Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT07009951
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Virtual Reality in Cardiac Electrophysiology
Sponsor:
University of Calabria
Organization:
Study Overview
Official Title:
Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
Status:
RECRUITING
Status Verified Date:
2025-08
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:
Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: