NCT07009951 Impact of Virtual Reality in Cardiac Electrophysiology
| NCT ID | NCT07009951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calabria |
| Condition | Pain, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-07-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07009951 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07009951 currently recruiting?
Yes, NCT07009951 is actively recruiting participants. Contact the research team at antonio.curcio.cardio@unical.it for enrollment information.
Where is the NCT07009951 trial being conducted?
This trial is being conducted at Cosenza, Italy.
Who is sponsoring the NCT07009951 clinical trial?
NCT07009951 is sponsored by University of Calabria. The trial plans to enroll 100 participants.