NCT07009951

Impact of Virtual Reality in Cardiac Electrophysiology

Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Calabria · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Acute

Interventions

Type	Name	Description
DEVICE	Virtual reality	VR headset provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort).

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-06-08
• Last updated: 2025-08-07

Locations

1 site across 1 country: Italy