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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Information | Active Comparator |
| |
| Mindfulness Practice (alone) | Experimental |
| |
| Mindfulness Introduction + Mindfulness Practice | Experimental |
| |
| Pain Introduction + Mindfulness Introduction + Mindfulness Practice | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Information | Behavioral | A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | Immediately before to after 3-minute audio recording |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. | Immediately before to after 3-minute audio recording |
| Change in Pain Medication Desire Numeric Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Mindfulness Practice (alone) | Behavioral | A 3-minute audio-guided mindfulness practice. |
|
| Mindfulness Introduction + Mindfulness Practice | Behavioral | A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice |
|
| Pain Introduction + Mindfulness Introduction + Mindfulness Practice | Behavioral | 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 |
|
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. |
| Immediately before to after 3-minute audio recording |
| From before the patient's intervention visit to their subsequent re-evaluation. This time span is typically around 6 weeks. |
| D012959 |
| Socioeconomic Factors |