Effect of Virtual Reality Use on Preoperative Anxiety

NCT07270445 | Recruiting DMC

• 1 other identifier: 2025-291-BO
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety

Keywords

VR glasses; anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  From date of randomization until the date of first documented progression, assessed up to 8 hours

• Delirium incidence in the recovery room

  From date of randomization until the date of first documented progression, assessed up to 8 hours

Study Arms (2)

Virtual reality glasses

EXPERIMENTAL

Device: Virtual reality glasses

Control

NO INTERVENTION

Interventions

Virtual reality glasses DEVICE

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.

Virtual reality glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vera Guttenthaler: lead

Study Sites (1)

University of Bonn

Bonn, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Study Coordinator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (1)