Acute Pain, Pain
Conditions
Keywords
Mindfulness
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALMindfulness 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.
BEHAVIORALMindfulness 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.
BEHAVIORALMindfulness 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
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Numeric Rating Scale | 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. |
| Change in Anxiety Numeric Rating Scale | 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. |
Countries
United States
Outcome results
None listed