Brief Mindfulness for Foot and Ankle Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pain Coping Information
|
Behavioral: Pain Coping Information
A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)
|
| Experimental: Mindfulness Practice (alone)
|
Behavioral: Mindfulness Practice (alone)
A 3-minute audio-guided mindfulness practice.
|
| Experimental: Mindfulness Introduction + Mindfulness Practice
|
Behavioral: Mindfulness Introduction + Mindfulness Practice
A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice
|
| Experimental: Pain Introduction + Mindfulness Introduction + Mindfulness Practice
|
Behavioral: Pain 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB_00085446 2