Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia

Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia: a Pilot Study

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?

Study Overview

• Status: Completed
• Conditions: Anxiety; Virtual Reality; Pre-oxygenation
• Intervention / Treatment: Device: Virtual reality immersion

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Istituto CardioCentro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality arm	Device: Virtual reality immersion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Actual): September 9, 2025
• Study Completion (Actual): September 9, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ID 2024-02157

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No