Impact of Virtual Reality in Cardiac Electrophysiology

University of Calabria

Status: Enrolling

Conditions: Pain, Acute

Treatments: Device: Virtual reality

Study type: Observational

Funder types: Other

Identifiers

NCT07009951

60/2025

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

100 participants in 2 patient groups

Virtual reality Group

Description:

Patients who receive a virtual reality headset that 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).

Treatment:

Device: Virtual reality

Control Group (Standard Sedation)

Description:

Patients who receive standard sedation (e.g. midazolam and/or fentanyl at the operator's discretion, according to hospital protocol), in accordance with comfort and analgesia guidelines for cardiac pacing procedures.