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The goal of this clinical trial is to learn if the use of virtual reality immersion during pre-oxygenation before general anesthesia could be feasible and beneficial for the patient. The main questions it aims to answer are:
Does virtual reality immersion during pre-oxygenation reduce patient's anxiety? Does it impact patient's and anaesthetist's comfort? Is this technique easy to implement?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality immersion | Device | The study intervention, defined by the use of a virtual reality, exclusively takes place during the pre-oxygenation period where the patient is exposed to a virtual reality immersion scenario. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Anxiety during pre-oxygenation | Anxiety will be assessed with the Visual Analogue Scale for Anxiety (VASA) scale ranging from 0 to 10 (0 corresponds to the lowest level of anxiety and 10 to maximal level of anxiety). | 4 min after the beginning of pre-oxygenation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient's anxiety over time | Change in Visual Analogue Scale for anxiety (VASA) between 4 time points. VASA scale ranges from 0 to 10 with 10 corresponding to the highest level of anxiety. | The four time points are: in the ward on the day of surgery, in the theater once the patient is monitored and before pre-oxygenation, 4 min after the beginning of pre-oxygenation, in the ward at least two hours after the end of surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Cardiocentro | Lugano | Canton Ticino | 6900 | Switzerland |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Success rate in recruiting patients to participate to the study | Rate of patients accepting to participate to the study. The number of patients accepting to participate will be descrided in percent (%) with the denominator beeing the sum of patients who accepted and refused to participate to the study. | During study recruitment. |
| Completed pre-oxygenation with virtual reality headset | Rate of patient who completed pre-oxygenation with the virtual reality headset. The rate of patient who completed the pre-oxygenation with the virtual reality headset will be measured in percent (%). | From the beginning to the end of the pre-oxygenation period. |
| Anxiety evaluation with the Amsterdam Preoperative Anxiety and Information scale (APAIS) score | The APAIS score is a validated score to evaluate anxiety in the preoperative context. It ranges from 6 to 30 with the highest score corresponding to a high level of anxiety. | At two times: on the day of surgery while the patient is still in the ward and after entry in the OR up to the beginning of pre-oxygenation. |
| Change in blood pressure over time | Variation of blood pressure (systolic arterial pressure, diastolic arterial pressure, mean arterial pressure) between four time points. | The four time points are: in the ward on the day of surgery, the first blood pressure measured in theater, at the beginning of the pre-oxygenation and at the end of the pre-oxygenation (just before the beginning of the general anaesthesia induction) |
| Change in oxygen saturation over time | Variation of oxygen saturation measured with finger pulsoxymeter between four time points. | The four time points are: in the ward on the day of surgery, the first oxygen saturation measured in theater, at the beginning of the pre-oxygenation and at the end of the pre-oxygenation (just before the beginning of the general anaesthesia induction) |
| Change in heart rate over time | Variation of heart rate measured between four time points. | The four time points are: in the ward on the day of surgery, the first heart rate measured in theater, at the beginning of the pre-oxygenation and at the end of the pre-oxygenation (just before the beginning of the general anaesthesia induction) |
| Patient's comfort during pre-oxygenation | Patient will be asked it's level of comfort during pre-oxygenation with a Likert scale ranging from 0 to 10 (with 0 corresponding to the maximum comfort and 10 to the minimal comfort). | During pre-oxygenation (at 2 minutes after pre-oxygenation initiation). |
| Incidence of cybersickness | Incidence of cybersickness during the pre-oxygenation period in percent (%). | From the beginning to the end of the pre-oxygenation period. |
| Comfort of the anesthetic team during pre-oxygenation | Evaluation of the involved anesthetic team comfort regarding the pre-oxygenation technique with a Likert scale ranging from 1 to 5 (1 corresponding to the lowest level of comfort and 5 to the highest level of comfort). | From the beginning to the end of the pre-oxygenation period. |
| Perceived comfort of the patient during pre-oxygenation | Perceived comfort of the patient during pre-oxygenation by the involved anesthetist team with a Likert scale ranging from 1 to 5 (1 beeing the lowest level of comfort and 5 beeing the highest level of comfort). | From the beginning to the end of the pre-oxygenation period. |
| Wake up quality test | Wake up quality test with a 3-point scale (good, satisfactory, poor). | From the beginning of the awakening after general anesthesia to the removal of the airway device. |
| Patient's satisfaction regarding the pre-oxygenation period | Evaluation of patient's satisfaction regarding the pre-oxygenation technique with a 5-point Likert scale (1 beeing the lowest level of satisfaction and 5 the highest level of satisfaction) | From 2 hours after the end of anesthesia to the first day after surgery. |
| Qualitative post-operative survey regarding patient's experience during pre-oxygenation | Qualitative post-operative survey with questions about patient's experience during pre-oxygenation. | From 2 hours after the end of anesthesia to the first day after surgery. |