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Completed NCT07124598

Virtual Intelligence for Transformative Lifestyle Solutions in Pain

Conditions: Chronic Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Montefiore Medical Center

Location: Montefiore Multidisciplinary Pain Medicine Program (MMPP) at Montefiore Einstein Hutchinson Campus The Bronx New York

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07124598). StuddyBuddy aggregates publicly available trial information.