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

Not Applicable

Completed

• Conditions: Pain; Patient Satisfaction

• 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
• Primary Completion: 2024-09-06
• Study Completion: 2024-12-14
• Results First Submitted: 2025-04-25
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Results First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Primary Outcome Measures

Name	Time	Method
Peak Pain Intensity During Genicular RFA Procedure	20 minutes	Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Graphic Rating Scale (GRS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Patient Satisfaction With VR Device	Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)	Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Graphic Rating Scale (GRS). 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.

Secondary Outcome Measures

Name	Time	Method
Duration of Time Patient Spent Thinking About Pain During Genicular RFA Procedure	During the genicular RFA procedure (approximately 20 minutes)	The duration or proportion of time patients spent thinking about their pain during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Participants rated how much time they spent thinking about pain during the procedure, with scores ranging from 0 ("no time thinking about pain") to 100 ("entire procedure spent thinking about pain"). Higher scores indicate a worse outcome (greater proportion of procedure time spent thinking about pain).
Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure	During the genicular RFA procedure (approximately 20 minutes)	Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Patients rated their anxiety level during the procedure only, from 0 ("not anxious at all") to 100 ("extremely anxious"). Higher scores indicate a worse outcome (greater anxiety).
Provider Satisfaction During Procedure	Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)	Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Providers rated their overall satisfaction immediately following completion of the procedure, from 0 ("not satisfied at all") to 100 ("extremely satisfied"). Higher scores indicate greater satisfaction, representing a better outcome.
Use of Additional Local Anesthetic During Genicular RFA Procedure	During the genicular RFA procedure (approximately 20 minutes)	The need for additional local anesthetic administration during the genicular radiofrequency ablation (RFA) procedure was assessed as a binary outcome (Yes/No). Providers recorded whether additional local anesthetic was administered beyond the standard initial dose during the procedure.
Provider Perception of Patient's Pain During Genicular RFA Procedure	During the genicular RFA procedure (approximately 20 minutes)	Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Providers rated their perception of patient pain from 0 ("no perceived pain") to 100 ("extremely severe pain"). Higher scores indicate a worse outcome (higher perceived patient pain).
Prior Knee Radiofrequency Ablation	Assessed at baseline (participant history of knee RFA within the past 2 years)	Participants were asked if they had undergone a previous knee radiofrequency ablation (RFA) procedure prior to the study intervention. Responses were recorded as binary outcomes (Yes/No).
Prior Experience With Virtual Reality (VR)	Assessed at baseline (participant history of VR use within the past 2 years)	Participants reported if they had previously used Virtual Reality (VR) technology for any reason (e.g., gaming, therapy) before participation in the study. Responses were recorded as binary outcomes (Yes/No).
Side Effects Associated With Virtual Reality During Genicular RFA Procedure	Immediately post-procedure (approximately 20 minutes after procedure initiation)	Participants were asked immediately after the procedure if they experienced any side effects related to the use of Virtual Reality (VR), such as headache, dizziness, nausea, or palpitations. Responses were recorded as binary outcomes (Yes/No).
Subgroup Analysis by Age, Gender, Provider, and Technology Acceptance	Assessed at baseline (demographic information collected at enrollment)	A descriptive subgroup analysis of participants was conducted to identify commonalities in response and acceptance of technology across demographic characteristics including age, gender, provider type, and general acceptance of technology.

Trial Locations

Locations (1)

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