Brief Mindfulness Intervention for Chronic Pain in Ukraine

Chronic Pain Clinical Trial

Official title:

Brief Mindfulness Intervention for Chronic Pain in Ukraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383157
• Other study ID #: 0122U002551
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: Dmytro Dmytriiev, MD
• Phone: 380-432-570-360
• Email: mddmytriiev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Brief mindfulness
Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.

Other:
• Usual care
Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.

Locations

Country	Name	City	State
Ukraine	Vinnitsa National Medical University	Vinnitsa

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Vinnitsa National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Self-transcendence	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.