A Combination Mindfulness and Music Intervention for Acute Pain

Florida State University

Status: Completed

Conditions: Acute Pain; Pain

Treatments: Behavioral: Mindfulness Recording with Binaural Beats; Behavioral: Mindfulness Pain Management; Behavioral: Mindfulness Recording With Sustained Tone; Behavioral: Mindfulness Recording with Binaural Beats and Theta Music

Study type: Interventional

Funder types: Other

Identifiers

NCT06718218

STUDY00004916_BB

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 4 patient groups

Mindfulness Pain Management

Active Comparator group

Treatment:

Behavioral: Mindfulness Pain Management

Mindfulness Recording With Sustained Tone

Experimental group

Treatment:

Behavioral: Mindfulness Recording With Sustained Tone

Mindfulness Recording with Binaural Beats

Experimental group

Treatment:

Behavioral: Mindfulness Recording with Binaural Beats

Mindfulness Recording with Binaural Beats and Theta Music

Experimental group

Treatment:

Behavioral: Mindfulness Recording with Binaural Beats and Theta Music