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El ensayo clínico NCT06349564 para Sedative During Endoscopy está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Implementing Virtual Reality (VR) to Reduce Sedation 10 Virtual
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06349564 es un estudio intervencionista para Sedative During Endoscopy. Su estado actual es: reclutando. El estudio se inició el 9 de diciembre de 2024, con el objetivo de reclutar a 10 participantes. Dirigido por NYU Langone Health, se espera que finalice el 1 de septiembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 19 de marzo de 2026.
Resumen
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...Mostrar más
Título oficial
Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
Condiciones médicas
Sedative During EndoscopyOtros ID del estudio
- 23-01443
Número del NCT
Inicio del estudio (real)
2024-12-09
Última actualización
2026-03-19
Fecha de finalización (estimada)
2026-09
Inscripción (prevista)
10
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
GERD
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
Objetivo principal
Cuidados de apoyo
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalEndoscopic 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...Mostrar más | Pico 4 Enterprise headset with noise cancelling headphones The device includes a computer tablet and virtual reality headset. |
Sin intervenciónEndoscopic Procedure only The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Total amount of sedative drugs administered during the procedure | End of procedure, up to 1 hour |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
21 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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 HealthContactos centrales del estudio
Contacto: Maysaa El Zoghbi, MD, 216-835-7626, [email protected]
Contacto: Gregory Faulx, 216-213-7413, [email protected]
1 Centros del estudio en 1 países
New York
NYU Langone Brooklyn, Brooklyn, New York, 11220, United States
Reclutando