NCT07450456招募中不适用
Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery
Ente Ospedaliero Cantonale, Bellinzona1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention
研究概览
简要总结
This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •All patients undergoing elective surgery
- •Minimal age of 18-year-old
- •Able to give informed consent for the study
- •Requesting pharmacological premedication in the pre-operative period.
排除标准
- •Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
- •Contraindications to pharmacological premedication
- •Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
- •Non Italian speaking patients
- •Injuries to the head/face that would prohibit wearing headsets
- •Infectious skin conditions of the head/face
- •Contact isolation due to bacteria and viruses
- •Symptoms of vertigo or motion sickness
- •Reduced visual or auditory acuity
- •Pregnancy
- •Claustrophobia
研究组 & 干预措施
Virtual reality arm
Experimental
干预措施: Virtual Reality (Device)
结局指标
主要结局
Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention
时间窗: Up to the initiation of pre-oxygenation (same day)
次要结局
- Richmond Agitation Sedation Score (RAAS)(Prior to initiation of pre-oxygenation (intraoperative period, same day))
- Evaluation of Pa02 and PaC02 in theater(Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day))
- External evaluation of patient's comfort(At end of induction, after airway securement (same day))
- Post-operative qualitative survey(From 4 hours after patient's extubation up to 72 hours after patient's extubation)
- Compliance with the VR intervention(From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes))
- Post-operative evaluation of patient's satisfaction regarding pre-operative period(From 4 hours after patient's extubation up to 72 hours after patient's extubation)
- Incidence of cyberslckness(From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention)
- Incidence of secondary effects linked to the use of anxiolytic premedication(From administration of anxiolytic medication until initiation of pre-oxygenation (same day))
- Time to Administration of Anxiolytic Premedication(Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.)
- Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA)(From immediately before VR session to operating room entry (same day))
- Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS)(From immediately before VR session to operating room entry (same day))
- Change in blood pressure over time(From immediately before VR session to operating room entry (same day))
- Change in oxygen saturation over time(From immediately before VR session to operating room entry (same day))
- Change in heart rate over time(From immediately before VR session to operating room entry (same day))
研究者
Schlotterbeck Hervé
Medical Doctor
Ente Ospedaliero Cantonale, Bellinzona
研究点 (1)
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