Brief Mindfulness for Foot and Ankle Pain

Study Overview
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Brief Summary
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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.

Official Title
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Brief Mindfulness for Foot and Ankle Pain

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Pain Coping Information
* Behavioral: Mindfulness Practice (alone)
* Behavioral: Mindfulness Introduction + Mindfulness Practice
* Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain Coping Information<br> | Behavioral: Pain Coping Information<br>* A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)<br>|
| Experimental: Mindfulness Practice (alone)<br> | Behavioral: Mindfulness Practice (alone)<br>* A 3-minute audio-guided mindfulness practice.<br>|
| Experimental: Mindfulness Introduction + Mindfulness Practice<br> | Behavioral: Mindfulness Introduction + Mindfulness Practice<br>* A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice<br>|
| Experimental: Pain Introduction + Mindfulness Introduction + Mindfulness Practice<br> | Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |