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临床试验/NCT06333639
NCT06333639已完成不适用

Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

研究概览

简要总结

"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patient 18 years of age or older
  • Patient admitted for total hip or knee replacement surgery.
  • Patient undergoing anaesthetic management by loco-regional anaesthesia
  • Affiliation to a French health insurance scheme or equivalent
  • Patient who has given his non-opposition agreement

排除标准

  • Patient with a neurological disorder (coma, dementia, confusion, photosensitive epilepsy)
  • Patient with a severe psychiatric disorder
  • Patients with severe deafness or visual impairment
  • Language barrier
  • Pregnant or breast-feeding women of childbearing age
  • Refusal of patient involvement

结局指标

主要结局

To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

时间窗: Immediate post-operative

Patient satisfaction with their surgical experience. This will be measured using a Likert scale, graduated from 0 to 10, with 0 being the minimum and 10 the maximum.

次要结局

  • 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset.(Immediate post-operative)
  • Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality(Immediate post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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