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临床试验/NCT07620821
NCT07620821已完成不适用

A Randomized Controlled Study of Virtual Reality Simulation of Intraoperative Audiovisual Experience to Reduce Anxiety in Cataract Surgery Patients

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
223
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with cataracts in one or both eyes, and planning to undergo surgical treatment
  • Voluntarily participate in this trial and sign the informed consent form.

排除标准

  • 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 topical anesthesia for the 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.

研究组 & 干预措施

VR Intervention Group

Experimental

30 participants receive virtual reality simulation of intraoperative audiovisual experience before the surgery.

干预措施: Virtual reality simulation of intraoperative audiovisual experience (Device)

Usual Care Group (No VR)

No Intervention

Participants with conventional preoperative instructions (no VR video)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiyao Jin

Dr.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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