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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Enrolling

Conditions

Patient Satisfaction
Pain

Treatments

Device: Soothe VR

Study type

Interventional

Funder types

Other

Identifiers

NCT05468398
20206207

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

67 participants in 2 patient groups

Control
No Intervention group
Description:
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
VR Intervention
Experimental group
Description:
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.
Treatment:
Device: Soothe VR

Trial contacts and locations

1

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Central trial contact

Paulette Mensah, BA; Navid Alem, MD

Data sourced from clinicaltrials.gov

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