跳至主要内容
临床试验/NCT07270445
NCT07270445招募中不适用

Effect of Virtual Reality Use on Preoperative Anxiety: A Prospective, Randomized, Controlled Interventional Study (VeRA-Study)

Vera Guttenthaler1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2026年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
172
试验地点
1
主要终点
The change of anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Virtual reality glasses

Experimental

干预措施: Virtual reality glasses (Device)

Control

No Intervention

结局指标

主要结局

The change of anxiety

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Vera Guttenthaler
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vera Guttenthaler

Clinical Study Coordinator

University of Bonn

研究点 (1)

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