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Completed

NCT Number: NCT06718218

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.

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Key information

Conditions

Pain Acute Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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 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.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: 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 outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: 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.

  2. Change in Anxiety Numeric Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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