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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468398
Recruitment Status : Active, not recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Applied VR
Information provided by (Responsible Party):
Navid Alem, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Pain Patient Satisfaction Device: Soothe VR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Additional Local Anesthetic [ Time Frame: 20 minutes ]
    Needs to Utilize Additional Local Anesthetic

  5. 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

  6. Prior Knee Radiofrequency Ablation [ Time Frame: 2 years ]
    Yes/No question if patient has had a previous RFA procedure prior to study visit

  7. 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.)

  8. 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

  9. Subgroup Analysis [ Time Frame: 1 year ]
    Analysis of Patients by Age, Gender, Provider, and Technology Acceptance; reviewing demographic information across patients to determine commonalities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Locations
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United States, California
UC Irvine Gottschalk Medical Plaza
Irvine, California, United States, 92617
Sponsors and Collaborators
University of California, Irvine
Applied VR
Investigators
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Principal Investigator: Navid Alem, MD Faculty
Additional Information:
Publications:

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Responsible Party: Navid Alem, Associate Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05468398    
Other Study ID Numbers: 2020-6207
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Navid Alem, University of California, Irvine:
Genicular Nerve Block
Virtual Reality
Genicular Nerve Radiofrequency Ablation
GNRFA