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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Information | Active Comparator | Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery). |
|
| Mindful Pain Management | Experimental | Participants will be randomized to listen to 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Information | Behavioral | A 4-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 4-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 4-minute audio recording |
| Change in Anxiety Numeric Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
• Cognitive impairment preventing completion of study procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Orthopedic Clinic (TOC) | Tallahassee | Florida | 32308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38757714 | Derived | Hanley AW, Wilson Zingg R, Smith B, Zappa M, White S, Davis A, Worts PR, Culjat C, Martorella G. Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials. J Integr Complement Med. 2024 Nov;30(11):1082-1091. doi: 10.1089/jicm.2024.0020. Epub 2024 May 17. |
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All data is aggregated and anonymous.
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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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| Mindful Pain Management | Behavioral | 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. |
|
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety. |
| Immediately before to after 4-minute audio recording |
| Change in Depression Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression. | Immediately before to after 4-minute audio recording] |