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临床试验/NCT05468398
NCT05468398已完成不适用

The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Patient Satisfaction With VR Device

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Control

No Intervention

The control group will receive a genicular RFA with local anesthetic as per the standard-of-care

VR Intervention

Experimental

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.

干预措施: Soothe VR (Device)

结局指标

主要结局

Patient Satisfaction With VR Device

时间窗: 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.

Peak Pain Intensity During Genicular RFA Procedure

时间窗: 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).

次要结局

  • Duration of Time Patient Spent Thinking About Pain During Genicular RFA Procedure(During the genicular RFA procedure (approximately 20 minutes))
  • Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure(During the genicular RFA procedure (approximately 20 minutes))
  • Use of Additional Local Anesthetic During Genicular RFA Procedure(During the genicular RFA procedure (approximately 20 minutes))
  • Prior Knee Radiofrequency Ablation(Assessed at baseline (participant history of knee RFA within the past 2 years))
  • Prior Experience With Virtual Reality (VR)(Assessed at baseline (participant history of VR use within the past 2 years))
  • Side Effects Associated With Virtual Reality During Genicular RFA Procedure(Immediately post-procedure (approximately 20 minutes after procedure initiation))
  • Subgroup Analysis by Age, Gender, Provider, and Technology Acceptance(Assessed at baseline (demographic information collected at enrollment))
  • Provider Satisfaction During Procedure(Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation))
  • Provider Perception of Patient's Pain During Genicular RFA Procedure(During the genicular RFA procedure (approximately 20 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Navid Alem

Associate Clinical Professor

University of California, Irvine

研究点 (2)

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