VR Program for Chronic Pain

(VITALS-Pain Trial)

Overseen By Ugur Yener, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Seizures, Severe motion sickness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual reality (VR) program to help manage chronic pain in individuals dealing with opioid misuse or opioid use disorder. Participants will use a VR headset for a single 45-minute session divided into three parts: an AI check-in, pain coping skills training, and stress reduction exercises. The trial aims to determine if this VR approach is practical and welcomed by users. Ideal participants have moderate or worse chronic pain, have not recently changed their pain medications, and can understand English instructions. As an unphased trial, this study offers participants the chance to explore innovative pain management techniques that could improve their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have any pain medication changes in the 14 days before joining the study.

What prior data suggests that this VR program is safe for managing chronic pain?

Research has shown that virtual reality (VR) treatments have been explored for managing pain. In past studies, most participants found VR comfortable and safe. Some common side effects include mild dizziness or nausea, similar to what some experience when using VR for video games.

For this specific VR program, the study is in its early stages, focusing on user acceptance and potential pain relief. Due to its early phase, detailed safety information for this program might not yet be available. However, the VR technology used, such as the Meta Quest 3 headset, is already popular and widely used in other areas, contributing to its safety reputation. Prospective participants should ask the study team any questions about safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VR Program for Chronic Pain because it offers a completely new way to manage chronic pain using virtual reality technology. Unlike traditional pain treatments that often rely on medications like opioids or physical therapy, this program uses AI-guided sessions to provide personalized pain management strategies. The intervention includes an AI check-in for tailored health assessments and a unique Pain Coping Skills Training session, which educates users on managing pain effectively. Additionally, the program incorporates stress reduction exercises, aiming to improve overall biopsychosocial health in just a single-day session, which is a novel approach in the field.

What evidence suggests that this VR program is effective for managing chronic pain?

Research has shown that virtual reality (VR) can help manage long-term pain. Studies have found that VR distracts people from their pain, making it feel less severe. This approach is promising because it can also boost mood and keep people engaged. In this trial, participants will experience an AI-guided Virtual Reality (VR) session, where an AI coach guides users through pain management techniques. Although data collection on this specific program is ongoing, similar VR tools have shown promise in improving patients' well-being and quality of life. Early signs suggest that VR could be a helpful addition to managing chronic pain, especially for those dealing with opioid misuse. ^{1 2 3 6 7}

Who Is on the Research Team?

Moorice A Caparo, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain who also struggle with opioid misuse or opioid use disorder. Participants should be comfortable using a VR headset and willing to attend a single-day session at the Montefiore Multidisciplinary Pain Medicine Program.

Inclusion Criteria

Ability to understand written/spoken instruction and provide informed consent in English

Ability and willingness to participate in all components of the study

Patients with opioid misuse or International Classification of Diseases 10th revision (ICD-10) diagnosis of opioid use disorder

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)

Acute exacerbation of psychiatric conditions that preclude the ability to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

VR Intervention

Participants undergo a single-day 45-minute VR intervention subdivided into three sessions: AI check-in, Pain Coping Skills Training, and stress reduction exercise

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the VR intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Intelligence for Transformative Lifestyle Solutions

Trial Overview The study tests a virtual reality (VR) intervention for managing chronic pain, which includes an AI coach check-in, pain coping skills training, and stress reduction exercises using the Meta Quest 3 VR headset.

How Is the Trial Designed?

Group I: AI-guided Virtual Reality (VR) Session Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

AugMend Health

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07124598

Study Details | NCT07124598 | Virtual Intelligence for ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07124598?lastUpdPost=2020-01-16_

Study Details | Virtual Intelligence for Transformative ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. withpower.com withpower.com/trial/phase-chronic-pain-7-2025-46c9c

VR Program for Chronic Pain · Info for Participants 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 ...

4. liebertpub.com liebertpub.com/doi/full/10.1089/jmedxr.2024.0063

The Role of Virtual Reality in Chronic Pain and Loneliness VR offers a promising approach to managing chronic pain and loneliness, with the potential to improve patient outcomes and quality of life.

5. xr.health xr.health/us/blog/pain-management-for-chronic-pain/

Chronic Pain Management: How Virtual Reality Offers New ... VR offers healthcare professionals a multifaceted approach to treating chronic pain – from improving patient engagement to providing real-time ...

6. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-virtual-intelligence-for-transformative-lifestyle-solutions-in-pain/555749987

Clinical Trial: Virtual Intelligence for Transformative ... Brief Summary: This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7523056/

Virtual reality in pain therapy: a requirements analysis for ... The aim of the study was to perform a requirements analysis for the user group of geriatric patients with CBP for a VR exergame.