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

University of California, Irvine40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain Patient Satisfaction

Interventions

Soothe VRDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

UC Irvine Gottschalk Medical Plaza

Irvine, California, United States

Outcomes

Primary Outcomes

Peak Pain Intensity During Genicular RFA Procedure

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).

Time frame: 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 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.

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

Secondary Outcomes

Duration of Time Patient Spent Thinking About Pain During Genicular RFA Procedure

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).

Time frame: During the genicular RFA procedure (approximately 20 minutes)

Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure

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).

Data from ClinicalTrials.gov

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