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This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | The study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention | Up to the initiation of pre-oxygenation (same day) |
| Measure | Description | Time Frame |
|---|---|---|
| Richmond Agitation Sedation Score (RAAS) | The Richmond Agitation-Sedation Scale (RASS) will be used to assess the level of agitation and sedation in study participants. RASS is a validated 10-point scale ranging from -5 (unarousable) to +4 (combative), with 0 representing alert and calm. Negative scores indicate increasing levels of sedation, while positive scores indicate increasing agitation. | Prior to initiation of pre-oxygenation (intraoperative period, same day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hervé Schlotterbeck, Medical Doctor | Contact | 0041 91 811 51 89 | 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 |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Evaluation of Pa02 and PaC02 in theater | In the operative room, Pa02 and PaC02 (both in mmHg) will be extracted from the first arterial blood gas after insertion of arterial line while the patient is not under oxygen | Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day) |
| External evaluation of patient's comfort | External evaluation by the anesthetist team of preceived patient's comfort in theater with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived comfort | At end of induction, after airway securement (same day) |
| Post-operative qualitative survey | At least 4 hours after the end of anesthesia and patient's extubation, a qualitative survey will be conducted on patient's experience in the preoperative period | From 4 hours after patient's extubation up to 72 hours after patient's extubation |
| Compliance with the VR intervention | Proportion of patients who required the interruption of the VR intervention | From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes) |
| Post-operative evaluation of patient's satisfaction regarding pre-operative period | Evaluation of patient's satisfaction regarding the pre-operative period with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived level of satisfaction | From 4 hours after patient's extubation up to 72 hours after patient's extubation |
| Incidence of cyberslckness | Symptoms of cybersickness such as disorientation, dizziness, eye problems (fatigue, blurred vision, headache) will be monitored | From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention |
| Incidence of secondary effects linked to the use of anxiolytic premedication | For patients requesting a premedication, secondary effects like cognitive impairment, sedation, respiratory depressions will be registered | From administration of anxiolytic medication until initiation of pre-oxygenation (same day) |
| Time to Administration of Anxiolytic Premedication | After the study intervention, patient will be asked if he still wants to assume anxiolytic premedication. In case of positive answer, anxiolytic premedication will be given and time will be noted. In case of negative answer, no anxiolytic premedication will be given. In the following moments, in case of change in patient's anxiety level with a secondary request of anxiolytic premedication, "rescue" premedication will be given and timing will be noted. | Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable. |
| Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA) | Change in Visual Analogue Scale for anxiety (VASA) between 3 time points. VASA scale ranges from 0 to10 with 10 corresponding to the highest level of anxiety. | From immediately before VR session to operating room entry (same day) |
| Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS) | Change in APAIS scale between 3 time points. 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. | From immediately before VR session to operating room entry (same day) |
| Change in blood pressure over time | Variation of blood pressure (systolic arterial pressure, diastolic arterial pressure, mean arterial pressure) between 3 time points. | From immediately before VR session to operating room entry (same day) |
| Change in oxygen saturation over time | Variation of oxygen saturation measured with finger pulsoxymeter between three time points. | From immediately before VR session to operating room entry (same day) |
| Change in heart rate over time | Variation of heart rate measured between three time points. | From immediately before VR session to operating room entry (same day) |