  • Behavioral: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)
    In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.
Experimental
2 Minutes of Psychoeducation with 1 Minute of Mindfulness 		In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.
  • Behavioral: 2 Minutes of Psychoeducation with 1 Minute of Mindfulness
    In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Recruiting Locations

Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida 32308
Contact:
Emilie Miley
emilie.miley@teamtoc.com

More Details

NCT ID
NCT06952049
Status
Recruiting
Sponsor
Florida State University

Study Contact

Adam Hanley
850-645-9557
adam.hanley@fsu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center