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This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Psychoeducation | Active Comparator | In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being. |
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| Mindfulness without Psychoeducation | Experimental | In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning. |
|
| 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus) | Experimental | In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping. |
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| 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus) | Experimental | In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Psychoeducation | Behavioral | In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness. | Immediately before to after 3-minute audio recording |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Numeric Rating Scale | Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity. | Immediately before to after 3-minute audio recording |
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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 |
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| 2 Minutes of Psychoeducation with 1 Minute of Mindfulness | Experimental | In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing. |
|
| Mindfulness without Psychoeducation | Behavioral | In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning. |
|
| 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus) | Behavioral | In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping. |
|
| 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus) | Behavioral | In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning. |
|
| 2 Minutes of Psychoeducation with 1 Minute of Mindfulness | Behavioral | In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing. |
|
| Change in Anxiety Numeric Rating Scale |
Change in anxiety from baseline will be assessed a single item adapted from the Generalized Anxiety Disorder-2. Scores range from 0 to 10, with higher scores reflecting greater anxiety. |
| Immediately before to after 3-minute audio recording |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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