Impact of Virtual Reality in Cardiac Electrophysiology
ConditionPain, Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calabria
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients aged ≥18 years, eligible for implantation of cardiac pacing devices, able to provide informed consent and report their level of pain.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Virtual reality
DeviceVR 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Virtual reality Group1 intervention
Group B: Control Group (Standard Sedation)0 interventions
Trial outcomes
Primary outcomes
1
Pain and discomfort
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.
Time frame
during electrophysiology procedures2
Systolic Blood Pressure
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.
Time frame
during electrophysiology procedures3
Heart Rate
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.
Time frame
during electrophysiology procedures4
Respiratory Rate
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.
Time frame
during electrophysiology proceduresSecondary outcomes
1
Patient satisfaction
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
Time frame
during electrophysiology procedures2
Hospital stay length
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.
Time frame
through study completion, an average of 7 daysSponsors and contacts
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Source ClinicalTrials.gov