Virtual Intelligence for Transformative Lifestyle Solutions in Pain

NCT07124598 | Not Yet Recruiting

• 2 other identifiers: 2025-16884RM1DA055437
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

Virtual Reality (VR)-based Chronic Pain Management; Opioid Management; Opioid Use Disorder; Artificial Intelligence (AI)

Outcome Measures

Primary Outcomes (6)

• Feasibility - Recruitment Rate

  Feasibility of the intervention will be assessed by tracking and determining the recruitment rate for the study. For purposes of this study recruitment rate will be defined as the number/percentage of participants who are consented, screened, and enrolled over the 6-month timeframe will be summarized and reported.

  Approximately 6 months

• Feasibility - Completion

  Feasibility of the intervention will also be assessed by the number/percentage of participants who are able to successfully complete all three AI-guided, VR sessions. The number/percentage of participants that complete all three sessions will be summarized and reported using basic descriptive statistics.

  Approximately 6 months

• Feasibility - Virtual Reality Experience and Feasibility Survey (VREFS)

  Feasibility of the intervention as assessed by VREFS will also be determined. The VREFS is a comprehensive feasibility tool which measures feasibility across 7 distinct dimensions: Core Therapeutic Alliance (6 items); Cultural Competence \& Identity (5 items); Continuity \& Future Use (3 items); Privacy \& Trust (8 items); Medical Trust (3 items); Usability (11 items); and Overall Experience (6 items). The survey also consists of 4 additional items and 6 avatar-specific items. Participants are asked to evaluate and rate each statement on a 7-point scale ranging from 1 ("Strongly disagree") to 7 ("Strongly agree") such that higher scores are associated with a more favorable assessment of the intervention and study. Results will be summarized and reported using basic descriptive statistics.

  Up to 1 hour following completion of ~ 45-minute VR session

• Acceptability - Acceptability of Intervention Measure (AIM)

  Acceptability of the intervention will be evaluated using AIM. AIM consists of 4 statements which asks participants to rate the acceptability of the intervention measures on a 5-point scale ranging from 1 ("Completely disagree") to 5 ("Completely agree") for an overall possible scoring range of 4-20, with higher scores being indicative of greater acceptability of the measures. Results will be summarized using basic descriptive statistics.

  Up to 1 hour following completion of ~ 45-minute VR session

• Satisfaction - Change

  Satisfaction will be measured and assessed using the Patient's Global Impression of Change Scale (PGIC) questionnaire completed following the VR intervention. Participants will be asked to respond to the following query, "Since beginning treatment at this clinic, how would you describe the change (if any) in Activity, Limitations, Symptoms, Emotions and Overall Quality of Life, related to your painful condition? (tick only 1 box)" on a 7-point Likert scale ranging from 1 - "No change (or condition is worse)" to 7 "A great deal better, and a considerable improvement that has made all the difference" such that higher scores are associated with improved global impression of change. Results will be summarized using basic descriptive statistics.

  Up to 1 hour following completion of ~ 45-minute VR session

• Satisfaction - Degree of Change

  Satisfaction will be also measured and assessed using the following question derived from the PGIC questionnaire: "In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic." Participants will be asked to rate the degree of change on an 11-point scale ranging from 0 ("Much better") to 10 ("Much worse") such that lower scores are associated with a worsened degree of change. Results will be summarized using basic descriptive statistics.

  Up to 1 hour following completion of ~ 45-minute VR session

Secondary Outcomes (4)

• Efficacy - Change in Pain Severity Level

  From pre- to post-VR session, up to 4 hours

• Efficacy - Change in Anxiety Level

  From pre- to post-VR session, up to 4 hours

• Efficacy - Self-efficacy in managing Drug/Opioid use and cravings

  From pre- to post-VR session, up to 4 hours

• Safety - Virtual Reality Sickness Questionnaire (VRSQ)

  Up to 1 hour following completion of ~ 45-minute VR session

Study Arms (1)

AI-guided Virtual Reality (VR) Session

EXPERIMENTAL

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.

Device: VR Headset Device - Meta Quest 3

Interventions

VR Headset Device - Meta Quest 3 DEVICE

The VR sessions will be conducted using hardware and software developed by AugMend Health Company. The AI-guided sessions will be administered using the commercially available Meta Quest 3 headset, which delivers high-resolution VR images and spatial audio through a standalone, wireless system.

AI-guided Virtual Reality (VR) Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 that preclude the ability to participate in the study

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Montefiore Medical Center: lead
• AugMend Health: collaborator

Study Sites (1)

Montefiore Multidisciplinary Pain Medicine Program (MMPP) at Montefiore Einstein Hutchinson Campus

The Bronx, New York, 10467, United States

Location

Related Publications (29)

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  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Moorice A Caparo, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugur Yener, MD

CONTACT

(718)405-8360; uyener@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study represents exploratory research comparing assessment methodologies rather than clinical implementation of a diagnostic tool. The breadth of comparison domains and focus on methodology validation supports the research-oriented, non-diagnostic nature of the application.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 15, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)