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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Procedure with VR Headset | Experimental | 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 |
|
| Endoscopic Procedure only | No Intervention | The control group will be chart review of patients undergoing similar endoscopic procedure from November 30, 2023 to June 31st, 2023. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pico 4 Enterprise headset with noise cancelling headphones | Device | The device includes a computer tablet and virtual reality headset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of sedative drugs administered during the procedure | End of procedure, up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported discomfort or pain (using 0-10 pain scale) | During PACU stay, approximately 30 minutes | |
| Duration of the procedure | End of procedure, up to 1 hour | |
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INTERVENTION GROUP
Inclusion Criteria:
Exclusion Criteria:
CONTROL GROUP
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maysaa El Zoghbi, MD | Contact | 216-835-7626 | Maysaa.ElZoghbi@nyulangone.org | |
| Gregory Faulx | Contact | 216-213-7413 | gregory.faulx@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Maysaa El Zoghbi, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Brooklyn | Recruiting | Brooklyn | New York | 11220 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 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. |
| During PACU stay, approximately 30 minutes |
| Number of events of complications from VR | Events such as nausea, vomiting, dizziness. | During PACU stay, approximately 30 minutes |
| Number of technical failures | End of procedure, up to 1 hour |
| Troubleshooting time | End of procedure, up to 1 hour |
| PACU length of stay | End of PACU stay, approximately 30 minutes |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |