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临床试验/NCT04901793
NCT04901793已完成不适用

Efficacy of Virtual Reality in Pain Reduction in Orthopedic Pediatric Patients Measured by Patient Feedback and Heart Rate Monitoring

Ochsner Health System1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年7月1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
95
试验地点
1
主要终点
Change in Heart Rate

研究概览

简要总结

To prospectively determine if pediatric patients undergoing orthopedic procedures can benefit from employing virtual reality for pain management.

详细描述

INTRODUCTION

Pediatric patients are exposed to procedures that can result in pain and anxiety. The International Association Study of Pain 2011 defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pharmacological interventions have been used but consequences of this therapy, specifically opioids, are of concern. Distraction techniques have been implemented recently but there is a significant range of these techniques such as breathing, music, and play therapy, among others.

Some studies indicate child preferences and temperament can optimize outcomes in regards to therapy. Non-pharmacological analgesics have been shown to benefit patients overall. Watching videos, biofeedback, mental imagery, and hypnosis have all been reported to have analgesic effects in the literature. Additionally cognitive behavioral strategies particularly distraction have been shown to reduce pain reports as high as 85% of patients. The most recent emerging technique is virtual reality.

Virtual reality creates the illusion that user is immersed in another environment. A three dimensional world is seen through the eyepieces, and the user can interact with the world in several ways: by moving their head and neck to look around the environment and a hand held trigger allows you to shoot at objects within the environment. Because this is a more interactive environment and more attention capturing than simple distractions, VR is thought to be more beneficial than basic distraction techniques. Additionally, using a head-mounted display (HMD) prevents visual perception of the real world, decreasing the chance of distraction. Previous uses of distraction show that children only pay attention to the distraction for 2/3 of the procedure, but virtual reality prevents the distraction of the procedure's visual stimuli.

In this study the investigators will attempt to determine the benefit of using virtual reality distraction techniques with a head-mounted display in standard orthopedic consultations that involve pain. The literature review indicates that excepting burns, this study has not been performed previously. Additionally heart rate monitoring has not been previously been included in the analysis of pain reduction. The investigators will assess pain reduction using patient feedback and pain scales, but also heart rate monitoring pre-procedure, during procedure, and post-procedure. In this study, the only procedure will be cast removal.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presented for an in-office procedure after a primary orthopedic injury
  • •Willing to participate in the study.
  • •Between age of 5 and 18

排除标准

  • •Any condition limiting subject ability to perceive and communicate information including developmental delay, Cerebral Palsy, or Autism Spectrum Disorder.
  • •Limitations in subject ability to use the VR system including an inability to sit upright or bilateral upper extremity injuries

研究组 & 干预措施

Virtual Reality Intervention Group

Experimental

Patient is fitted with a Virtual Reality headset and handheld remote control. Subject is able to play an interactive game during the duration of the in-office procedure.

干预措施: Virtual Reality Headset and handheld remote control. (Behavioral)

Control Group

No Intervention

standard of care

结局指标

主要结局

Change in Heart Rate

时间窗: Baseline HR measured 2 minutes pre-operation. Procedural HR measured during procedure.

Change from baseline max HR to intra-procedural max HR

次要结局

  • Perceived Anxiety(measured within 5 minutes of procedure completion)
  • Perceived Pain(measured within 5 minutes of procedure completion)

研究者

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

Lawrence Haber

Principal Investigator

Ochsner Health System

研究点 (1)

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