Brief Mindfulness Intervention for Chronic Pain in Ukraine

NCT ID: NCT05383157

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-18

Study Completion Date

2027-12-30

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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brief mindfulness

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

Group Type EXPERIMENTAL

Brief mindfulness

Intervention Type BEHAVIORAL

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

Usual care

Intervention Type OTHER

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

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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Brief mindfulness

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

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vinnitsa National Medical University

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Eric Garland

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vinnitsa National Medical University

Vinnitsa, , Ukraine

Site Status RECRUITING

Countries

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Ukraine

Central Contacts

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Dmytro Dmytriiev, MD

Role: CONTACT

380-432-570-360

Facility Contacts

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Dmytro Dmytriiev

Role: primary

Other Identifiers

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0122U002551

Identifier Type: -

Identifier Source: org_study_id

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