Pain, Acute
Conditions
Brief summary
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of two, 4-minute, audio-recorded, music interventions (one with lyrics and the other without) for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.
Interventions
BEHAVIORALPain Coping Information
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
BEHAVIORALLyrical Music
A 4-minute audio recording of Leonard Cohen's song Hallelujah sung by Rufus Wainwright with choral accompaniment.
BEHAVIORALInstrumental Music
A 4-minute audio recording of instrumental, theta wave music.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Seeking treatment at the Tallahassee Orthopedic Center
Exclusion criteria
* Cognitive impairment preventing completion of study procedures. * Other unstable illness judged by research staff to interfere with study involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | Immediately before to after 4-minute audio recording | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Numeric Rating Scale | Immediately before to after 4-minute audio recording | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. |
| Change in Anxiety Numeric Rating Scale | Immediately before to after 4-minute audio recording | Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety, |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Transcendent State | Immediately before to after 4-minute audio recording | Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored on a Likert scale ranging from 0-10, with higher scores representing greater self-transcendence. |
| Experience of Emotional Chills | Immediately after 4-minute audio recording | Emotional chills and goosebumps will be measured with two items, each scored on a 0 to 10 Likert type scale. Higher score represent more chills/goosebumps. |
Countries
United States
Outcome results
None listed