Virtual reality to reduce discomfort during pacemaker and defibrillator implantation

Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory

We will test whether using virtual reality during pacemaker or implantable defibrillator implantation helps lower pain and anxiety for adult patients compared with standard sedation alone.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Calabria (Academic / other)
• Locations: 1 site (Cosenza)
• Trial ID: NCT07009951 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, randomized study at Annunziata Hospital that assigns adults undergoing pacemaker or ICD implantation to either standard sedation alone or standard sedation plus a VR headset for distraction. Pain will be measured with a numeric rating scale and vital signs will be monitored throughout the procedure, while patient satisfaction and adverse events are recorded. The trial includes modern device types such as leadless pacemakers and subcutaneous ICDs and also explores whether VR can support same-day discharge after minimally invasive procedures. Outcomes will compare pain levels, sedation needs, physiological stability, and safety between the two groups.

Who should consider this trial

Good fit: Adult patients (≥18 years) scheduled for pacemaker or implantable cardioverter-defibrillator implantation who can provide informed consent and use a VR headset are ideal candidates.

Not a fit: Patients with severe cognitive, psychiatric, visual, auditory, or vestibular disorders or those who cannot correctly position a VR headset are unlikely to benefit from the VR intervention.

Why it matters

Potential benefit: If successful, adding VR could reduce procedural pain and anxiety, reduce sedation needs, and improve recovery and readiness for same-day discharge.

How similar studies have performed: Previous randomized and nonrandomized studies in other procedural settings have shown that VR can reduce pain and anxiety, but applying VR specifically to pacemaker or ICD implantation is relatively novel.

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).

Where this trial is running

Cosenza

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

Study contacts

• Study coordinator: Antonio Curcio, Prof.

Conditions Pain, Acute