Recruiting

Virtual Reality

Sponsor:

NYU Langone Health

Code:

NCT06349564

Conditions

Sedative During Endoscopy

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Pico 4 Enterprise headset with noise cancelling headphones

Study Details

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.

Conditions

Sedative During Endoscopy

Study ID

NCT06349564

Start date

Dec 9, 2024

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

INTERVENTION GROUP

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

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Pico 4 Enterprise headset with noise cancelling headphones

The device includes a computer tablet and virtual reality headset.

Primary outcome measure

  • Total amount of sedative drugs administered during the procedure [ Time Frame: End of procedure, up to 1 hour ]

Central Contacts and Locations

Central contacts

Maysaa El Zoghbi, MD

216-835-7626Maysaa.ElZoghbi@nyulangone.org

Gregory Faulx

216-213-7413gregory.faulx@nyulangone.org

Locations

NYU Langone Brooklyn

Recruiting

Brooklyn, New York, United States, 11220

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • GERD
  • Dyspepsia
  • screening colonoscopy
  • diagnostic upper endoscopy
  • Gastroesophageal reflux disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-19.