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Behavioural Intervention

HIV-associated Chronic Pain Patients for Musculoskeletal Pain

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 2, 3 and week 4

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I have had chronic pain related to HIV for at least 90 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ twenty one days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~twenty one days

This trial's timeline: 3 weeks for screening, Varies for treatment, and twenty one days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events related to the device

Number of times the software is used

Secondary outcome measures

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

863 Previous Clinical Trials

525,589 Total Patients Enrolled

1 Trials studying Musculoskeletal Pain

191 Patients Enrolled for Musculoskeletal Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"As per clinicaltrials.gov, this particular research is not in need of new participants. Originally uploaded on May 1st, 2024 and last revised on April 30th, 2024. Despite its closure for recruitment, there are currently 184 other ongoing studies actively seeking eligible subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality (VR) Self-Hypnosis Software

Mary Catherine George 2024. "Virtual Reality (VR) Self-Hypnosis Software". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06398847.

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