Impact of Virtual Reality in Cardiac Electrophysiology

Recruiting now

Conditions studied: Pain, Acute

In brief

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.

Key facts

Study ID

NCT07009951

Run by

University of Calabria

People needed

100

Starts

2025-07-01

Expected to finish

2025-12-31

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
• Ability to provide written informed consent.
• Ability to understand the use of the VR headset and express a pain score using the NRS scale.

You may not qualify if…

• Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
• Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
• Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
• Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).

Where it is running

• "Annunziata" Hospital — Cosenza, Italy (enrolling)

Full record on ClinicalTrials.gov

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