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The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | In this group, virtual reality will be added to usual care |
|
| Standard Group | No Intervention | In this group, no extra intervention will be added to usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality application | Device | In this group, virtual reality will be added to usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global pain intensity experienced during the procedure. | Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). | At the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Need for supplementary sedation and/or analgesia during the procedure. | The need for supplementary sedation and/or analgesia during the procedure will be recorded. The doses of the drugs will be recorded. | At the end of surgery |
| Global anxiety intensity experienced during the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herve Schlotterbeck, MD | Contact | +41918115189 | herve.schlotterbeck@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto CardioCentro | Recruiting | Lugano | Canton Ticino | 6900 | Switzerland |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). |
| At the end of surgery |
| Patient's comfort during the procedure assessed by the surgeon and cardiologist. | Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS). | At the end of surgery |
| Incidence of motion sickness during the virtual reality experience. | Incidence of motion sickness during the virtual reality experience (for example nausea) | At patient discharge (or at a maximum of 4 hours after the end of surgery) |
| Patient's perceived procedure duration. | Patient's perceived procedure duration compared to effective procedure duration. | At the end of surgery |
| Maximal systolic arterial blood pressure. | Maximal systolic arterial blood pressure recorded during the procedure. | At the end of surgery |
| Incidence of hypotensive or hypoxic events during procedure. | Incidence of hypotensive events (defined by systolic arterial blood pressure less than 90 mmhg) and/or hypoxic events (defined by oxygen saturation under 90%) during the procedure. | At the end of surgery |
| Total dose of local anaesthetic used during the procedure. | Total dose of local anaesthetic used during the procedure (total dose in mg). | At the end of surgery |
| Change in anesthetic strategy during procedure. | If a change of anesthesiologic strategy is needed during the procedure (for example, if the patient needs an unplanned general anesthesia during the procedure). | At the end of surgery |
| Interruption of virtual reality experience during the procedure. | If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure. | At the end of surgery |
| Intra- and post-procedure complications. | Registration of any complication during and after the procedure. | At patient discharge (or at a maximum of 4 hours after the end of surgery) |
| Overall patient's comfort and satisfaction experienced during the procedure. | Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points). | At patient discharge (or at a maximum of 4 hours after the end of surgery) |