NCT05468398

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	Soothe VR	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.

Timeline

• Start date: 2020-12-02
• Primary completion: 2024-09-06
• Completion: 2024-12-14
• First posted: 2022-07-21
• Last updated: 2025-07-04
• Results posted: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study