Pain
Conditions
Brief summary
This is a single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation.
Interventions
BEHAVIORALPain Coping Information
A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)
BEHAVIORALMindfulness Practice (alone)
A 3-minute audio-guided mindfulness practice.
BEHAVIORALMindfulness Introduction + Mindfulness Practice
A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice
BEHAVIORALPain Introduction + Mindfulness Introduction + Mindfulness Practice
A 1-minute audio-recorded introduction to pain, followed by a 1-minute audio-recorded introduction the practice of mindfulness, followed by a 1-minute audio-guided mindfulness practice
Sponsors
University of Utah
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
No
Inclusion criteria
* Age ≥18 * Seeking foot or ankle treatment at the University Orthopaedic 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 3-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 3-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 Pain Medication Desire Numeric Rating Scale | Immediately before to after 3-minute audio recording | Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 | From before the patient's intervention visit to their subsequent re-evaluation. This time span is typically around 6 weeks. | The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning. |
Countries
United States
Outcome results
None listed