Clinical trial NCT06349564: Implementing Virtual Reality (VR) to Reduce Sedation
Official title: Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedative During Endoscopy
Keywords: GERD
Dyspepsia
screening colonoscopy
diagnostic upper endoscopy
Gastroesophageal reflux disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Total amount of sedative drugs administered during the procedure
timeFrame: End of procedure, up to 1 hour
Secondary outcomes:
measure: Patient-reported discomfort or pain (using 0-10 pain scale)
timeFrame: During PACU stay, approximately 30 minutes
measure: Duration of the procedure
timeFrame: End of procedure, up to 1 hour
measure: Overall patient satisfaction scores
timeFrame: During PACU stay, approximately 30 minutes
measure: Number of events of complications from VR
timeFrame: During PACU stay, approximately 30 minutes
measure: Number of technical failures
timeFrame: End of procedure, up to 1 hour
measure: Troubleshooting time
timeFrame: End of procedure, up to 1 hour
measure: PACU length of stay
timeFrame: End of PACU stay, approximately 30 minutes
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn
state: New York
Study officials:
affiliation: NYU Langone Health
name: Maysaa El Zoghbi, MD
role: PRINCIPAL_INVESTIGATOR
References: