Implementing Virtual Reality (VR) to Reduce Sedation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pico 4 Enterprise headset with noise cancelling headphones.
- Who it may be relevant to
- Registry conditions: Sedative During Endoscopy. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy
Overview
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.
Interventions
- Device Pico 4 Enterprise headset with noise cancelling headphones
The device includes a computer tablet and virtual reality headset.
Primary outcome measures
- Total amount of sedative drugs administered during the procedure [Time frame: End of procedure, up to 1 hour]
Secondary outcome measures (7)
- Patient-reported discomfort or pain (using 0-10 pain scale) [Time frame: During PACU stay, approximately 30 minutes]
- Duration of the procedure [Time frame: End of procedure, up to 1 hour]
- Overall patient satisfaction scores [Time frame: During PACU stay, approximately 30 minutes]
- Number of events of complications from VR [Time frame: During PACU stay, approximately 30 minutes]
- Number of technical failures [Time frame: End of procedure, up to 1 hour]
- Troubleshooting time [Time frame: End of procedure, up to 1 hour]
- PACU length of stay [Time frame: End of PACU stay, approximately 30 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Brooklyn — Brooklyn
Identifiers
NCT: NCT06349564 · 23-01443