Actively Recruiting
Impact of Virtual Reality in Cardiac Electrophysiology
Led by University of Calabria · Updated on 2025-08-07
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Virtual Reality in Cardiac Electrophysiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥ 18 years
- Candidates for pacemaker or implantable cardioverter-defibrillator implantation, including leadless pacemakers and subcutaneous ICDs
- Ability to provide written informed consent
- Ability to understand how to use the VR headset and report pain using the numeric rating scale
You will not qualify if you...
- Severe cognitive, psychiatric, or neurological disorders that impair understanding or cooperation
- Visual, auditory, or inner ear disorders or severe vertigo that could worsen with VR use
- Allergies or adverse reactions to standard sedative medications like midazolam
- Inability to properly wear the VR headset due to facial deformities or recent craniofacial trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Annunziata" Hospital
Cosenza, Italy, 87100
Actively Recruiting
Research Team
A
Antonio Curcio, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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