Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention

Not Applicable

Recruiting

• Conditions: Pain; Acute Pain

• Registration Number: NCT06952049
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-10
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	Immediately before to after 3-minute audio recording	Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity Numeric Rating Scale	Immediately before to after 3-minute audio recording	Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.
Change in Anxiety Numeric Rating Scale	Immediately before to after 3-minute audio recording	Change in anxiety from baseline will be assessed a single item adapted from the Generalized Anxiety Disorder-2. Scores range from 0 to 10, with higher scores reflecting greater anxiety.

Trial Locations

Locations (1)

Tallahassee Orthopedic Clinic (TOC); 🇺🇸 Tallahassee, Florida, United States