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

NCT ID: NCT06823141

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2025-09-09

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?

Conditions

Virtual Reality; Pre-oxygenation; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual reality arm

Group Type: EXPERIMENTAL

Virtual reality immersion

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role: lead

Responsible Party

Schlotterbeck Hervé

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituto Cardiocentro

Lugano, Canton Ticino, Switzerland

Countries

Switzerland

Other Identifiers

ID 2024-02157

Identifier Type: -

Identifier Source: org_study_id