Brief Mindfulness Intervention for Chronic Pain in Ukraine

Sponsor
University of Utah (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05383157
Collaborator
Vinnitsa National Medical University (Other)
150
2
12.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief mindfulness
  • Other: Usual care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Brief Mindfulness Intervention for Chronic Pain in Ukraine
Anticipated Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brief mindfulness

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

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.

Active Comparator: Usual care

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

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

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [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 Outcome Measures

  1. Pain unpleasantness [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 [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 [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 [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 [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 Outcome Measures

  1. Decentering [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Utah
  • Vinnitsa National Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eric Garland, Distinguished Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT05383157
Other Study ID Numbers:
  • 0122U002551
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022