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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary outcome measures

Patient Satisfaction with VR Device

Peak Pain During Procedure

Secondary outcome measures

Additional Local Anesthetic

Pain Thoughts: Duration of Time Patient Spent Thinking of Pain

Patient Procedural Anxiety

+6 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,976 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

Frequently Asked Questions

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

Is accrual still open for the trial participants?

"As per the details on clinicaltrials.gov, this medical trial is not currently taking part in recruitment exercises. Initially posted on December 2nd 2020, and recently updated on July 18th 2022 - it seems that no participants are being sought after at present time; however, 381 other trials are actively receiving applications from potential volunteers."

Answered by AI

What are the primary aims of this medical experiment?

"The primary outcome of this study, evaluated over a 20-minute period, is the Peak Pain During Procedure. Additionally, other secondary outcomes monitored include Provider Pain Perception of Patient's Pain (assessed through an answerable binary question and quantity of additional local anesthetic utilized), Practitioner Satisfaction during Procedure (measured on a 0 to 100 Graphic Rating Scale), and Duration of Time Patients Spent Thinking about their Pain (recorded using another 0 to 100 Graphic Rating Scale)."

Answered by AI

Recent research and studies

Archives of Physical Medicine and RehabilitationJournal

Factors Influencing the Efficacy of Virtual Reality Distraction Analgesia During Postburn Physical Therapy: Preliminary Results from 3 Ongoing Studies

Sharar, Sam R., Gretchen J. Carrougher, Dana Nakamura, Hunter G. Hoffman, David K. Blough, and David R. Patterson. 2007. “Factors Influencing the Efficacy of Virtual Reality Distraction Analgesia During Postburn Physical Therapy: Preliminary Results from 3 Ongoing Studies”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2007.09.004.

BioMed Research InternationalJournal

Systematic Review and Meta-analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function

Hong, Tao, Haiyuan Wang, Guangxiao Li, Peng Yao, and Yuanyuan Ding. 2019. “Systematic Review and Meta-analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function”. Biomed Research International. Hindawi Limited. doi:10.1155/2019/9037510.

Behaviour Research and TherapyJournal

Effects of Attentional Direction, Age, and Coping Style on Cold-pressor Pain in Children

Piira, Tiina, Brett Hayes, Belinda Goodenough, and Carl L. von Baeyer. 2006. “Effects of Attentional Direction, Age, and Coping Style on Cold-pressor Pain in Children”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/j.brat.2005.03.013.

Journal of Pain ResearchJournal