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临床试验/NCT06822023
NCT06822023尚未招募不适用

Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery

South Tyneside and Sunderland NHS Foundation Trust0 个研究点目标入组 75 人开始时间: 2025年2月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
主要终点
Anxiety score

研究概览

简要总结

This project is to evaluate the benefits of utilising virtual reality (VR) headsets with the aim of reducing peri-operative anxiety in cataract surgery and hence reducing the need for sedation in patients with significant stress levels noted during preassessment. This is a novel study, and with the increased use of VR technology throughout medicine, we may be able to offer our patients alternative management modalities to reduce stress and reduce need for medications with their subsequent potential side effects. It may also improve the quality of care provided and patients' experience with the cataract extraction procedure and might reduce the social care burden associated with standard sedation procedures. All patients will need to fill a quick preoperative anxiety and information scale questionnaire to assess their level of anxiety utilising The Amsterdam Preoperative Anxiety and Information Score.

Patients will be randomised into 2 groups:

  1. Conventional group: patients will be prepared as per the standard routine clinical and further explanation of the procedure will be given. Before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.
  2. Interventional Group: patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. Before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.

Post operation, a record will be taken of the surgeon's decision on whether they want the second eye cataract surgery to be done under sedation (this is already standard practice at our centre). Finally, the patient will be asked to fill in one final grading score on whether they are happy with their decision to take/not take sedation.

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

性别
All
接受健康志愿者

入选标准

  • Patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned.
  • First eye cataract procedures will only be included.
  • Capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire

排除标准

  • severe vertigo
  • poor visual acuity (below 6/60 best corrected in the best seeing eye)
  • significant hearing impairment
  • recent facial injury/burn.

结局指标

主要结局

Anxiety score

时间窗: 10 mins following intervention

Percentage of reduction in Anxiety score in interventional group as compared to control group as assessed using the Amsterdam preoperative anxiety and information score

次要结局

  • Patient required sedation after intervention(10 mins)
  • Patient required sedation for second eye surgery(Following surgery, approximately 30-60 mins following intervention)

研究者

发起方
South Tyneside and Sunderland NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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