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临床试验/NCT05701566
NCT05701566招募中不适用

Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.

研究概览

简要总结

A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

详细描述

VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • adult patients (≥18) with any elective indication for colonoscopy.

排除标准

  • known seizures' disorders, cognitive, visual or auditory impairment.
  • patients who were unable or unwilling to sign an informed consent.
  • Pregnant women.

结局指标

主要结局

Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.

时间窗: 1 day

Questionnaire (1 - not satisfied at all, 5 - very satisfied)

次要结局

  • Pain during the procedure(1 day)
  • polyp detection rate (PDR)(during colonoscopy procedure)
  • Colonoscopy duration(during colonoscopy procedure)
  • Post colonoscopy adverse events(1 day)
  • Time-to-return to daily activities (work, driving)(1 day)
  • Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)(1 day)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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