Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: t
View:

• Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital

• Aged 21 to 65

• Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital

• Aged 21 to 65

Locations
United States
New York
NYU Langone Brooklyn
RECRUITING
Brooklyn
Contact Information
Primary
Maysaa El Zoghbi, MD
Maysaa.ElZoghbi@nyulangone.org
216-835-7626
Backup
Jessica Rauch
Jessica.rauch@nyulangone.org
332-268-0626
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2026-04
Participants
Target number of participants: 20
Treatments
Experimental: 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 recovery area
No_intervention: Endoscopic Procedure only
The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov