Implementing Virtual Reality (VR) to Reduce Sedation

April 4, 2024 updated by: NYU Langone Health

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11220
        • NYU Langone Brooklyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Pico 4 Enterprise headset with noise cancelling headphones
The device includes a computer tablet and virtual reality headset.
No Intervention: Endoscopic Procedure only
The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total amount of sedative drugs administered during the procedure
Time Frame: End of procedure, up to 1 hour
End of procedure, up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported discomfort or pain (using 0-10 pain scale)
Time Frame: During PACU stay, approximately 30 minutes
During PACU stay, approximately 30 minutes
Duration of the procedure
Time Frame: End of procedure, up to 1 hour
End of procedure, up to 1 hour
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.
During PACU stay, approximately 30 minutes
Number of events of complications from VR
Time Frame: During PACU stay, approximately 30 minutes
Events such as nausea, vomiting, dizziness.
During PACU stay, approximately 30 minutes
Number of technical failures
Time Frame: End of procedure, up to 1 hour
End of procedure, up to 1 hour
Troubleshooting time
Time Frame: End of procedure, up to 1 hour
End of procedure, up to 1 hour
PACU length of stay
Time Frame: End of PACU stay, approximately 30 minutes
End of PACU stay, approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Maysaa El Zoghbi, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23-01443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Maysaa.ElZoghbi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Maysaa.ElZoghbi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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