An interventional study of Pico 4 Enterprise headset with noise cancelling headphones in Sedative During Endoscopy, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 10 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
INTERVENTION GROUP
Inclusion Criteria:
Exclusion Criteria:
CONTROL GROUP
Inclusion Criteria:
Exclusion Criteria:
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 control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023.
The device includes a computer tablet and virtual reality headset.
Total amount of sedative drugs administered during the procedure
Time frame: End of procedure, up to 1 hour
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
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.
Time frame: During PACU stay, approximately 30 minutes
Number of events of complications from VR
Events such as nausea, vomiting, dizziness.
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
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
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.
No publications or documents are linked to this record.
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