A Combination Mindfulness and Music Intervention for Acute Pain

NCT06718218 | Completed

• 1 other identifier: STUDY00004916_BB
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Acute Pain

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before and after 5-minute audio recording

• Change in Anxiety Numeric Rating Scale

  Immediately before and after 5-minute audio recording

Study Arms (4)

Mindfulness Pain Management

ACTIVE COMPARATOR

Behavioral: Mindfulness Pain Management

Mindfulness Recording With Sustained Tone

EXPERIMENTAL

Behavioral: Mindfulness Recording With Sustained Tone

Mindfulness Recording with Binaural Beats

EXPERIMENTAL

Behavioral: Mindfulness Recording with Binaural Beats

Mindfulness Recording with Binaural Beats and Theta Music

EXPERIMENTAL

Behavioral: Mindfulness Recording with Binaural Beats and Theta Music

Interventions

Mindfulness Pain Management BEHAVIORAL

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.

Mindfulness Pain Management

Mindfulness Recording With Sustained Tone BEHAVIORAL

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.

Mindfulness Recording With Sustained Tone

Mindfulness Recording with Binaural Beats BEHAVIORAL

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.

Mindfulness Recording with Binaural Beats

Mindfulness Recording with Binaural Beats and Theta Music BEHAVIORAL

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.

Mindfulness Recording with Binaural Beats and Theta Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to consent because of physical or mental incapacity.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 2, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)