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临床试验 NCT06349564 针对Sedative During Endoscopy目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Implementing Virtual Reality (VR) to Reduce Sedation 10 虚拟
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临床试验NCT06349564是一项针对Sedative During Endoscopy的干预性研究试验，目前试验状态为招募中。试验始于2024年12月9日，计划招募10名患者。该研究由NYU Langone Health主导，预计于2026年9月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月19日。
简要概括
The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decre...显示更多
官方标题
Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
疾病
Sedative During Endoscopy其他研究标识符
- 23-01443
NCT编号
实际开始日期
2024-12-09
最近更新发布
2026-03-19
预计完成日期
2026-09
计划入组人数
10
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
GERD
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
主要目的
支持治疗
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Endoscopic Procedure with VR Headset VR google with noise cancellation headphones will be placed on patients' heads after a time-out. Patients can select from a range of entertainment videos prior and during the procedure. The anesthesiologist will administer minimal sedation. The patient can request additional sedation if needed. VR immersion continues until the procedure concludes and patients are moved to the recovery area. Goggles are removed in the...显示更多 | Pico 4 Enterprise headset with noise cancelling headphones The device includes a computer tablet and virtual reality headset. |
无干预Endoscopic Procedure only The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Total amount of sedative drugs administered during the procedure | End of procedure, up to 1 hour |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Patient-reported discomfort or pain (using 0-10 pain scale) | During PACU stay, approximately 30 minutes | |
Duration of the procedure | End of procedure, up to 1 hour | |
Overall patient satisfaction scores | Using Likert scale of 1-7. Subjects will be asked to rank several variables on the Likert scale, including overall experience (from 1-very dissatisfied to 7-very satisfied), enjoyability (from 1- not enjoyable to 7-very enjoyable), and anxiety (from 1-extreme anxiety to 7-no anxiety). Scores range from 3-21, higher scores indicate satisfaction. | During PACU stay, approximately 30 minutes |
Number of events of complications from VR | Events such as nausea, vomiting, dizziness. | During PACU stay, approximately 30 minutes |
Number of technical failures | End of procedure, up to 1 hour | |
Troubleshooting time | End of procedure, up to 1 hour | |
PACU length of stay | End of PACU stay, approximately 30 minutes |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
21 Years
适龄性别
全部
接受健康志愿者
是
- Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
- Visual impairments such as blindness which would impair them from watching the entertainment videos.
- Patients with history of CAD,
- History of seizures,
- History of vertigo,
- History of allergy to plastic,
- ASAII or III,
- Patient with active GI bleed, having either melena or hematochezia.
CONTROL GROUP
Inclusion Criteria:
- Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
- Aged 21 to 65
Exclusion Criteria:
- Visual impairments such as blindness which would impair them from watching the entertainment videos
- Patients with history of CAD
- History of seizures
- History of vertigo
- History of allergy to plastic
- ASAII or III
- Patient with active GI bleed, having either melena or hematochezia
NYU Langone Health研究中心联系人
联系人: Maysaa El Zoghbi, MD, 216-835-7626, [email protected]
联系人: Gregory Faulx, 216-213-7413, [email protected]
1 位于 1 个国家/地区的研究中心
New York
NYU Langone Brooklyn, Brooklyn, New York, 11220, United States
招募中