Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT05701566
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: