Does Choice Improve the Pain Relief Derived From a Brief Intervention

Not Applicable

Completed

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

• Registration Number: NCT06582758
• Lead Sponsor: Florida State University

Brief Summary

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

Detailed Description

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-03
• Study Start: 2024-09-04
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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
Mindful Pain Management (randomized)	Mindful Pain Management	-
Pain Psychoeducation (randomized)	Pain Psychoeducation	-
Choice: Mindful Pain Management	Mindful Pain Management	-
Choice: Pain Psychoeducation	Pain Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	Immediately before to after 7 to 10-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 7 to 10-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 7 to 10-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.

Trial Locations

Locations (1)

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