AnxietyVeRANCT07270445
Effect of Virtual Reality Use on Preoperative Anxiety
A study testing Virtual reality glasses in people with Anxiety, run by Vera Guttenthaler at 1 site in Germany.
Trial summary
The aim of this study is to investigate the effect of a non-pharmacological intervention-the use of a virtual reality headset-on preoperative anxiety levels in patients. For this purpose, both psychometric instruments (STOA and APAIS questionnaires) and objective physiological and EEG parameters are used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2026to 1 Mar 2027
- 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
- Age ≥ 18 years
- Written informed consent
- All consecutive patients undergoing elective, outpatient, or inpatient surgery
- No communication difficulties (e.g., hearing impairment) and good command of the German language
- No visual impairment
- Planned extubation immediately after surgery
Who cannot join
- Patients undergoing emergency surgery
- Patients with documented psychiatric disorders (e.g., bipolar disorder), confusion, or epilepsy
- Individuals admitted due to a court or official order
- Expected non-compliance with the study protocol
- Expected admission to an intermediate care unit (IMC) or intensive care unit (ICU)
- Patients receiving sedative or anxiolytic medication for premedication
- Patients with pacemakers or defibrillators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Bonn
Bonn, 53127
Dinc, +49228/287 15074, tugce.dinc-dogan@ukbonn.de
About this study
Official title: Effect of Virtual Reality Use on Preoperative Anxiety: A Prospective, Randomized, Controlled Interventional Study (VeRA-Study)
The aim of this study is to investigate the effect of a non-pharmacological intervention-the use of a virtual reality headset-on preoperative anxiety levels in patients. For this purpose, both psychometric instruments (STOA and APAIS questionnaires) and objective physiological and EEG parameters are used. Patients who do not receive any additional intervention will form the control group.
The study was designed as a prospective, randomized, controlled, interventional study at the University Hospital Bonn. Patients aged 18 years and older who are scheduled to undergo elective surgery and who have no visual, hearing, or language impairments will be included in the study.
The primary objective of the study is the reduction of preoperative anxiety. The hypothesis is that preoperative use of the VR headset reduces perioperative anxiety, stress, and pain.
Read the detailed description
The investigators are planning a prospective, randomized controlled study with the aim of reducing patients' preoperative anxiety through VR use and improving postoperative pain and anxiety levels. After obtaining informed consent, patients will be randomly assigned to either the control or the intervention group. Stratification will be performed based on the presence of relatives during the preoperative process (yes/no) to ensure an even distribution of this potential confounding factor.
Patient anxiety will be assessed using the State-Trait Operation Anxiety (STOA) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaires. Stress and pain will be measured using the Numeric Rating Scale (NRS) from 0 to 10. A baseline assessment of simulator sickness will be performed using the Simulator Sickness Questionnaire (SSQ), which evaluates three symptom groups: nausea, oculomotor discomfort, and disorientation.
Following the questionnaires, patients will undergo EEG monitoring using the BIS device (Bispectral Index Monitor). The BIS is a medical monitoring device widely used in anesthesiology to measure anesthesia depth based on EEG data. Different mental states are associated with specific EEG frequency bands (alpha, beta, gamma, delta, and theta), and EEG is a well-established method for evaluating emotions. Alpha waves are linked to increased relaxation and reduced sympathetic arousal, and enhancing alpha waves in neurofeedback therapy has been shown to reduce anxiety. Beta waves are often associated with motor tasks and cognitive processing, and studies have also shown that increased beta activity correlates with higher anxiety levels. Anxiety affects beta activity by shifting power from lower to higher frequencies. All this suggests that a decrease in alpha-beta ratios (ABR) and low-high beta ratios (BR) may indicate the presence of stress and anxiety. EEG monitoring will continue until the first postoperative hour. Continuous EEG recording allows intraoperative and postoperative EEG patterns to be correlated with anxiety scores and postoperative pain.
During the preoperative process, all patients will be monitored for blood pressure, respiratory rate, oxygen saturation, and heart rate. These measurements will be used to objectively document the effects of sympathetic nervous system activation due to anxiety.
The control group will receive routine clinical care, while the intervention group will undergo a 20-minute VR session. During the session, patients will watch videos of natural landscapes and listen to calming music and nature sounds through headphones to promote relaxation. If any discomfort occurs, the session will be immediately stopped. At the end of the VR session, the SSQ will be repeated. Before entering the operating room, anxiety, stress, and pain levels will be assessed again.
