NCT05701566

Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

Detailed description

VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.

Conditions

• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	virtual reality headset	use of virtual reality headset during colonoscopy as a substitute to sedation.
OTHER	colonoscopy with standard sedation.	use of standard sedation during colonoscopy.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-02-01
• Completion: 2023-12-01
• First posted: 2023-01-27
• Last updated: 2023-04-10

Locations

1 site across 1 country: Israel