Chronic Pain
Conditions
Brief summary
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.
Interventions
BEHAVIORALBrief mindfulness
Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.
OTHERUsual care
Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.
Sponsors
Vinnitsa National Medical University
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician-confirmed chronic pain-related diagnosis
Exclusion criteria
* Cognitive impairment preventing completion of study procedures. * Other unstable illness judged by medical staff to interfere with study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Change from baseline to 20 minutes later. | Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain unpleasantness | Change from baseline to 20 minutes later. | Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. |
| Positive affect | Change from baseline to 20 minutes later. | Single numeric rating scale ranging from 0-10, with 0 indicating no positive affect and 10 representing very high levels of positive affect. |
| Desire for analgesic medication | Change from baseline to 20 minutes later. | Single numeric rating scale ranging from 0-10, with 0 indicating no medication desire and 10 representing very high levels of medication desire. |
| Anxiety | Change from baseline to 20 minutes later. | Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety. |
| Depression | Change from baseline to 20 minutes later. | Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decentering | Change from baseline to 20 minutes later. | 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. |
| Self-transcendence | 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. |
Countries
Ukraine
Contacts
Primary ContactDmytro Dmytriiev, MD
Outcome results
None listed