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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
In this group, virtual reality will be added to usual care
Istituto CardioCentro
Lugano, Canton Ticino, Switzerland
RECRUITINGGlobal pain intensity experienced during the procedure.
Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Time frame: At the end of surgery
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.
Time frame: At the end of surgery
Global anxiety intensity experienced during the procedure.
Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: At the end of surgery
Maximal systolic arterial blood pressure.
Maximal systolic arterial blood pressure recorded during the procedure.
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Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: At the end of surgery
Intra- and post-procedure complications.
Registration of any complication during and after the procedure.
Time frame: 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).
Time frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)