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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation

Conditions
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Pain, Patient Satisfaction

Intervention / Treatment
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* Device: Soothe VR


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will receive a genicular RFA with local anesthetic as per the standard-of-care | |
| Experimental: VR Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Pain During Procedure | 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 | 20 minutes | 
| Patient Satisfaction with VR Device | Identified intensity on a 0-100 Graphic Rating Scale questioning overall satisfaction during genicular RFA procedure with 0=not satisfied and 100= very satisfied | 20 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genicular Nerve Block, Virtual Reality, Genicular Nerve Radiofrequency Ablation, GNRFA