Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA
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|ClinicalTrials.gov Identifier: NCT05468398|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pain Patient Satisfaction||Device: Soothe VR||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||January 30, 2024|
No Intervention: Control
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
Experimental: VR Intervention
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.
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.
- Peak Pain During Procedure [ Time Frame: 20 minutes ]The pain score identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied
- Patient Satisfaction with VR Device [ Time Frame: 20 minutes ]Identified intensity on a 0-100 Graphic Rating Scale questioning overall satisfaction during genicular RFA procedure with 0=not satisfied and 100= very satisfied
- Pain Thoughts: Duration of Time Patient Spent Thinking of Pain [ Time Frame: 20 minutes ]identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied
- Patient Procedural Anxiety [ Time Frame: 20 minutes ]Patient asked pre and periprocedurally, their anxiety level; measured by a 0-10 Graphic Rating scale questioning anxiety before and during procedur with 0=not anxious and 10=very anxious
- Provider Satisfaction During Procedure [ Time Frame: 20 minutes ]Practitioners' satisfaction with the VR will be assessed via a 0-100 point Graphic Rating Scale with 0=not satisfied and 100=very satisfied
- Additional Local Anesthetic [ Time Frame: 20 minutes ]Needs to Utilize Additional Local Anesthetic
- Provider Pain Perception of Patient's Pain [ Time Frame: 20 minutes ]Need for provider to utilized additional local anesthetic as measured by yes/n o and amount of additional local anesthetic utilized
- Prior Knee Radiofrequency Ablation [ Time Frame: 2 years ]Yes/No question if patient has had a previous RFA procedure prior to study visit
- Prior Virtual Reality Use [ Time Frame: 2 years ]Yes/No question if patient has used VR of any kind in the past (such as for gaming, etc.)
- Side Effects of Virtual Reality [ Time Frame: 20 minutes ]Patient will be asked if they had any side effects such as headache, palpitations, etc. when using the VR
- Subgroup Analysis [ Time Frame: 1 year ]Analysis of Patients by Age, Gender, Provider, and Technology Acceptance; reviewing demographic information across patients to determine commonalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468398
|United States, California|
|UC Irvine Gottschalk Medical Plaza|
|Irvine, California, United States, 92617|
|Principal Investigator:||Navid Alem, MD||Faculty|