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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness Intervention for Chronic Pain in Ukraine
- ClinicalTrials.gov ID
- NCT05383157
- Acronym / sponsor ID
- 0122U002551
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Vinnitsa National Medical University
- Study start
- 18 May 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief mindfulness | Experimental | Behavioral: Brief mindfulness, Other: Usual careA 15-minute mindfulness intervention integrating mindful breathing and mindfulness of pain techniques. |
| Usual care | Active comparator | Other: Usual care15 minutes of usual chronic pain care delivered in an academic pain clinic environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physician-confirmed chronic pain-related diagnosis
Key exclusion criteria (2 listed)
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mindfulnessTraining in mindfulness focused on breathing and pain sensations to enhance decentering, meta-awareness, and interoceptive awareness. | Behavioural | Brief mindfulness |
| Usual careUsual pain care as delivered in the clinic involving pain assessment and prescription of analgesics. | Other | Brief mindfulness, Usual care |
Primary outcome
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.
5 secondary outcomes
Pain unpleasantness
Time frame: Change from baseline to 20 minutes later.
Positive affect
Time frame: Change from baseline to 20 minutes later.
Desire for analgesic medication
Time frame: Change from baseline to 20 minutes later.
Anxiety
Time frame: Change from baseline to 20 minutes later.
Depression
Time frame: Change from baseline to 20 minutes later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mindfulness in people with Chronic Pain, run by University of Utah at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, MD (380-432-570-360, mddmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Change from baseline to 20 minutes later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.