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Behavioural Intervention

Virtual Reality Self-Hypnosis for Pain Relief

N/A
Waitlist Available
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2
Documentation of chronic pain associated with HIV for ≥90 days
Must not have
Injury to eyes, face, or neck that impedes using the VR device
Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 2, 3 and week 4
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether a self-hypnosis software, used with a virtual reality device, can help to relieve pain in HIV patients. The study will assess the safety, usability, and effectiveness

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this involves non-invasive VR technology, side effects may include dizziness or nausea due to virtual reality immersion but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My average pain level is 3 or higher on a scale of 0-10.
Select...
I have had chronic pain related to HIV for at least 90 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an injury to my eyes, face, or neck that prevents me from using VR devices.
Select...
I have never been diagnosed with epilepsy, migraines, or other conditions that prevent me from using VR devices.
Select...
I either can't see in 3D or have severe hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 2, 3 and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 2, 3 and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of adverse events related to the device
Number of times the software is used
Secondary study objectives
Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG)
Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HIV-associated Chronic Pain PatientsExperimental Treatment1 Intervention
The participants will be enrolled into an open label arm to determine feasibility and useability of the combination device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality headset
2017
N/A
~50

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,796 Total Patients Enrolled
1 Trials studying Musculoskeletal Pain
191 Patients Enrolled for Musculoskeletal Pain
~17 spots leftby Apr 2025
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