Effects of VR on Preanesthetic Anxiety
2026年6月30日 更新者:Mackay Memorial Hospital
Effects of Virtual Reality Intervention on Anxiety and Uncertainty Before General Anesthesia Among Patients Undergoing Laparoscopic Cholecystectomy
In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery.
However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia.
This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience.
Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care.
Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features.
It has been widely applied in fields such as education, psychotherapy, and healthcare education.
By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia.
This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety.
The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia.
This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group.
Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery.
The video introduced the operating room environment and anesthesia procedures.
The control group received only the printed educational materials.
Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale [APAIS], Anxiety Visual Analogue Scale [VAS]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators.
Assessments were conducted before and after the intervention to evaluate its effectiveness.
This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability.
The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education.
Furthermore, the results can serve as a reference for developing diversified patient education models in the future.
研究概览
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Shu Fen Shen, Ph.D
- 电话号码:1312 +886-2-2636-0300
- 邮箱:shufen@mmu.edu.tw
学习地点
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New Taipei City、台湾
- MacKay Memorial Hospital, Tamsui Branch
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接触:
- Shu Fen Shen, Ph.D
- 电话号码:1312 +886-2-2636-0300
- 邮箱:shufen@mmu.edu.tw
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged 18 years or older.
- Able to communicate in Mandarin Chinese or Taiwanese and complete questionnaires.
- ASA Physical Status I-II.
- Hospitalized one day before surgery.
- No previous experience with general anesthesia.
- Scheduled for laparoscopic cholecystectomy under general anesthesia with endotracheal intubation.
Exclusion Criteria:
- Psychiatric disorders.
- Emergency surgery.
- Visual or hearing impairment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Virtual Reality Education Group
Participants receive a virtual reality-based preoperative educational intervention before general anesthesia.
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Participants receive a single session of virtual reality-based preoperative education before undergoing laparoscopic cholecystectomy under general anesthesia.
The virtual reality program presents information about the surgical procedure, operating room environment, anesthesia induction and recovery process through immersive audiovisual content.
The intervention is designed to improve patient understanding and reduce preoperative anxiety and uncertainty.
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无干预:Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
大体时间:Baseline (before intervention) and Immediately after intervention
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APAIS will be used to measure preoperative anxiety.
Total anxiety scores range from 4 to 20, where higher scores indicate a higher level of preoperative anxiety.
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Baseline (before intervention) and Immediately after intervention
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Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)
大体时间:Immediately after intervention and before anesthesia induction
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VAS is a self-reported scale consisting of a horizontal line.
Scores range from 0 (no anxiety) to 10 (extreme anxiety), where higher scores indicate a higher level of anxiety.
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Immediately after intervention and before anesthesia induction
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
大体时间:Baseline (before intervention) and Immediately after intervention
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The Uncertainty Visual Analogue Scale (VAS) is a self-reported tool used to measure the intensity of preoperative uncertainty.
Scores range from 0 (no uncertainty) to 100 (extreme uncertainty), where higher scores indicate a higher level of preoperative uncertainty.
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Baseline (before intervention) and Immediately after intervention
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Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)
大体时间:Baseline (before intervention) and Immediately after intervention
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IUS-12 will be used to assess the participant's emotional, cognitive, and behavioral reactions to ambiguous situations.
The IUS-12 consists of 12 items with a total score ranging from 12 to 60), where higher scores indicate a lower tolerance for uncertainty (a worse outcome).
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Baseline (before intervention) and Immediately after intervention
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Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System
大体时间:Baseline (before intervention) and Immediately after intervention
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The ProComp Infiniti System (Thought Technology Ltd., distributed by Bio-Medical Instruments) will be used to measure the activation level of low-frequency electroencephalogram (EEG) waves.
An increase in the measured value indicates a higher level of activation of low-frequency brainwaves, which represents an increase in the participant's stress and anxiety levels (a worse outcome).
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Baseline (before intervention) and Immediately after intervention
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Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System
大体时间:Baseline (before intervention) and Immediately after intervention
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The ProComp Infiniti System will be used to measure heart rate variability (HRV) indicators.
Higher HRV values generally represent better autonomic nervous system flexibility and superior stress regulation (a better outcome).
Conversely, lower HRV values are associated with higher levels of stress and anxiety.
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Baseline (before intervention) and Immediately after intervention
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Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale
大体时间:Baseline (before intervention) and Immediately after intervention
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The Chinese version of the Technology Acceptance Model (TAM) scale will be used to evaluate the participants' acceptance of virtual reality technology.
The total score ranges from 11 to 33, with higher scores indicating a higher level of patient acceptance toward virtual reality technology.
This assessment includes dimensions such as behavioral intention to use, perceived usefulness (believing it is helpful), and perceived ease of use (finding operations simple and convenient).
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Baseline (before intervention) and Immediately after intervention
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Participant Satisfaction Assessed by the Patient Satisfaction Scale
大体时间:Immediately after intervention
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Patient Satisfaction Scale will be used to assess the participants' level of satisfaction with the intervention.
The total score ranges from 10 to 50, where a higher score indicates a higher level of satisfaction with the program
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Immediately after intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月9日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月14日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月30日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.