NCT05112302Enrolling By Invitation不适用
Use of Virtual Reality as an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. A Pilot and Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Impact of virtual reality on anxiety level
研究概览
简要总结
The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age ≥ 18 years old.
- •Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty).
- •Subject willing to participate and able to provide informed consent.
排除标准
- •Age < 18 years old.
- •History of motion sickness or blindness.
- •Unable to consent due to cognitive difficulty.
- •Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software.
- •Sensitivity to flashing light or motion.
- •Recent stroke.
- •Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).
结局指标
主要结局
Impact of virtual reality on anxiety level
时间窗: Up to 2 hours
Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures
次要结局
- Impact of virtual reality on patient's perioperative temperature(Up to 3 hours)
- Impact of virtual reality on pharmacological therapy doses(Up to 2 hours)
研究者
Klaus D. Torp
Principal Investigator
Mayo Clinic
研究点 (1)
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