Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA

NCT05468398 | Completed Results DMC FDA Device

• 1 other identifier: 20206207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study team aims to investigate whether implementing virtual reality therapy (VRT) during Genicular nerve radiofrequency ablation (GNRFA) procedure will provide better alleviation of procedural pain and augmented satisfaction for patients.

Conditions

Pain; Patient Satisfaction

Keywords

Genicular Nerve Block; Virtual Reality; Genicular Nerve Radiofrequency Ablation; GNRFA

Outcome Measures

Primary Outcomes (2)

• Peak Pain Intensity During Genicular RFA Procedure

  Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Visual Analog Scale (VAS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).

  20 minutes

• Patient Satisfaction With VR Device

  Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Visual Analog Scale (VAS). Participants rated their overall satisfaction immediately following the procedure on a continuous scale ranging from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome.

  Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)

Secondary Outcomes (8)

• Patient Anxiety During Genicular RFA Procedure

  During the genicular RFA procedure (approximately 20 minutes)

• Provider Satisfaction During Procedure

  Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)

• Use of Additional Local Anesthetic During Genicular RFA Procedure

  During the genicular RFA procedure (approximately 20 minutes)

• Provider Perception of Patient's Pain During Genicular RFA Procedure

  During the genicular RFA procedure (approximately 20 minutes)

• Prior Knee Radiofrequency Ablation

  Assessed at baseline (participant history of knee RFA within the past 2 years)

Study Arms (2)

Control

NO INTERVENTION

The control group will receive a genicular RFA with local anesthetic as per the standard-of-care

VR Intervention

EXPERIMENTAL

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.

Device: Soothe VR

Interventions

Soothe VR DEVICE

The Soothe VR system is manufactured by Applied VR. It is a HIPAA-compliant platform and has been validated by randomized control trials. It has not yet been reviewed by the FDA.

VR Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older
• Patients Undergoing a genicular nerve radiofrequency ablation
• Patients who have previously received nerve blocks or radiofrequency ablation procedures may be included

You may not qualify if:

• Requiring sedation during procedure
• Cognitive impairment or dementia
• History of recent stroke, epilepsy, psychosis, or claustrophobia
• Blindness or deafness
• Refusal to use the headset
• Isolation status for infection control
• Motion sickness or active nausea/vomit
• Pregnancy (Pregnancy testing point of care available for females of child bearing age)

Sponsors & Collaborators

• University of California, Irvine: lead
• Applied VR: collaborator

Study Sites (1)

UC Irvine Gottschalk Medical Plaza

Irvine, California, 92617, United States

Location

Related Publications (14)

• Alaterre C, Duceau B, Sung Tsai E, Zriouel S, Bonnet F, Lescot T, Verdonk F. Virtual Reality for PEripheral Regional Anesthesia (VR-PERLA Study). J Clin Med. 2020 Jan 13;9(1):215. doi: 10.3390/jcm9010215.

  PMID: 31941129 BACKGROUND

• Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.

  PMID: 31333900 BACKGROUND

• Jamison DE, Cohen SP. Radiofrequency techniques to treat chronic knee pain: a comprehensive review of anatomy, effectiveness, treatment parameters, and patient selection. J Pain Res. 2018 Sep 18;11:1879-1888. doi: 10.2147/JPR.S144633. eCollection 2018.

  PMID: 30271194 BACKGROUND

• Hong T, Wang H, Li G, Yao P, Ding Y. Systematic Review and Meta-Analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function. Biomed Res Int. 2019 Jun 26;2019:9037510. doi: 10.1155/2019/9037510. eCollection 2019.

  PMID: 31346525 BACKGROUND

• Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.

  PMID: 28598921 BACKGROUND

• McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.

  PMID: 6399756 BACKGROUND

• Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.

  PMID: 19272275 BACKGROUND

• Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.

  PMID: 17074626 BACKGROUND

• Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.

  PMID: 19377147 BACKGROUND

• Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3.

  PMID: 19692911 BACKGROUND

• Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004.

  PMID: 18036981 BACKGROUND

• Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.

  PMID: 31412029 BACKGROUND

• Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual Reality-Assisted Pain, Anxiety, and Anger Management in the Emergency Department. Telemed J E Health. 2019 Dec;25(12):1207-1215. doi: 10.1089/tmj.2018.0273. Epub 2019 Feb 20.

  PMID: 30785860 BACKGROUND

• Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.

  PMID: 29053848 BACKGROUND

Related Links

• Applied VR Research Studies

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This was a single-site, randomized but non-blinded pilot study with a relatively small sample size, which may limit generalizability. Participants and providers were aware of group assignments when the VR device was applied. Self-reported measures and a study pause due to COVID-19 may have impacted data consistency.

Results Point of Contact

• Title: Navid Alem, MD / Principal Investigator
• Organization: University of California, Irvine

alemn@hs.uci.edu

(949) 413-4950

Study Officials

• Navid Alem, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: This was a single-center, non-blinded, randomized controlled trial with a parallel assignment design. Participants were randomly allocated in a 1:1 ratio to receive either standard care alone or standard care with immersive virtual reality (VR) therapy during genicular nerve radiofrequency ablation (GNRFA). The intervention was administered during the procedure only. The study aimed to assess the impact of VR on patient-reported pain, anxiety, satisfaction, and physician-rated procedural outcomes.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: July 21, 2022
• Study Start: December 2, 2020
• Primary Completion: September 6, 2024
• Study Completion: December 14, 2024
• Last Updated: May 22, 2026
• Results First Posted: July 4, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)