Chronic PainNCT05383157
Brief Mindfulness Intervention for Chronic Pain in Ukraine
A study testing Brief mindfulness in people with Chronic Pain, run by University of Utah at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Brief mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 18 May 2022to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-confirmed chronic pain-related diagnosis
Who cannot join
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Vinnitsa National Medical University
Vinnitsa
Dmytro Dmytriiev
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Brief mindfulness, Usual care
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mindfulnessBehavioural
Training in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness.
Usual careOther
Usual pain care as delivered in the clinic involving pain assessment and prescription of analgesics.
| Study group | Role | What they receive |
|---|---|---|
| Brief mindfulness | Experimental | A 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques. Receives: Behavioral: Brief mindfulness; Other: Usual care |
| Usual care | Active comparator | 15 minutes of usual chronic pain care delivered in an academic pain clinic environment. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Single numeric rating scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Measured: Change from baseline to 20 minutes later.
Secondary outcomes (5)
Pain unpleasantness
Single numeric rating scale ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Measured: Change from baseline to 20 minutes later.
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.
Measured: Change from baseline to 20 minutes later.
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.
Measured: Change from baseline to 20 minutes later.
Anxiety
Single numeric rating scale ranging from 0-10, with 0 indicating no anxiety and 10 representing very high levels of anxiety.
Measured: Change from baseline to 20 minutes later.
Depression
Single numeric rating scale ranging from 0-10, with 0 indicating no depression and 10 representing very high levels of depression.
Measured: Change from baseline to 20 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start18 May 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnitsa National Medical University
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383157
- Sponsor's protocol ID
- 0122U002551
- Status last verified
- Mar 2025
- First submitted
- 16 May 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided