Clinical Trial

Impact of Virtual Reality in Cardiac Electrophysiology

Recruiting
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Record status
This record was last updated August 7, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-03; most recent amendment 2025-08-06.
Status change: Not Yet Recruiting → Recruiting 2025-08-06
Trial Details
NCT Number NCT07009951
Lead Sponsor University of Calabria
Conditions Pain, Acute
Enrollment 100 participants
Start Date 2025-07-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-07