Pain
Conditions
Brief summary
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention 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).
BEHAVIORALMindful Pain Management
A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 * Seeking foot or ankle treatment at the Tallahassee Orthopedic Center
Exclusion criteria
* • Cognitive impairment preventing completion of study procedures. * Current cancer diagnosis, * Other unstable illness judged by medical 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. |
| Change in Depression Numeric Rating Scale | Immediately before to after 4-minute audio recording] | Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression. |
Countries
United States
Outcome results
None listed