Virtual Reality Self-Hypnosis for Pain Relief

Overseen By Mary Catherine George, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Antiretrovirals

Disqualifiers: Epilepsy, Seizure disorder, Dementia, others

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

Compensation: Varies

Number of Visits: 2

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests virtual reality (VR) software that uses self-hypnosis to relieve pain in individuals with HIV-related chronic pain. Researchers aim to determine if the software is safe, easy to use, and effective. It is ideal for those who have managed their HIV and pain steadily for at least 90 days, experience significant daily pain, and have internet access. Participants should not have conditions like epilepsy or use personal VR devices at home during the trial.

As an unphased trial, this study provides a unique opportunity to explore innovative pain management solutions.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, it requires that you have been on a stable antiretroviral and pain management regimen for at least 90 days, so you may need to continue your current medications.

What prior data suggests that this VR self-hypnosis software is safe for pain relief in HIV-associated chronic pain patients?

Research on Virtual Reality Hypnosis (VRH) for pain management shows it is generally safe. Studies have found that it can lower pain levels without causing serious side effects, indicating most people tolerate it well. VRH has been applied in various situations and has not been associated with major negative effects. Users of this technology for pain relief often report improvement without significant issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality (VR) Self-Hypnosis for pain relief in HIV-associated chronic pain because it offers a unique, drug-free approach. Unlike standard treatments like opioids or other pain medications, which can have significant side effects and potential for addiction, this method leverages immersive VR technology to help patients manage their pain through guided self-hypnosis. This innovative approach aims to empower patients with an effective tool that reduces reliance on medication and enhances their quality of life. By combining the engaging nature of VR with the therapeutic effects of hypnosis, this treatment could revolutionize how chronic pain is managed, offering a new pathway for relief without the typical risks associated with pharmaceutical interventions.

What evidence suggests that this VR self-hypnosis software is effective for pain relief in HIV-associated chronic pain patients?

Research has shown that virtual reality (VR) combined with self-hypnosis can relieve pain. Studies have found that this method significantly reduces pain levels. In this trial, participants with chronic pain related to HIV will use VR self-hypnosis as a non-drug option, providing an alternative to medication. Early results suggest that patients experience less pain and increased comfort after using VR self-hypnosis. This technique helps the brain manage pain perception, making it a promising tool for those with chronic pain. Overall, VR self-hypnosis is emerging as an effective way to relieve pain without traditional painkillers. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain related to HIV, including musculoskeletal and neuropathic pain. Participants should be comfortable using a VR headset as part of the treatment process.

Inclusion Criteria

Fluent in English

I have been on HIV medication for at least 90 days without changes.

My average pain level is 3 or higher on a scale of 0-10.

Exclusion Criteria

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

I have an injury to my eyes, face, or neck that prevents me from using VR devices.

Currently pregnant or planning to become pregnant during the study period

Timeline for a Trial Participant

Development

Development of the self-hypnosis software by the study team and engineers

Until 4/15/2024

Participant Enrollment

Participants are enrolled to test the feasibility and usability of the VR self-hypnosis software

21 days

Participants use the software at their convenience

Follow-up

Participants are monitored for safety and effectiveness after using the software

4 weeks

Assessments at Week 2, 3, and 4

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality (VR) Self-Hypnosis Software

Trial Overview

The study tests a self-hypnosis software delivered through an OculusGo™ VR device, aiming to assess its safety, ease of use, and initial effectiveness in managing HIV-associated chronic pain.

How Is the Trial Designed?

Group I: HIV-associated Chronic Pain Patients Experimental Treatment 1 Intervention

The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study involving healthy volunteers aged 18-20, participants using High Tech virtual reality (VR) reported a stronger sense of immersion and significantly greater pain reduction compared to those using Low Tech VR, with reductions of 3.1 vs. 0.7 in worst pain ratings.

The effectiveness of VR in reducing pain was positively correlated with the level of immersion experienced, suggesting that enhancing the illusion of being in a virtual world can improve pain distraction during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating presence influences the magnitude of virtual reality analgesia. Hoffman, HG., Sharar, SR., Coda, B., et al.[2008]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06398847

NCT06398847 | Virtual Reality (VR) Self-Hypnosis Software

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 ...

2.

withpower.com

withpower.com/trial/phase-musculoskeletal-pain-4-2024-d0c56

Virtual Reality Self-Hypnosis for Pain Relief

This trial is for individuals with chronic pain related to HIV, including musculoskeletal and neuropathic pain. Participants should be comfortable using a VR ...

3.

app.trialscreen.org

app.trialscreen.org/trials/virtual-reality-vr-self-hypnosis-software-trial-nct06398847

Virtual Reality (VR) Self-Hypnosis Software

Participants in this study will have the opportunity to try a potentially effective non-pharmacological approach to managing chronic pain. Their involvement ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10091709/

Virtual reality hypnosis in the management of pain

The aim of this study was to measure the effects of VRH on pain, combining neurophysiological and self‐reported measurements.

5.

ctv.veeva.com

ctv.veeva.com/study/virtual-reality-vr-self-hypnosis-software

Virtual Reality (VR) Self-Hypnosis Software

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 ...