Effect of Virtual Reality Use on Preoperative Anxiety (VeRA)

January 28, 2026 updated by: Vera Guttenthaler

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Virtual reality glasses
Device: Virtual reality glasses
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of randomization until the date of first documented progression, assessed up to 8 hours
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.
From date of randomization until the date of first documented progression, assessed up to 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium incidence in the recovery room
Time Frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
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.
From date of randomization until the date of first documented progression, assessed up to 8 hours
Change of preoperative stress and pain
Time Frame: From date of randomization until the date of first documented progression, assessed up to 8 hours
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."
From date of randomization until the date of first documented progression, assessed up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vera Guttenthaler

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-291-BO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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