Back to resultsBrief Mindfulness Intervention for Chronic Pain in Ukraine
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Brief mindfulness
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
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.
Sites / Locations
- Vinnitsa National Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brief mindfulness
Usual care
Arm Description
A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques.
15 minutes of usual chronic pain care delivered in an academic pain clinic environment.
Outcomes
Primary Outcome Measures
Pain intensity
Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Secondary Outcome Measures
Pain unpleasantness
Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
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.
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.
Anxiety
Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety.
Depression
Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression.
Full Information
NCT ID
NCT05383157
First Posted
May 16, 2022
Last Updated
July 3, 2023
Sponsor
University of Utah
Collaborators
Vinnitsa National Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05383157
Brief Title
Brief Mindfulness Intervention for Chronic Pain in Ukraine
Official Title
Brief Mindfulness Intervention for Chronic Pain in Ukraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Vinnitsa National Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief mindfulness
Arm Type
Experimental
Arm Description
A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
15 minutes of usual chronic pain care delivered in an academic pain clinic environment.
Intervention Type
Behavioral
Intervention Name(s)
Brief mindfulness
Intervention Description
Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Time Frame
Change from baseline to 20 minutes later.
Secondary Outcome Measure Information:
Title
Pain unpleasantness
Description
Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Time Frame
Change from baseline to 20 minutes later.
Title
Positive affect
Description
Single numeric rating scale ranging from 0-10, with 0 indicating no positive affect and 10 representing very high levels of positive affect.
Time Frame
Change from baseline to 20 minutes later.
Title
Desire for analgesic medication
Description
Single numeric rating scale ranging from 0-10, with 0 indicating no medication desire and 10 representing very high levels of medication desire.
Time Frame
Change from baseline to 20 minutes later.
Title
Anxiety
Description
Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety.
Time Frame
Change from baseline to 20 minutes later.
Title
Depression
Description
Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression.
Time Frame
Change from baseline to 20 minutes later.
Other Pre-specified Outcome Measures:
Title
Decentering
Description
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.
Time Frame
Change from baseline to 20 minutes later.
Title
Self-transcendence
Description
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.
Time Frame
Change from baseline to 20 minutes later.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmytro Dmytriiev, MD
Phone
380-432-570-360
Email
mddmytriiev@gmail.com
Facility Information:
Facility Name
Vinnitsa National Medical University
City
Vinnitsa
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmytro Dmytriiev
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Brief Mindfulness Intervention for Chronic Pain in Ukraine
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