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

NCT06823141 | Completed

• 1 other identifier: ID 2024-02157
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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.

• Success rate in recruiting patients to participate to the study

  During study recruitment.

• Completed pre-oxygenation with virtual reality headset

  From the beginning to the end of the pre-oxygenation period.

• 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.

• 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)

Study Arms (1)

Virtual reality arm

EXPERIMENTAL

Device: Virtual reality immersion

Interventions

Virtual reality immersion 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.

Virtual reality arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Istituto Cardiocentro

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 12, 2025
• Study Start: January 24, 2025
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-08

Locations

CH (1)