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临床试验/NCT04759183
NCT04759183已完成不适用

Impact of Different Virtual Reality Experiences on Anxiety and Pain

OHSU Knight Cancer Institute2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change in postoperative pain scores

研究概览

简要总结

This trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.

详细描述

PRIMARY OBJECTIVE:

I. To measure the impact of a gaming virtual reality (VR) experience compared to a mindfulness VR experience on preoperative anxiety and postoperative pain.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.

ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 years or older and younger than 89)
  • Able to consent
  • English-speaking

排除标准

  • Non-English speaking patients because the VR content is only available in English
  • Have symptoms concerning for an active respiratory infection or are on contact or isolation precautions
  • Any active eye discharge
  • A history of seizure, epilepsy, or hypersensitivity to flashing light
  • Have a history of motion sickness or vertigo
  • Have active nausea or vomiting
  • Psychiatric conditions that may interfere with the ability to successfully participate in the study
  • Have cardiac pacemakers
  • Require hearing aids at all times that cannot be removed
  • Have defibrillators
  • Have wound dressings on the head or neck that prevent comfortable use of the VR headset

结局指标

主要结局

Change in postoperative pain scores

时间窗: Baseline after surgery up to study completion (estimated 1 day)

Assessed by VAS scale from 0-100mm.

Change in preoperative anxiety scores

时间窗: Baseline up to pre surgery (estimated 1 day)

Assessed by visual analogue scale (VAS) from 0-100mm.

次要结局

  • Change in blood pressure(immediately before intervention, and then immediately after intervention (estimated 1 day))
  • Patient enjoyment of each VR experience(Up to study completion (estimated 1 day))
  • Change in heart rate(immediately before intervention, and then immediately after intervention (estimated 1 day))
  • Patient desire to use VR more in their healthcare(Up to study completion (estimated 1 day))

研究者

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

Ryan Li, MD

Principal Investigator

OHSU Knight Cancer Institute

研究点 (2)

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