Virtual reality headsets to reduce anxiety before surgery
Effect of Virtual Reality Use on Preoperative Anxiety: A Prospective, Randomized, Controlled Interventional Study (VeRA-Study)
We will try using a virtual reality headset before elective surgery to see if it lowers anxiety in adult patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bonn Academic / other |
| Locations | 1 site (Bonn) |
| Trial ID | NCT07270445 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled study at University Hospital Bonn comparing preoperative virtual reality headset use to usual care in adults having elective surgery. After informed consent, participants are randomized and stratified by whether relatives are present during the preoperative process. Anxiety is measured with the STOA and APAIS questionnaires, stress and pain with an NRS, simulator sickness with the SSQ, and brain activity is monitored using a BIS EEG device. Key exclusions include epilepsy, certain psychiatric diagnoses, pacemakers/defibrillators, need for sedative premedication, and inability to communicate in German.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective surgery who can read and speak German, have no visual or hearing impairments, and are not receiving sedative premedication are the ideal candidates.
Not a fit: Patients having emergency surgery, with epilepsy or certain psychiatric disorders, with pacemakers/defibrillators, expected ICU/IMC admission, or with communication/visual limitations are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, using a VR headset could lower preoperative anxiety, reduce perioperative stress and pain, and possibly decrease reliance on sedative medications.
How similar studies have performed: Previous smaller randomized trials and reviews in procedural and perioperative settings have shown that VR can reduce anxiety and pain in some patients, but results are variable and larger confirmatory trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bonn
- University of Bonn — Bonn, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.