During the first postoperative hour, anxiety, stress, pain, and patient satisfaction with the study procedure will be evaluated. Satisfaction with the study and the VR intervention will be measured using the NRS and a satisfaction questionnaire specific to the VR session. Patients will also be assessed for delirium using the Nursing Delirium Screening Scale (Nu-DESC). Throughout the entire process, all patients will be continuously monitored using EEG/BIS.
- Conditions
- Anxiety
- Being tested
- Virtual reality glasses
- Keywords
- VR glasses, anxiety
- 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 glassesDevice
he VR headset creates an immersive environment that allows patients to distance themselves from the real surroundings. Calming visual and auditory stimuli can be presented through the VR headset, promoting relaxation. Initial results have shown that this application can reduce preoperative anxiety and postoperative pain perception in adult patients and may offer a non-pharmacological alternative to benzodiazepines and opioids. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials by Chiu demonstrated a reduction in anxiety in the intervention group among adults, with an effect size of 0.57.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | Not described Receives: Device: Virtual reality glasses |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of anxiety
The STOA evaluates anxiety on two levels: the long-term, personality-related tendency toward surgical anxiety (trait) and the current state of anxiety (state), with cognitive and affective components. The STOA-State scale includes 10 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), yielding a total score of 0-30. The STOA-Trait scale includes 20 items rated from 0 ("Almost never") to 3 ("Almost always"), with a total score of 0-60.
Measured: From date of randomization until the date of first documented progression, assessed up to 8 hours
The change of anxiety
The APAIS is a validated, brief instrument with 20 items, assessing anxiety related to anesthesia and the surgical procedure. Anxiety scores range from 4 (no anxiety) to 20 (high anxiety), and the total score ranges from 6 to 30.
Measured: From date of randomization until the date of first documented progression, assessed up to 8 hours
Secondary outcomes (2)
Change of preoperative stress and pain
The Numeric Rating Scale (NRS) is a measurement tool in which participants indicate the intensity of their stress or pain on a scale from 0 to 10. A score of 0 represents "no stress/pain," while a score of 10 represents "very severe stress/pain."
Measured: From date of randomization until the date of first documented progression, assessed up to 8 hours
Delirium incidence in the recovery room
The NuDESC is a brief, validated tool used to screen for delirium in hospitalized patients. It assesses five key domains: disorientation, inappropriate behavior, inappropriate communication, hallucinations, and psychomotor retardation. Each item is scored from 0 to 2, where 0 indicates "absent," 1 indicates "mild," and 2 indicates "severe." The total score ranges from 0 to 10, with higher scores reflecting greater severity of delirium.
Measured: From date of randomization until the date of first documented progression, assessed up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start28 Jan 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion1 Mar 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vera Guttenthaler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vera Guttenthaler, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270445
- Sponsor's protocol ID
- 2025-291-BO
- Acronym
- VeRA
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Use on Preoperative Anxiety: A Prospective, Randomized, Controlled Interventional Study (VeRA-Study)
- ClinicalTrials.gov ID
- NCT07270445
- Acronym / sponsor ID
- VeRA / 2025-291-BO
- Conditions
- Anxiety
- Keywords
- VR glasses, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Vera GuttenthalerUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Dec 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 aim of this study is to investigate the effect of a non-pharmacological intervention-the use of a virtual reality headset-on preoperative anxiety levels in patients. For this purpose, both psychometric instruments (STOA and APAIS questionnaires) and objective physiological and EEG parameters are used. Patients who do not receive any additional intervention will form the control group.
The study was designed as a prospective, randomized, controlled, interventional study at the University Hospital Bonn. Patients aged 18 years and older who are scheduled to undergo elective surgery and who have no visual, hearing, or language impairments will be included in the study.
The primary objective of the study is the reduction of preoperative anxiety. The hypothesis is that preoperative use of the VR headset reduces perioperative anxiety, stress, and pain.
Detailed description
The investigators are planning a prospective, randomized controlled study with the aim of reducing patients' preoperative anxiety through VR use and improving postoperative pain and anxiety levels. After obtaining informed consent, patients will be randomly assigned to either the control or the intervention group. Stratification will be performed based on the presence of relatives during the preoperative process (yes/no) to ensure an even distribution of this potential confounding factor.
