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Virtual Reality Therapy for Pain Management During Medical Procedures

N/A
Recruiting
Led By Navid Alem, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether VRT can help manage pain and improve satisfaction for patients during a GNRFA procedure.

Who is the study for?
This trial is for adults over 18 who are undergoing a genicular nerve radiofrequency ablation, including those with past nerve blocks or similar procedures. It's not suitable for pregnant women, individuals with infections requiring isolation, blindness, deafness, severe motion sickness or nausea/vomiting, refusal to use VR headsets, need for sedation during the procedure, cognitive impairments like dementia or recent stroke/epilepsy/psychosis/claustrophobia.
What is being tested?
The study is testing 'Soothe VR', a virtual reality therapy during GNRFA procedures to see if it reduces pain and increases patient satisfaction compared to standard care without VR.
What are the potential side effects?
While Soothe VR itself may not have direct side effects like medications do; users might experience discomfort such as dizziness or nausea from using the headset especially if they're prone to motion sickness.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Satisfaction with VR Device
Peak Pain During Procedure
Secondary study objectives
Additional Local Anesthetic
Pain Thoughts: Duration of Time Patient Spent Thinking of Pain
Patient Procedural Anxiety
+6 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VR InterventionExperimental Treatment1 Intervention
The VR Intervention group will receive a genicular RFA with local anesthetic as per the standard-of-care and the use of the Soothe VR device.
Group II: ControlActive Control1 Intervention
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
564 Previous Clinical Trials
1,932,529 Total Patients Enrolled
4 Trials studying Pain
1,928 Patients Enrolled for Pain
Applied VRUNKNOWN
Navid Alem, MDPrincipal InvestigatorFaculty

Media Library

Soothe VR Clinical Trial Eligibility Overview. Trial Name: NCT05468398 — N/A
Pain Research Study Groups: VR Intervention, Control
Pain Clinical Trial 2023: Soothe VR Highlights & Side Effects. Trial Name: NCT05468398 — N/A
Soothe VR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05468398 — N/A
~14 spots leftby Nov 2025
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