Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
研究概览
简要总结
The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed informed consent
- •Patient affiliated with or benefiting from a social security system
- •Patient aged 18 years or older
- •Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb
排除标准
- •Patient refusal to participate in the study
- •Device interfering with the surgical or anesthetic procedure
- •Premedication before arrival in the operating room
- •Psychiatric or cognitive disorders, communication disorders
- •Patient unable to understand the study (language barrier, psychological issues)
- •Emergency surgery
研究组 & 干预措施
Control Group
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.
干预措施: Standard Care (in control arm) (Other)
virtual reality group
Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure.
干预措施: Virtual reality headset (Device)
结局指标
主要结局
Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
时间窗: Intraoperative period (from arrival in the operating room to the end of surgery)
Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale.
次要结局
- Mean age of patients(Baseline (before anesthesia consultation or at inclusion))
- Sex distribution(Baseline (before anesthesia consultation or at inclusion))
- type of surgery(Baseline (before anesthesia consultation or at inclusion))
- ASA score distribution(Baseline (before anesthesia consultation or at inclusion))