Implementing Virtual Reality (VR) to Reduce Sedation

NYU Langone Health

Status: Enrolling

Conditions: Sedative During Endoscopy

Treatments: Device: Pico 4 Enterprise headset with noise cancelling headphones

Study type: Interventional

Funder types: Other

Identifiers

NCT06349564

23-01443

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Endoscopic Procedure with VR Headset

Experimental group

Description:

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

Treatment:

Device: Pico 4 Enterprise headset with noise cancelling headphones

Endoscopic Procedure only

No Intervention group

Description:

The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.