AnxietyNCT07450456
Effect of Virtual Reality on the Need of Premedication Before Surgery
A study testing Virtual Reality in people with Anxiety and Premedication, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Premedication, Surgery
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 patients undergoing elective surgery
- Minimal age of 18-year-old
- Able to give informed consent for the study
- Requesting pharmacological premedication in the pre-operative period.
Who cannot join
- Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
- Contraindications to pharmacological premedication
- Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
- Non Italian speaking patients
- Injuries to the head/face that would prohibit wearing headsets
- Infectious skin conditions of the head/face
Show all 11Show fewer
- Contact isolation due to bacteria and viruses
- Symptoms of vertigo or motion sickness
- Reduced visual or auditory acuity
- Pregnancy
- Claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Istituto Cardiocentro
Lugano, Canton Ticino, 6900
Hervé Schlotterbeck, Medical Doctor, 0041 91 811 51 89, herve.schlotterbeck@eoc.ch
0041 91 811 50 00
About this study
Official title: Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery
This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.
- Conditions
- Anxiety, Premedication, Surgery, Virtual Reality
- Being tested
- Virtual Reality
- 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 RealityDevice
The study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality arm | Experimental | Not described Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention
Measured: Up to the initiation of pre-oxygenation (same day)
Secondary outcomes (14)
Richmond Agitation Sedation Score (RAAS)
The Richmond Agitation-Sedation Scale (RASS) will be used to assess the level of agitation and sedation in study participants. RASS is a validated 10-point scale ranging from -5 (unarousable) to +4 (combative), with 0 representing alert and calm. Negative scores indicate increasing levels of sedation, while positive scores indicate increasing agitation.
Measured: Prior to initiation of pre-oxygenation (intraoperative period, same day)
Evaluation of Pa02 and PaC02 in theater
In the operative room, Pa02 and PaC02 (both in mmHg) will be extracted from the first arterial blood gas after insertion of arterial line while the patient is not under oxygen
Measured: Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)
External evaluation of patient's comfort
External evaluation by the anesthetist team of preceived patient's comfort in theater with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived comfort
Measured: At end of induction, after airway securement (same day)
Post-operative qualitative survey
At least 4 hours after the end of anesthesia and patient's extubation, a qualitative survey will be conducted on patient's experience in the preoperative period
Measured: From 4 hours after patient's extubation up to 72 hours after patient's extubation
Compliance with the VR intervention
Proportion of patients who required the interruption of the VR intervention
Measured: From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)
Post-operative evaluation of patient's satisfaction regarding pre-operative period
Evaluation of patient's satisfaction regarding the pre-operative period with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived level of satisfaction
Measured: From 4 hours after patient's extubation up to 72 hours after patient's extubation
Incidence of cyberslckness
Symptoms of cybersickness such as disorientation, dizziness, eye problems (fatigue, blurred vision, headache) will be monitored
Measured: From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention
Incidence of secondary effects linked to the use of anxiolytic premedication
For patients requesting a premedication, secondary effects like cognitive impairment, sedation, respiratory depressions will be registered
Measured: From administration of anxiolytic medication until initiation of pre-oxygenation (same day)
Time to Administration of Anxiolytic Premedication
After the study intervention, patient will be asked if he still wants to assume anxiolytic premedication. In case of positive answer, anxiolytic premedication will be given and time will be noted. In case of negative answer, no anxiolytic premedication will be given. In the following moments, in case of change in patient's anxiety level with a secondary request of anxiolytic premedication, "rescue" premedication will be given and timing will be noted.
Measured: Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.
Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA)
Change in Visual Analogue Scale for anxiety (VASA) between 3 time points. VASA scale ranges from 0 to10 with 10 corresponding to the highest level of anxiety.
Measured: From immediately before VR session to operating room entry (same day)
Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Change in APAIS scale between 3 time points. 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: From immediately before VR session to operating room entry (same day)
Change in blood pressure over time
Variation of blood pressure (systolic arterial pressure, diastolic arterial pressure, mean arterial pressure) between 3 time points.
Measured: From immediately before VR session to operating room entry (same day)
Change in oxygen saturation over time
Variation of oxygen saturation measured with finger pulsoxymeter between three time points.
Measured: From immediately before VR session to operating room entry (same day)
Change in heart rate over time
Variation of heart rate measured between three time points.
Measured: From immediately before VR session to operating room entry (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start11 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 40 participants (estimated)
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
- NCT07450456
- Sponsor's protocol ID
- ID 2025-01864
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07450456
- Acronym / sponsor ID
- ID 2025-01864
- Conditions
- Anxiety, Premedication, Surgery, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Mar 2026 (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.
This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients undergoing elective surgery
- Minimal age of 18-year-old
- Able to give informed consent for the study
- Requesting pharmacological premedication in the pre-operative period.
Key exclusion criteria (11 listed)
- Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
- Contraindications to pharmacological premedication
- Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
- Non Italian speaking patients
- Injuries to the head/face that would prohibit wearing headsets
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 RealityThe study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible. | Device | Virtual reality arm |
Primary outcome
Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention
Time frame: Up to the initiation of pre-oxygenation (same day)
14 secondary outcomes
Richmond Agitation Sedation Score (RAAS)
Time frame: Prior to initiation of pre-oxygenation (intraoperative period, same day)
Evaluation of Pa02 and PaC02 in theater
Time frame: Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)
External evaluation of patient's comfort
Time frame: At end of induction, after airway securement (same day)
Post-operative qualitative survey
Time frame: From 4 hours after patient's extubation up to 72 hours after patient's extubation
Compliance with the VR intervention
Time frame: From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)
Post-operative evaluation of patient's satisfaction regarding pre-operative period
Time frame: From 4 hours after patient's extubation up to 72 hours after patient's extubation
Incidence of cyberslckness
Time frame: From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention
Incidence of secondary effects linked to the use of anxiolytic premedication
Time frame: From administration of anxiolytic medication until initiation of pre-oxygenation (same day)
Time to Administration of Anxiolytic Premedication
Time frame: Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.
Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA)
Time frame: From immediately before VR session to operating room entry (same day)
Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: From immediately before VR session to operating room entry (same day)
Change in blood pressure over time
Time frame: From immediately before VR session to operating room entry (same day)
Change in oxygen saturation over time
Time frame: From immediately before VR session to operating room entry (same day)
Change in heart rate over time
Time frame: From immediately before VR session to operating room entry (same day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 in people with Anxiety and Premedication, 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hervé Schlotterbeck, Medical Doctor (0041 91 811 51 89, herve.schlotterbeck@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention (time frame: Up to the initiation of pre-oxygenation (same day)). 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 4 Mar 2026.