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Virtual Intelligence for Transformative Lifestyle Solutions in Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Multidisciplinary Pain Medicine Program (MMPP) at Montefiore Einstein Hutchinson Campus
RECRUITING
The Bronx
Contact Information
Primary
Ugur Yener, MD
uyener@montefiore.org
(718) 405-8360
Backup
Hatice B Ciftci, MD
hciftci@montefiore.org
(718) 405-8360
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 15
Treatments
Experimental: AI-guided Virtual Reality (VR) Session
The intervention is a single-day 45-minute VR intervention which is subdivided into 3 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), AugMend Health
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov

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