Implementing Virtual Reality (VR) to Reduce Sedation

Not Applicable

Recruiting

• Conditions: Sedative During Endoscopy
• Interventions: Device: Pico 4 Enterprise headset with noise cancelling headphones

• Registration Number: NCT06349564
• Lead Sponsor: NYU Langone Health

Brief Summary

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 decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-05
• Study Start: 2024-12-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Undergoing 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Procedure with VR Headset	Pico 4 Enterprise headset with noise cancelling headphones	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 recovery area

Primary Outcome Measures

Name	Time	Method
Total amount of sedative drugs administered during the procedure	End of procedure, up to 1 hour

Secondary Outcome Measures

Name	Time	Method
Patient-reported discomfort or pain (using 0-10 pain scale)	During PACU stay, approximately 30 minutes
Overall patient satisfaction scores	During PACU stay, approximately 30 minutes	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.
PACU length of stay	End of PACU stay, approximately 30 minutes
Number of events of complications from VR	During PACU stay, approximately 30 minutes	Events such as nausea, vomiting, dizziness.
Number of technical failures	End of procedure, up to 1 hour
Troubleshooting time	End of procedure, up to 1 hour
Duration of the procedure	End of procedure, up to 1 hour

Trial Locations

Locations (1)

NYU Langone Brooklyn; 🇺🇸 Brooklyn, New York, United States