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NCT Number: NCT06349564

Implementing Virtual Reality (VR) to Reduce Sedation

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.

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Key information

Conditions

Sedative During Endoscopy Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Brooklyn

Brooklyn, New York, 11220, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pico 4 Enterprise headset with noise cancelling headphones

Device

The device includes a computer tablet and virtual reality headset.

Primary outcomes

  1. Total amount of sedative drugs administered during the procedure

    Time frame: End of procedure, up to 1 hour

Secondary outcomes

  1. Patient-reported discomfort or pain (using 0-10 pain scale)

    Time frame: During PACU stay, approximately 30 minutes

  2. Duration of the procedure

    Time frame: End of procedure, up to 1 hour

  3. Overall patient satisfaction scores

    Time frame: 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.

  4. Number of events of complications from VR

    Time frame: During PACU stay, approximately 30 minutes

    Events such as nausea, vomiting, dizziness.

  5. Number of technical failures

    Time frame: End of procedure, up to 1 hour

  6. Troubleshooting time

    Time frame: End of procedure, up to 1 hour

  7. PACU length of stay

    Time frame: End of PACU stay, approximately 30 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Faulx

CONTACT

[email protected]

216-213-7413

Maysaa El Zoghbi, MD

CONTACT

[email protected]

216-835-7626

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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