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| Name | Class |
|---|---|
| Vinnitsa National Medical University | OTHER |
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This is a pragmatic randomized controlled trial comparing a single 15-minute mindfulness-based intervention to usual care for patients with chronic pain in Ukraine being seen in a pain clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief mindfulness | Experimental | A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques. |
|
| Usual care | Active Comparator | 15 minutes of usual chronic pain care delivered in an academic pain clinic environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief mindfulness | Behavioral | Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. | Change from baseline to 20 minutes later. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain unpleasantness | Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | Change from baseline to 20 minutes later. |
| Positive affect |
| Measure | Description | Time Frame |
|---|---|---|
| Decentering | Three items from the The Metacognitive Processes of Decentering Scale rated on a numeric rating scale ranging from 0-10, with 0 indicating no decentering and 10 representing very high levels of decentering. | Change from baseline to 20 minutes later. |
| Self-transcendence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmytro Dmytriiev, MD | Contact | 380-432-570-360 | mddmytriiev@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinnitsa National Medical University | Recruiting | Vinnitsa | Ukraine |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual care | Other | Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics. |
|
Single numeric rating scale ranging from 0-10, with 0 indicating no positive affect and 10 representing very high levels of positive affect.
| Change from baseline to 20 minutes later. |
| Desire for analgesic medication | Single numeric rating scale ranging from 0-10, with 0 indicating no medication desire and 10 representing very high levels of medication desire. | Change from baseline to 20 minutes later. |
| Anxiety | Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety. | Change from baseline to 20 minutes later. |
| Depression | Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression. | Change from baseline to 20 minutes later. |
Three items from the Nondual Awareness Dimensional Assessment rated on a numeric rating scale ranging from 0-10, with 0 indicating no transcendence and 10 representing very high levels of transcendence. |
| Change from baseline to 20 minutes later. |