A Combination Mindfulness and Music Intervention for Acute Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Florida State University
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- Change in Pain Unpleasantness Numeric Rating Scale
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Adam Hanley
Principal Investigator
Florida State University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- 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)