Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-12-09
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Pico 4 Enterprise headset with noise cancelling headphones
The device includes a computer tablet and virtual reality headset.
Endoscopic Procedure only
The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.
No interventions assigned to this group
Interventions
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Pico 4 Enterprise headset with noise cancelling headphones
The device includes a computer tablet and virtual reality headset.
Eligibility Criteria
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Inclusion Criteria
* Aged 21 to 65
* Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital
* Aged 21 to 65
Exclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Maysaa El Zoghbi, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Brooklyn
Brooklyn, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-01443
Identifier Type: -
Identifier Source: org_study_id
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