Implementing Virtual Reality (VR) to Reduce Sedation

Conditions

• Sedative During Endoscopy

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Pico 4 Enterprise headset with noise cancelling headphones — DEVICE
  The device includes a computer tablet and virtual reality headset.

Study Details

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.

Key Dates

Start date

Dec 9, 2024

Status verified

Mar 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• 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
• 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.

Primary Outcome Measure

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

Central Contacts

• Maysaa El Zoghbi, MD
  216-835-7626
  [email protected]
• Gregory Faulx
  216-213-7413
  [email protected]

Locations (1)

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