A Combination Mindfulness and Music Intervention for Acute Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain; Acute Pain
• Intervention / Treatment: Behavioral: Mindfulness Pain Management; Behavioral: Mindfulness Recording With Sustained Tone; Behavioral: Mindfulness Recording with Binaural Beats; Behavioral: Mindfulness Recording with Binaural Beats and Theta Music

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Orthopedic Clinic (TOC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness Pain Management	Behavioral: Mindfulness Pain Management; Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice.
Experimental: Mindfulness Recording With Sustained Tone	Behavioral: Mindfulness Recording With Sustained Tone; Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice, that is accompanied by a sustained low C tone at 65.41 Hertz.
Experimental: Mindfulness Recording with Binaural Beats	Behavioral: Mindfulness Recording with Binaural Beats; Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear.
Experimental: Mindfulness Recording with Binaural Beats and Theta Music	Behavioral: Mindfulness Recording with Binaural Beats and Theta Music; Participants will listen to a 5-minute audio recording of a mindfulness exercise consisting of a 1-minute introduction to mindful pain management and a 4-minute mindfulness practice that is accompanied by binaural beats resulting from the delivery of a sustained 65.41 Hertz tone in the left ear and a sustained 69.41 Hertz tone in the right ear as well as instrumental theta wave music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Unpleasantness Numeric Rating Scale	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.	Immediately before and after 5-minute audio recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Numeric Rating Scale	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.	Immediately before and after 5-minute audio recording
Change in Anxiety Numeric Rating Scale	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.	Immediately before and after 5-minute audio recording

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: STUDY00004916_BB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No