Clinical trial NCT06823141: Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia
Official title: Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Pre-oxygenation
Anxiety
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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?


Eligibility criteria: 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

Primary outcomes:
measure: Patient's Anxiety during pre-oxygenation
timeFrame: 4 min after the beginning of pre-oxygenation.
Secondary outcomes:
measure: Change in patient's anxiety over time
timeFrame: 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.
measure: Success rate in recruiting patients to participate to the study
timeFrame: During study recruitment.
measure: Completed pre-oxygenation with virtual reality headset
timeFrame: From the beginning to the end of the pre-oxygenation period.
measure: Anxiety evaluation with the Amsterdam Preoperative Anxiety and Information scale (APAIS) score
timeFrame: 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.
measure: Change in blood pressure over time
timeFrame: 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)
measure: Change in oxygen saturation over time
timeFrame: 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)
measure: Change in heart rate over time
timeFrame: 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)
measure: Patient's comfort during pre-oxygenation
timeFrame: During pre-oxygenation (at 2 minutes after pre-oxygenation initiation).
measure: Incidence of cybersickness
timeFrame: From the beginning to the end of the pre-oxygenation period.
measure: Comfort of the anesthetic team during pre-oxygenation
timeFrame: From the beginning to the end of the pre-oxygenation period.
measure: Perceived comfort of the patient during pre-oxygenation
timeFrame: From the beginning to the end of the pre-oxygenation period.
measure: Wake up quality test
timeFrame: From the beginning of the awakening after general anesthesia to the removal of the airway device.
measure: Patient's satisfaction regarding the pre-oxygenation period
timeFrame: From 2 hours after the end of anesthesia to the first day after surgery.
measure: Qualitative post-operative survey regarding patient's experience during pre-oxygenation
timeFrame: From 2 hours after the end of anesthesia to the first day after surgery.
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro
state: Ticino
Study officials:
References: