UC Irvine Gottschalk Medical Plaza
Irvine, California, 92617, United States
NCT Number: NCT05468398
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Irvine, California, 92617, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 20 minutes
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Visual Analog Scale (VAS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Time frame: 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 Visual Analog Scale (VAS). 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: During the genicular RFA procedure (approximately 20 minutes)
Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 VAS. 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).
Time frame: 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 satisfaction VAS. 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.
Time frame: 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.
Time frame: 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 VAS. 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: During genicular RFA procedure (intra-procedural)
This outcome was pre-specified in the study protocol but was not collected during the study due to an omission in data collection implementation. As a result, no data are available for this outcome, and it was not analyzed.
University of California, Irvine
Other
The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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