Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279481
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-12-22
Brief Title:
Effect of Virtual Reality VR on Pain Relieve During Colonoscopy
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Effect of Virtual Reality VR on Pain Relieve During Colonoscopy A Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
Purpose To evaluate the effectiveness and safety of virtual reality VR technology in alleviating pain during colonoscopy
Design and Methods In the context of a single-centered prospective randomized controlled study the pain levels experienced during colonoscopy are compared between the VR group and the control group
Design and Methods In the context of a single-centered prospective randomized controlled study the pain levels experienced during colonoscopy are compared between the VR group and the control group
Detailed Description:
Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices The primary outcome measure will be the assessment of pain levels during colonoscopy which will be quantified using the Visual Analogue Scale Additionally researchers will assess anxiety levels using the State-Trait Anxiety Inventory both before and after the colonoscopy procedure Vital signs during colonoscopy procedural effects and adverse effects would also be analyzed
Study Oversight
Has Oversight DMC:
None
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?:
None