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This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic 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. Analgesic mechanisms of mindfulness will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Information | Active Comparator |
| |
| Mindful Pain Management | Experimental |
|
| 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 Decentering |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 41214294 | Derived | Hanley AW, Gibson R, Davis A, Stecher C, Childs K, Worts P. Mindfulness in the Orthopedic Clinic Waiting Room Decreases Pain: Results From A Randomized Controlled Trial. Int J Behav Med. 2025 Nov 10. doi: 10.1007/s12529-025-10398-3. Online ahead of print. |
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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. |
|
Decentering will be measured by the single, decentering item from the state version of the validated Metacognitive Processes of Decentering Scale. This item will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater decentering.
| Immediately before to after 4-minute audio recording |
| Change in Self-Transcendent State | Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater self-transcendence. | Immediately before to after 4-minute audio recording |