Virtual Intelligence for Transformative Lifestyle Solutions in Pain (NCT07124598) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Intelligence for Transformative Lifestyle Solutions in Pain
United States15 participantsStarted 2026-06
Plain-language summary
This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a virtual AI coach for patients with Opioid misuse and opioid use disorder (OM/OUD). The intervention is a single-day 45-minute VR intervention which is subdivided into three smaller sessions:
Session 1: A 15-minute AI check-in to ask questions about biopsychosocial health, Session 2: A 20-minute Pain Coping Skills Training (PCST) session offering psychoeducation on managing chronic pain Session 3: A 10-minute stress reduction exercise.
The VR sessions will be conducted using hardware (VR Headset Device - Meta Quest 3) and software developed by AugMend Health Company.
The study will be conducted in a clinical setting at the Montefiore Multidisciplinary Pain Medicine Program (MMPP), a Pain Medicine outpatient specialty practice within a major urban medical center. MMPP providers see thousands of patients every month, some of which have concurrent opioid misuse or OM/OUD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with opioid misuse or International Classification of Diseases 10th revision (ICD-10) diagnosis of opioid use disorder
* Patients with Chronic pain of at least moderate intensity (\>4 Pain Intensity Score) with no pain medication changes in 14 days
* Ability to understand written/spoken instruction and provide informed consent in English
* Ability and willingness to participate in all components of the study
Exclusion Criteria:
* History of severe motion sickness, cybersickness, or conditions that could make participation in VR hazardous or cause adverse effects
* Conditions that could prevent proper use of VR headset (such as vision problems that cannot be corrected by contact lenses or glasses that fit in VR, Significant hearing impairments that cannot be corrected by a hearing device)
* History of seizures or seizure disorder
* Acute exacerbation of psychiatric conditions such as self-injurious behaviors or suicidal risk that preclude the ability to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a feasibility study using virtual reality for chronic pain — since it's in an early phase focused on whether the approach is even workable, does that mean there's still a lot unknown about whether it actually reduces pain, and would you recommend it alongside or instead of my current pain management?
2The study is measuring things like recruitment rates and how well people complete the program — what does it mean for me practically if the researchers are still figuring out whether patients can stick with this virtual reality approach, and is there a risk I'd be in a program that gets adjusted or stopped midway?
3Since this trial involves virtual reality technology, are there any reasons related to my specific type of chronic pain, my health history, or my access to the right equipment at home that would make it hard or unsafe for me to participate?
4The trial measures 'satisfaction' and 'degree of change' rather than a direct pain score — does that mean it's not yet designed to prove whether VR actually reduces pain, and if so, what might I be giving up by not pursuing a more established treatment right now?
5Given that this is still a feasibility study recruiting participants, how would you weigh enrolling in this trial against other evidence-based options you'd recommend for my chronic pain at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility - Recruitment Rate
Timeframe: Approximately 6 months
2
Feasibility - Completion
Timeframe: Approximately 6 months
3
Feasibility - Virtual Reality Experience and Feasibility Survey (VREFS)
Timeframe: Up to 1 hour following completion of ~ 45-minute VR session
4
Acceptability - Acceptability of Intervention Measure (AIM)
Timeframe: Up to 1 hour following completion of ~ 45-minute VR session
5
Satisfaction - Change
Timeframe: Up to 1 hour following completion of ~ 45-minute VR session
6
Satisfaction - Degree of Change
Timeframe: Up to 1 hour following completion of ~ 45-minute VR session