A Combination Mindfulness and Music Intervention for Acute Pain

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

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Florida State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-02

Primary Completion

2025-04-09

Completion

2025-04-09

Countries

• United States

Study Locations