Impact of Virtual Reality in Cardiac Electrophysiology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality.
- Who it may be relevant to
- Registry conditions: Pain, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
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.
Interventions
- Device Virtual reality
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).
Primary outcome measures
- Pain and discomfort [Time frame: during electrophysiology procedures]
- Systolic Blood Pressure [Time frame: during electrophysiology procedures]
- Heart Rate [Time frame: during electrophysiology procedures]
- Respiratory Rate [Time frame: during electrophysiology procedures]
- Oxygen Saturation [Time frame: during electrophysiology procedures]
Secondary outcome measures (2)
- Patient satisfaction [Time frame: during electrophysiology procedures]
- Hospital stay length [Time frame: through study completion, an average of 7 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- "Annunziata" Hospital — Cosenza
Identifiers
NCT: NCT07009951 · 60/2025