임상 레이더 AI | ||
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임상시험 NCT06349564은(는) Sedative During Endoscopy에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Implementing Virtual Reality (VR) to Reduce Sedation 10 비대면
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06349564은(는) Sedative During Endoscopy에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2024년 12월 9일에 시작되어 10명의 참여자를 모집하고 있습니다. NYU Langone Health이(가) 진행하며, 2026년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 19일에 갱신되었습니다.
간단한 개요
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...더 보기
공식 제목
Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
질환명
Sedative During Endoscopy기타 연구 식별자
- 23-01443
NCT 번호
실제 연구 시작일
2024-12-09
최신 업데이트 게시
2026-03-19
예상 연구 완료일
2026-09
계획된 등록 인원
10
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
GERD
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
주요 목적
지지요법
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Endoscopic 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...더 보기 | Pico 4 Enterprise headset with noise cancelling headphones The device includes a computer tablet and virtual reality headset. |
비개입Endoscopic Procedure only The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Total amount of sedative drugs administered during the procedure | End of procedure, up to 1 hour |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
21 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- 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 Health연구 대표 연락처
연락처: Maysaa El Zoghbi, MD, 216-835-7626, [email protected]
연락처: Gregory Faulx, 216-213-7413, [email protected]
1 1개국에 임상시험 장소
New York
NYU Langone Brooklyn, Brooklyn, New York, 11220, United States
모집중