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NCT Number: NCT05383157

Brief Mindfulness Intervention for Chronic Pain in Ukraine

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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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vinnitsa National Medical University

Vinnitsa, Ukraine

Location status: Recruiting

Location contact

Dmytro Dmytriiev

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Mindfulness

Behavioral

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

Usual Care

Other

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

Primary outcomes

  1. Pain intensity

    Time frame: 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 outcomes

  1. Pain unpleasantness

    Time frame: 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.

  2. Positive affect

    Time frame: 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.

  3. Desire for analgesic medication

    Time frame: 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.

  4. Anxiety

    Time frame: 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.

  5. Depression

    Time frame: 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 outcomes

  1. Decentering

    Time frame: 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.

  2. Self-transcendence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, MD

CONTACT

[email protected]

380-432-570-360

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Vinnitsa National Medical University

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 19, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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