Impact of Virtual Reality in Cardiac Electrophysiology

Recruiting

• Conditions: Pain, Acute

• Registration Number: NCT07009951
• Lead Sponsor: University of Calabria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-06-03
• Study First Posted: 2025-06-08
• Study Start: 2025-07-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and discomfort	during electrophysiology procedures	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.
Oxygen Saturation	during electrophysiology procedures	To compare the change in oxygen saturation (SpO₂, %) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Systolic Blood Pressure	during electrophysiology procedures	To compare the change in systolic blood pressure (mmHg) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Heart Rate	during electrophysiology procedures	To compare the change in heart rate (beats per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Respiratory Rate	during electrophysiology procedures	To compare the change in respiratory rate (breaths per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	during electrophysiology procedures	To evaluate patient satisfaction with the overall experience of the procedure. Satisfaction will be assessed using a structured questionnaire at the end of the procedure. Results will be expressed as a percentage score from 0% to 100%, where higher percentages indicate greater satisfaction. The satisfaction level will be categorized as follows: 0-20%: Very unsatisfied 21-40%: Unsatisfied 41-60%: Neither satisfied nor unsatisfied 61-79%: Satisfied 80-100%: Very satisfied
Hospital stay length	through study completion, an average of 7 days	To evaluate whether the use of virtual reality (VR) during electrophysiology procedures can contribute to a reduction in hospital stay, potentially allowing early discharge in some cases. The outcome will be measured as the mean number of days of hospital stay, and the difference between the VR group and the control group will be assessed.

Trial Locations

Locations (1)

"Annunziata" Hospital; 🇮🇹 Cosenza, Italy