Impact of Virtual Reality in Cardiac Electrophysiology

University of Calabria100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Pain, Acute

Interventions

Virtual realityDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Outcomes

Primary Outcomes

Pain and discomfort

To evaluate the difference in pain perception between a group using virtual reality (VR) and a control group subjected only to standard sedation, measured using the Numeric Rating Scale (NRS). The NRS is a self-reported scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain and discomfort. The NRS will be recorded at the end of the procedure, referring to the pain experienced during the entire electrophysiology procedure.