PainNCT05939843
Brief Mindfulness for Foot and Ankle Pain
A study testing Pain Coping Information, Mindfulness Practice (alone) and Mindfulness Introduction + Mindfulness Practice in people with Pain, run by University of Utah at 1 site in United States.
Trial summary
This is a single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain Coping Information, Mindfulness Practice (alone) and Mindfulness Introduction + Mindfulness Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18
- Seeking foot or ankle treatment at the University Orthopaedic Center
Who cannot join
- Cognitive impairment preventing completion of study procedures.
- Current cancer diagnosis,
- Other unstable illness judged by medical staff to interfere with study involvement.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation.
- Conditions
- Pain
- Being tested
- Pain Coping Information, Mindfulness Practice (alone), Mindfulness Introduction + Mindfulness Practice, Pain Introduction + Mindfulness Introduction + Mindfulness Practice
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coping InformationBehavioural
A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)
Mindfulness Practice (alone)Behavioural
A 3-minute audio-guided mindfulness practice.
Mindfulness Introduction + Mindfulness PracticeBehavioural
A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice
Pain Introduction + Mindfulness Introduction + Mindfulness PracticeBehavioural
A 1-minute audio-recorded introduction to pain, followed by a 1-minute audio-recorded introduction the practice of mindfulness, followed by a 1-minute audio-guided mindfulness practice
| Study group | Role | What they receive |
|---|---|---|
| Pain Coping Information | Active comparator | Not described Receives: Behavioral: Pain Coping Information |
| Mindfulness Practice (alone) | Experimental | Not described Receives: Behavioral: Mindfulness Practice (alone) |
| Mindfulness Introduction + Mindfulness Practice | Experimental | Not described Receives: Behavioral: Mindfulness Introduction + Mindfulness Practice |
| Pain Introduction + Mindfulness Introduction + Mindfulness Practice | Experimental | Not described Receives: Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Unpleasantness Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Measured: Immediately before to after 3-minute audio recording
Secondary outcomes (2)
Change in Pain Intensity Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Measured: Immediately before to after 3-minute audio recording
Change in Pain Medication Desire Numeric Rating Scale
Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
Measured: Immediately before to after 3-minute audio recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start12 Jul 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939843
- Sponsor's protocol ID
- IRB_00085446 2
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness for Foot and Ankle Pain
- ClinicalTrials.gov ID
- NCT05939843
- Acronym / sponsor ID
- IRB_00085446 2
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 11 Jul 2023 (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 single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pain Coping Information | Active comparator | Behavioral: Pain Coping Information |
| Mindfulness Practice (alone) | Experimental | Behavioral: Mindfulness Practice (alone) |
| Mindfulness Introduction + Mindfulness Practice | Experimental | Behavioral: Mindfulness Introduction + Mindfulness Practice |
| Pain Introduction + Mindfulness Introduction + Mindfulness Practice | Experimental | Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- Seeking foot or ankle treatment at the University Orthopaedic Center
Key exclusion criteria (3 listed)
- Cognitive impairment preventing completion of study procedures.
- Current cancer diagnosis,
- Other unstable illness judged by medical staff to interfere with study involvement.
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 |
|---|---|---|
| Pain Coping InformationA three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery) | Behavioural | Pain Coping Information |
| Mindfulness Practice (alone)A 3-minute audio-guided mindfulness practice. | Behavioural | Mindfulness Practice (alone) |
| Mindfulness Introduction + Mindfulness PracticeA 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice | Behavioural | Mindfulness Introduction + Mindfulness Practice |
| Pain Introduction + Mindfulness Introduction + Mindfulness PracticeA 1-minute audio-recorded introduction to pain, followed by a 1-minute audio-recorded introduction the practice of mindfulness, followed by a 1-minute audio-guided mindfulness practice | Behavioural | Pain Introduction + Mindfulness Introduction + Mindfulness Practice |
Primary outcome
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately before to after 3-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
2 secondary outcomes
Change in Pain Intensity Numeric Rating Scale
Time frame: Immediately before to after 3-minute audio recording
Change in Pain Medication Desire Numeric Rating Scale
Time frame: Immediately before to after 3-minute audio recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Coping Information, Mindfulness Practice (alone) and Mindfulness Introduction + Mindfulness Practice in people with Pain, run by University of Utah at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jun 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Unpleasantness Numeric Rating Scale (time frame: Immediately before to after 3-minute audio recording). 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 19 Jun 2025.