Virtual RealityNCT06823141
Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia
A study testing Virtual reality immersion in people with Virtual Reality and Pre-oxygenation, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Pre-oxygenation, Anxiety
- What is being tested?
- Virtual reality immersion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jan 2025to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Virtual Reality, Pre-oxygenation, Anxiety
- Being tested
- Virtual reality immersion
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality immersionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality arm | Experimental | Not described Receives: Device: Virtual reality immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 min after the beginning of pre-oxygenation.
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: During pre-oxygenation (at 2 minutes after pre-oxygenation initiation).
Incidence of cybersickness
Incidence of cybersickness during the pre-oxygenation period in percent (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: From 2 hours after the end of anesthesia to the first day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start24 Jan 2025
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schlotterbeck Hervé, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823141
- Sponsor's protocol ID
- ID 2024-02157
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Immersion on Patient's Anxiety During Pre-oxygenation Before General Anaesthesia: a Pilot Study
- ClinicalTrials.gov ID
- NCT06823141
- Acronym / sponsor ID
- ID 2024-02157
- Conditions
- Virtual Reality, Pre-oxygenation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality arm | Experimental | Device: Virtual reality immersion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality immersionThe 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. | Device | Virtual reality arm |
Primary outcome
Patient's Anxiety during pre-oxygenation
Time frame: 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).
14 secondary outcomes
Change in patient's anxiety over time
Time frame: 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
Time frame: During study recruitment.
Completed pre-oxygenation with virtual reality headset
Time frame: From the beginning to the end of the pre-oxygenation period.
Anxiety evaluation with the Amsterdam Preoperative Anxiety and Information scale (APAIS) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During pre-oxygenation (at 2 minutes after pre-oxygenation initiation).
Incidence of cybersickness
Time frame: From the beginning to the end of the pre-oxygenation period.
Comfort of the anesthetic team during pre-oxygenation
Time frame: From the beginning to the end of the pre-oxygenation period.
Perceived comfort of the patient during pre-oxygenation
Time frame: From the beginning to the end of the pre-oxygenation period.
Wake up quality test
Time frame: From the beginning of the awakening after general anesthesia to the removal of the airway device.
Patient's satisfaction regarding the pre-oxygenation period
Time frame: 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
Time frame: From 2 hours after the end of anesthesia to the first day after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality immersion in people with Virtual Reality and Pre-oxygenation, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Anxiety during pre-oxygenation (time frame: 4 min after the beginning of pre-oxygenation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.