Clinical trial NCT05468398: Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA
Official title: The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Patient Satisfaction
Keywords: Genicular Nerve Block
Virtual Reality
Genicular Nerve Radiofrequency Ablation
GNRFA
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Applied VR
First posted: 2022-07-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Peak Pain During Procedure
timeFrame: 20 minutes
measure: Patient Satisfaction with VR Device
timeFrame: 20 minutes
Secondary outcomes:
measure: Pain Thoughts: Duration of Time Patient Spent Thinking of Pain
timeFrame: 20 minutes
measure: Patient Procedural Anxiety
timeFrame: 20 minutes
measure: Provider Satisfaction During Procedure
timeFrame: 20 minutes
measure: Additional Local Anesthetic
timeFrame: 20 minutes
measure: Provider Pain Perception of Patient's Pain
timeFrame: 20 minutes
measure: Prior Knee Radiofrequency Ablation
timeFrame: 2 years
measure: Prior Virtual Reality Use
timeFrame: 2 years
measure: Side Effects of Virtual Reality
timeFrame: 20 minutes
measure: Subgroup Analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Gottschalk Medical Plaza
state: California
Study officials:
affiliation: Faculty
name: Navid Alem, MD
role: PRINCIPAL_INVESTIGATOR
References:
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