Virtual Reality (VR) Self-Hypnosis Software

An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Pain; Neuralgia; Neuropathic Pain
• Intervention / Treatment: Device: Virtual Reality headset

Detailed Description

The study will be done in two phases - Phase A is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. Testing will occur with only the study team. No participants will be involved in the testing phase. Phase B is the participant enrollment phase targeted to start 5/20/2024. A request for FDA Exemption of a non-significant risk combination device has been submitted and granted.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Catherine George, PhD; Phone Number: 646-808-6231; Email: mary-catherine.george@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Mary Catherine George, PhD; Phone Number: 646-808-6231; Email: mary-catherine.george@mssm.edu
      • Contact: Shatabdi Joshi, MS; Phone Number: 212-241-9951; Email: shatabdi.joshi@mssm.edu
      • Sub-Investigator: 'David Dorfman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Eligibility

Inclusion Criteria:

• Adults age ≥18
• Confirmed diagnosis of HIV, currently on a stable antiretroviral regimen ≥ 90 days.
• Documentation of chronic pain associated with HIV for≥90 days
• Stable pain management regimen ≥90 days, or no pain treatments ≥90 days
• Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2
• Access to the internet via smartphone, computer, or tablet 7. Fluent in English
• Capable of giving informed consent and willingness to comply with study procedures.

Exclusion Criteria:

• A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.
• Concurrent participation in another investigational protocol for pain treatment
• A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the PI, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures.
• Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.
• A medical condition predisposing prospective participant to nausea or dizziness 6. Lack of stereoscopic vision or severe hearing impairment
• Injury to eyes, face, or neck that impedes using the VR device
• If participant has access to personal VR gear for gaming or other purposes at home, participant fails to agree not to use these personal VR gear during the course of the protocol.
• Currently pregnant or planning to become pregnant during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HIV-associated Chronic Pain Patients; The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.	Device: Virtual Reality headset; Self-hypnosis software in a Virtual Reality headset. This is the development of software that provides a self-hypnosis experience that can be inserted into any virtual reality device.; Other Names: OculusGo™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times the software is used	Feasibility of self-hypnosis software using VR devices as measured by frequency of use. The device software will have an ability to determine the number of times each participant used the self-hypnosis software during the 21-day period.	twenty one days
Number of adverse events related to the device	Safety will be measured by any adverse events related to the use of the software and the device.	twenty one days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)	Participants perception of pain and quality of life will be measured using the Pain, Enjoyment and General Activity Scale (PEG). The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3-item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10, full scale ranges 0 (no pain) to 10 (most severe pain), with higher scores indicate higher levels of pain.	at Week 2, 3 and week 4
Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale	Participants perception of pain and quality of life will be measured using the Short Form Brief Pain Inventory (SF-BPI) Scale. BPI-SF is a 9-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine", thus, higher scores indicate worse health outcomes.	at Week 2, 3 and week 4

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Self-hypnosis; HIV chronic pain; virtual reality software; non-drug treatment for chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Neuralgia
• Other Study ID Numbers: STUDY-23-00989; GCO#21-1216 (Other Grant/Funding Number: i Prism Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be determined).

• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No