Brief Behavioral Intervention for Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Acute Pain; Pain
• Interventions: Behavioral: Mindful Pain Management; Behavioral: Pain Psychoeducation

• Registration Number: NCT06471075
• Lead Sponsor: Florida State University

Brief Summary

This project is a single-site, two-arm, randomized controlled trial designed to investigate the impact of a brief (i.e., \<10 minute) behavioral intervention on pain among patients seeking treatment at the Tallahassee Orthopedic Clinic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Start: 2024-08-01
• Primary Completion: 2026-09-11
• Study Completion: 2026-09-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

• Recieving pain treatment at Tallahassee Orthopedic Center
• being able not to commit to another (new) treatment during the course of the study
• understanding English instructions fluently
• Being 18 and above

Exclusion Criteria

• Unable to consent because of physical or mental incapacity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Pain Management	Mindful Pain Management	-
Pain Psychoeducation	Pain Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	Immediately before to after 7-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
Acute Pain	Immediately before to after 7-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.
Anxiety	Immediately before to after 7-minute audio recording	Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.
Treatment Satisfaction	At the end of the medical provider visit - approximately 1 hour.	Treatment satisfaction at the visit's end will be measured with three, validated items (1. How satisfied are you with your medical care today?, 2. Was the visit/procedure tolerable?, 3. Would you have the same procedure again?), each scored on an 11-point, Likert-type scale ranging from 0 to 10. Higher scores represent greater treatment satisfaction

Trial Locations

Locations (1)

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