NCT05383157

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
20mo left

Started May 2022

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
May 2022Dec 2027

First Submitted

Initial submission to the registry

May 16, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

5.6 years

First QC Date

May 16, 2022

Last Update Submit

March 26, 2025

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain unpleasantness

    Change from baseline to 20 minutes later.

  • Positive affect

    Change from baseline to 20 minutes later.

  • Desire for analgesic medication

    Change from baseline to 20 minutes later.

  • Anxiety

    Change from baseline to 20 minutes later.

  • Depression

    Change from baseline to 20 minutes later.

Other Outcomes (2)

  • Decentering

    Change from baseline to 20 minutes later.

  • Self-transcendence

    Change from baseline to 20 minutes later.

Study Arms (2)

Brief mindfulness

EXPERIMENTAL

A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques.

Behavioral: Brief mindfulnessOther: Usual care

Usual care

ACTIVE COMPARATOR

15 minutes of usual chronic pain care delivered in an academic pain clinic environment.

Other: Usual care

Interventions

Brief mindfulnessBEHAVIORAL

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

Brief mindfulness
Usual careOTHER

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

Brief mindfulnessUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician-confirmed chronic pain-related diagnosis

You may not qualify if:

  • Cognitive impairment preventing completion of study procedures.
  • Other unstable illness judged by medical staff to interfere with study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinnitsa National Medical University

Vinnitsa, Ukraine

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dmytro Dmytriiev, MD

CONTACT

380-432-570-360mddmytriiev@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 19, 2022

Study Start

May 18, 2022

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

UA(1)