VR for Cataract Anxiety Lowering Management (VR-CALM)
A Non-Randomized Controlled Trial of Virtual Reality Simulation of Intraoperative Audiovisual Experience to Reduce Anxiety in Cataract Surgery Patients
Cataract is currently the leading cause of blindness globally, and surgery is the only effective treatment. With the advancement of medical technology, cataract surgery is usually performed under topical anesthesia, which means patients will be awake during the procedure, able to see the light from the surgical lamp and hear the sounds of surgical instruments being operated. Some patients may feel nervous or scared due to unfamiliarity with the surgical process, which may lead to increased blood pressure, rapid heartbeat, and even affect their cooperation during the surgery.
Virtual reality (VR) technology is a new multimedia technology. By wearing VR glasses, patients can immerse themselves in a virtual world and see and hear realistic scenes. Through this study, the investigators aim to investigate whether allowing cataract patients to "experience" a surgical procedure in advance through VR glasses before cataract surgery can help alleviate their nervousness during the actual surgery.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200080
- Shanghai General Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment
- Voluntarily participate in this trial and sign the informed consent form.
Exclusion Criteria:
- Having any history of previous ophthalmic surgery.
- Suffering from severe hearing impairment, unable to comprehend VR video content.
- Those who suffer from cognitive dysfunction or mental illness and are unable to cooperate in completing the scale assessment.
- Suffering from severe macular diseases, glaucoma, or other ocular diseases that may affect surgery or interfere with the assessment of tension level.
- Assessed as intolerant to surface anesthesia surgery.
- History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia).
- Other situations where the researcher deems the participant unsuitable for participation in this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：VR Intervention Group
30 participants receive VR simulation of intraoperative audiovisual experience before the surgery.
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This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
其他名称：
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无干预：Usual Care Group (No VR)
Participants with conventional preoperative instructions (no VR)
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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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Intraoperative anxiety numerical rating scale (NRS)
大体时间：collected immediately after the surgery
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Intraoperative participants self-reported anxiety level using numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety)
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collected immediately after the surgery
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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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Pain Numerical Rating Scale (NRS)
大体时间：collected immediately after the surgery
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Intraoperative participants self-reported pain level using numerical rating scale (NRS), from 0 (no pain) to 10 (highest pain)
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collected immediately after the surgery
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Cooperation Numerical Rating Scale (NRS)
大体时间：collected immediately after the surgery
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The numerical rating scale (NRS) score of patient cooperation level assessed by the surgeon, from 0 (very bad cooperation) to 5 (very good cooperation)
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collected immediately after the surgery
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Heart rate
大体时间：collected during the surgery
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Heart rate at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
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collected during the surgery
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Blood Pressure
大体时间：collected during the surgery
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Systolic blood pressure and diastolic blood pressure at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
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collected during the surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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