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临床试验/NCT04349150
NCT04349150已完成不适用

A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年5月10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
31
试验地点
1
主要终点
Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue

研究概览

简要总结

Colonoscopy patients will be fitted with a virtual reality head-mounted display, and virtual experiences will be initiated prior to colonoscope insertion. Colonoscopy will be initiated without standard sedatives and narcotics. The colonoscopy will proceed with the subject using virtual reality distraction instead of pharmacological sedation for as long as s/he would like. Standard sedatives and narcotics will be administered upon participant request at any time during the procedure. Questionnaires will be administered to the subject and the endoscopist after each procedure to assess the acceptability of use of virtual reality in the colonoscopy setting.

详细描述

This study aims to assess whether virtual reality is an acceptable alternative to pharmacological sedation during colonoscopy. Past research has shown that in order to fully experience pain, one must pay attention to it. Virtual reality has been shown to help mitigate pain by providing distraction from the painful stimulus.

In this study, participants undergo screening or surveillance colonoscopy under virtual reality distraction.

Individuals who are scheduled for a routine screening or surveillance colonoscopy and have had at least one prior colonoscopy under conscious sedation are eligible to participate. Those who give written, informed consent are fitted with and oriented to a virtual reality head-mounted display. The subject is then prepped for the colonoscopy by a registered nurse per institution protocol. This includes placement of an intravenous line.

Written consent is obtained for colonoscopy with medication by the performing endoscopist. The patient is again fitted with the virtual reality head-mounted display and virtual experiences are initiated. The endoscopist performs the colonoscopy with the subject using virtual reality distraction instead of pharmacological sedation for as long as the subject likes. Standard sedatives and narcotics will be administered by a registered nurse upon participant request at any time during the procedure.

Following the procedure, participants and endoscopists complete a questionnaire about their subjective experience with virtual reality during colonoscopy. The research coordinator fills out a case report form for each subject with information about the procedure including length, colonoscopy findings, and complications as noted by the endoscopist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
是

入选标准

  • •Adult (18 years or older)
  • •Scheduled for screening or surveillance colonoscopy
  • •Has undergone at least 1 prior colonoscopy under conscious sedation

排除标准

  • •Children (<18 years)
  • •Scheduled to undergo colonoscopy under general anesthesia
  • •Scheduled to undergo colonoscopy with no sedation
  • •First-time colonoscopy patients
  • •Scheduled for colonoscopy to assess symptoms or pre-existing disease

研究组 & 干预措施

Virtual reality

Experimental

Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics

干预措施: Virtual reality (Device)

结局指标

主要结局

Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue

时间窗: This data will be collected within 60 minutes of completion of the colonoscopy

Measured as (x/n) \* 100, where x = number of participants who completed colonoscopy using virtual reality and no pharmacological rescue, and n = total number of participants who initiated colonoscopy using virtual reality.

Number of Participants With Cecal Intubation

时间窗: This data will be collected within 60 minutes of completion of the colonoscopy

Number of Participants with Cecal Intubation using virtual reality and no pharmacological sedation. Measured as x/n, where x = number of participants in whom cecal intubation is achieved when participant is using virtual reality and no pharmacological sedation, and n = total number of participants who initiated colonoscopy using virtual reality.

次要结局

  • Participant Satisfaction(This data will be collected within 60 minutes of completion of the colonoscopy)
  • Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation(This data will be collected within 60 minutes of completion of the colonoscopy)
  • Endoscopist Satisfaction(This data will be collected within 60 minutes of completion of the colonoscopy)
  • Participant-reported Pain and Discomfort Levels(This data will be collected within 60 minutes of completion of the colonoscopy)
  • Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice(This data will be collected within 60 minutes of completion of the colonoscopy)

研究者

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

Daniel C Chung

Daniel C Chung, MD, Director of High-Risk GI Cancer Clinic

Massachusetts General Hospital

研究点 (1)

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