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 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.

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.

Is Virtual Reality Self-Hypnosis safe for humans?

Research on Virtual Reality Hypnosis (VRH) for pain management suggests it is generally safe for humans, with studies showing it can reduce pain intensity and anxiety without significant adverse effects. However, more research is needed to confirm its safety across different conditions and populations. ^{1 2 3 4 5}

How does Virtual Reality Self-Hypnosis for Pain Relief differ from other pain relief treatments?

Virtual Reality Self-Hypnosis is unique because it combines immersive virtual reality technology with hypnosis to manage pain, offering a non-drug approach that can be effective even for those who are less susceptible to traditional hypnosis. This method uses a virtual environment to guide patients through hypnotic processes, potentially reducing the need for extensive clinician training and making it more accessible than traditional hypnosis. ^{3 4 5 6 7}

What data supports the effectiveness of the treatment Virtual Reality Self-Hypnosis Software for pain relief?

Research shows that combining virtual reality with hypnosis can help reduce pain intensity and unpleasantness, as seen in studies with trauma and burn patients. This approach may make hypnosis more accessible and effective by using immersive technology to guide patients through pain management. ^{3 4 5 8 9}

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. England pubmed.ncbi.nlm.nih.gov

VIRTUAL REALITY HYPNOSIS. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Virtual reality hypnosis for pain associated with recovery from physical trauma. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Hypnosis Associated with 3D Immersive Virtual Reality Technology in the Management of Pain: A Review of the Literature. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Hypnosis delivered through immersive virtual reality for burn pain: A clinical case series. [2011]

5. England pubmed.ncbi.nlm.nih.gov

Virtual reality hypnosis: a case report. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Manipulating presence influences the magnitude of virtual reality analgesia. [2008]

7. Canada pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Hypnosis on Pain Threshold and Neurophysiological and Autonomic Biomarkers in Healthy Volunteers: Prospective Randomized Crossover Study. [2022]

8. Israel pubmed.ncbi.nlm.nih.gov

Virtual reality immersion method of distraction to control experimental ischemic pain. [2011]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual reality hypnosis diminishes experimental cold pain and alters autonomic responses. [2023]