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

Not Applicable

Recruiting

• Conditions: Pain; Patient Satisfaction
• Interventions: Device: Soothe VR

• Registration Number: NCT05468398
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Patients' experience through a medical procedure in a hospital environment is inherently stressful and painful. Although virtual reality (VR) was originally recognized for its entertainment value, it has recently been used as an innovative tool in clinical settings to reduce pain and anxiety, while improving patient satisfaction. VR is a computer generated simulation of a life-like experience that usually serves people for entertainment and social interactive purposes in a simulated three-dimensional environment. Virtual reality therapy (VRT) offers patients an opportunity to "get away" from noxious stimuli as they draw their attention towards another virtual world (Alem).

Virtual reality provides a cognitive distraction through creating a "real world illusion." VR may deter an individual's attention from pain as it offers a multimodal sensory distractor. This positive experience may result in reduction of pain score by decreasing the time patients think about their pain during a procedure.

Genicular nerve radiofrequency ablation (GNRFA) is an option to treat knee pain without surgery. The genicular nerves are the nerves that feed into the knee. Radiofrequency ablation is a process by applying radiofrequency waves to the nerves that are carrying the painful impulses from the knee joint. GNRFA uses fluoroscopy guidance to introduce 3 needles at each of the three genicular nerves which transmit sensation from the knee joint. This is followed by testing for sensory response, followed by administration of local anesthetic (2% lidocaine) per standard-of-care, and then radiofrequency ablation. This method of treatment is known to be very safe, convenient and reliable because fluoroscopy guidance provides high accuracy of localization at the procedure targets outside of the knee joint. Patients with symptomatic knee osteoarthritis have shown short and long term positive results following this method with significant reduction of pain levels (Kidd) and augmented functionality. This non-invasive procedure is able to successfully replace surgery or intra-articular therapy where the procedure is conducted directly on the knee joint.

Study Timeline

• Study Start: 2020-12-02
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR Intervention	Soothe VR	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.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction with VR Device	20 minutes	Identified intensity on a 0-100 Graphic Rating Scale questioning overall satisfaction during genicular RFA procedure with 0=not satisfied and 100= very satisfied
Peak Pain During Procedure	20 minutes	The pain score identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied

Secondary Outcome Measures

Name	Time	Method
Provider Pain Perception of Patient's Pain	20 minutes	Need for provider to utilized additional local anesthetic as measured by yes/n o and amount of additional local anesthetic utilized
Provider Satisfaction During Procedure	20 minutes	Practitioners' satisfaction with the VR will be assessed via a 0-100 point Graphic Rating Scale with 0=not satisfied and 100=very satisfied
Patient Procedural Anxiety	20 minutes	Patient asked pre and periprocedurally, their anxiety level; measured by a 0-10 Graphic Rating scale questioning anxiety before and during procedur with 0=not anxious and 10=very anxious
Prior Virtual Reality Use	2 years	Yes/No question if patient has used VR of any kind in the past (such as for gaming, etc.)
Pain Thoughts: Duration of Time Patient Spent Thinking of Pain	20 minutes	identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied
Prior Knee Radiofrequency Ablation	2 years	Yes/No question if patient has had a previous RFA procedure prior to study visit
Side Effects of Virtual Reality	20 minutes	Patient will be asked if they had any side effects such as headache, palpitations, etc. when using the VR
Additional Local Anesthetic	20 minutes	Needs to Utilize Additional Local Anesthetic
Subgroup Analysis	1 year	Analysis of Patients by Age, Gender, Provider, and Technology Acceptance; reviewing demographic information across patients to determine commonalities

Trial Locations

Locations (1)

UC Irvine Gottschalk Medical Plaza; 🇺🇸 Irvine, California, United States