A Combination Mindfulness and Music Intervention for Acute Pain

Not Applicable

Recruiting

• Conditions: Pain; Acute Pain

• Registration Number: NCT06718218
• Lead Sponsor: Florida State University

Brief Summary

This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-05-02
• Study Completion: 2025-05-02

Recruitment & Eligibility

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

Inclusion Criteria

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

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 and after 5-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 and after 5-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 and after 5-minute audio recording	Change in anxiety from baseline will be assessed with an item adapted from the Generalized Anxiety Disorder 2-item. Scores range from 0 to 10, with higher scores reflecting greater anxiety.

Trial Locations

Locations (1)

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