Anxiety, Pre-oxygenation, Virtual Reality
Conditions
Brief summary
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?
Interventions
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.
Sponsors
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All non-ambulatory patients undergoing elective surgery or procedure under general anaesthesia with intravenous induction * Minimal age of 18 year old * Able to give informed consent for the study as documented by signature
Exclusion criteria
* Lacking capacity or ability to complete the consent form and/or questionnaire and interview method and/or incapacity to respond to the required obligations linked to the study protocol (assessed by the operator) * Known cognitive dysfunction, previous history of neurological/psychiatric disease like epilepsy * Depression or anxiety under treatment * Non-Italian speaking patients * Anticipated difficult airway management * Injuries to the head/face that would prohibit wearing headsets * Active nasal bleeding or occlusion, nasal abnormality or recent nasal trauma, recent nasal surgery, significant raised intracranial pressure and base of skull fractures * Any pre-operative premedication, including pharmacological premedication * Rapid sequence induction * Haemodynamic instability * Infectious skin conditions on the head/face * Undrained pneumothorax * Contact isolation due to bacteria and viruses * Symptoms of vertigo or motion sickness * Reduced visual or auditory acuity * BMI \> 35 kg/m2 * Pregnancy * Claustrophobia * Pre-existing hypoxemia (baseline oxygen saturation \< 92% when breathing room air) * Need for an arterial line before general anaesthesia induction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Anxiety during pre-oxygenation | 4 min after the beginning of 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in recruiting patients to participate to the study | During study recruitment. | 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. |
| Completed pre-oxygenation with virtual reality headset | From the beginning to the end of the pre-oxygenation period. | 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 (%). |
| Anxiety evaluation with the Amsterdam Preoperative Anxiety and Information scale (APAIS) score | 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. | 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. |
| Change in blood pressure over time | 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) | Variation of blood pressure (systolic arterial pressure, diastolic arterial pressure, mean arterial pressure) between four time points. |
| Change in oxygen saturation over time | 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) | Variation of oxygen saturation measured with finger pulsoxymeter between four time points. |
| Change in heart rate over time | 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) | Variation of heart rate measured between four time points. |
| Change in patient's anxiety over time | 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. | 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. |
| Incidence of cybersickness | From the beginning to the end of the pre-oxygenation period. | Incidence of cybersickness during the pre-oxygenation period in percent (%). |
| Comfort of the anesthetic team during pre-oxygenation | From the beginning to the end of the pre-oxygenation period. | 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). |
| Perceived comfort of the patient during pre-oxygenation | From the beginning to the end of the pre-oxygenation period. | 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). |
| Wake up quality test | From the beginning of the awakening after general anesthesia to the removal of the airway device. | Wake up quality test with a 3-point scale (good, satisfactory, poor). |
| Patient's satisfaction regarding the pre-oxygenation period | From 2 hours after the end of anesthesia to the first day after surgery. | 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) |
| Qualitative post-operative survey regarding patient's experience during pre-oxygenation | From 2 hours after the end of anesthesia to the first day after surgery. | Qualitative post-operative survey with questions about patient's experience during pre-oxygenation. |
| Patient's comfort during pre-oxygenation | During pre-oxygenation (at 2 minutes after pre-oxygenation initiation). | 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). |
Countries
Switzerland
Outcome results
None listed