Patient anxiety will be assessed using the State-Trait Operation Anxiety (STOA) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaires. Stress and pain will be measured using the Numeric Rating Scale (NRS) from 0 to 10. A baseline assessment of simulator sickness will be performed using the Simulator Sickness Questionnaire (SSQ), which evaluates three symptom groups: nausea, oculomotor discomfort, and disorientation.
Following the questionnaires, patients will undergo EEG monitoring using the BIS device (Bispectral Index Monitor). The BIS is a medical monitoring device widely used in anesthesiology to measure anesthesia depth based on EEG data. Different mental states are associated with specific EEG frequency bands (alpha, beta, gamma, delta, and theta), and EEG is a well-established method for evaluating emotions. Alpha waves are linked to increased relaxation and reduced sympathetic arousal, and enhancing alpha waves in neurofeedback therapy has been shown to reduce anxiety. Beta waves are often associated with motor tasks and cognitive processing, and studies have also shown that increased beta activity correlates with higher anxiety levels. Anxiety affects beta activity by shifting power from lower to higher frequencies. All this suggests that a decrease in alpha-beta ratios (ABR) and low-high beta ratios (BR) may indicate the presence of stress and anxiety. EEG monitoring will continue until the first postoperative hour. Continuous EEG recording allows intraoperative and postoperative EEG patterns to be correlated with anxiety scores and postoperative pain.
During the preoperative process, all patients will be monitored for blood pressure, respiratory rate, oxygen saturation, and heart rate. These measurements will be used to objectively document the effects of sympathetic nervous system activation due to anxiety.
The control group will receive routine clinical care, while the intervention group will undergo a 20-minute VR session. During the session, patients will watch videos of natural landscapes and listen to calming music and nature sounds through headphones to promote relaxation. If any discomfort occurs, the session will be immediately stopped. At the end of the VR session, the SSQ will be repeated. Before entering the operating room, anxiety, stress, and pain levels will be assessed again.
During the first postoperative hour, anxiety, stress, pain, and patient satisfaction with the study procedure will be evaluated. Satisfaction with the study and the VR intervention will be measured using the NRS and a satisfaction questionnaire specific to the VR session. Patients will also be assessed for delirium using the Nursing Delirium Screening Scale (Nu-DESC). Throughout the entire process, all patients will be continuously monitored using EEG/BIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Device: Virtual reality glasses |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Written informed consent
- All consecutive patients undergoing elective, outpatient, or inpatient surgery
- No communication difficulties (e.g., hearing impairment) and good command of the German language
- No visual impairment
Key exclusion criteria (7 listed)
- Patients undergoing emergency surgery
- Patients with documented psychiatric disorders (e.g., bipolar disorder), confusion, or epilepsy
- Individuals admitted due to a court or official order
- Expected non-compliance with the study protocol
- Expected admission to an intermediate care unit (IMC) or intensive care unit (ICU)
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 glasseshe VR headset creates an immersive environment that allows patients to distance themselves from the real surroundings. Calming visual and auditory stimuli can be presented through the VR headset, promoting relaxation. Initial results have shown that this application can reduce preoperative anxiety and postoperative pain perception in adult patients and may offer a non-pharmacological alternative to benzodiazepines and opioids. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials by Chiu demonstrated a reduction in anxiety in the intervention group among adults, with an effect size of 0.57. | Device | Virtual reality glasses |
Primary outcome
The change of anxiety
Time frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
The STOA evaluates anxiety on two levels: the long-term, personality-related tendency toward surgical anxiety (trait) and the current state of anxiety (state), with cognitive and affective components. The STOA-State scale includes 10 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), yielding a total score of 0-30. The STOA-Trait scale includes 20 items rated from 0 ("Almost never") to 3 ("Almost always"), with a total score of 0-60.
The change of anxiety
Time frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
The APAIS is a validated, brief instrument with 20 items, assessing anxiety related to anesthesia and the surgical procedure. Anxiety scores range from 4 (no anxiety) to 20 (high anxiety), and the total score ranges from 6 to 30.
2 secondary outcomes
Change of preoperative stress and pain
Time frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
Delirium incidence in the recovery room
Time frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
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 29 Jan 2026.
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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 glasses in people with Anxiety, run by Vera Guttenthaler at 1 site in Germany.
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 6 inclusion and 7 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 29 Jan 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 Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of anxiety (time frame: From date of randomization until the date of first documented progression, assessed up to 8 hours). The study lists 2 primary outcomes in all. 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 29 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.