Brief Mindfulness Intervention for Chronic Pain in Ukraine

Study Overview
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Brief Summary
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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.

Official Title
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Brief Mindfulness Intervention for Chronic Pain in Ukraine

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Brief mindfulness
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief mindfulness<br>A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques. | Behavioral: Brief mindfulness<br>* Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.<br>Other: Usual care<br>* Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.<br>|
| Active Comparator: Usual care<br>15 minutes of usual chronic pain care delivered in an academic pain clinic environment. | Other: Usual care<br>* Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |