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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality Group | Patients who receive a virtual reality headset that 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). |
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| Control Group (Standard Sedation) | Patients who receive standard sedation (e.g. midazolam and/or fentanyl at the operator's discretion, according to hospital protocol), in accordance with comfort and analgesia guidelines for cardiac pacing procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during electrophysiology procedures |
| 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. | during electrophysiology procedures |
| 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. | during electrophysiology procedures |
| 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. | during electrophysiology procedures |
| Oxygen Saturation | To compare the change in oxygen saturation (SpOâ‚‚, %) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥18 years, eligible for implantation of cardiac pacing devices, able to provide informed consent and report their level of pain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Curcio, Prof. | Contact | +390984681889 | antonio.curcio.cardio@unical.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Annunziata" Hospital | Recruiting | Cosenza | 87100 | Italy |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| during electrophysiology procedures |
| during electrophysiology procedures |
| 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. | through study completion, an average of 7 days |