Effect of Using Virtual Reality on Intraoperative Anxiolysis and Postoperative Agitation in Older Patients Undergoing Hip Arthroplasty Under Regional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Postoperative Agitation
研究概览
简要总结
This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under regional anesthesia. Half of the patients will experience an immersive, calming nature-based VR environment during the surgery, while the control group will receive standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cemented or uncemented hip arthroplasty under regional (spinal or epidural) anesthesia.
- •ASA physical status I-III.
- •Mentally capable of providing informed consent.
排除标准
- •Pre-existing cognitive impairment or dementia (as assessed by the Mini-Mental State Examination).
- •Severe uncorrected visual or hearing impairments that prevent VR device tolerance.
- •Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- •General contraindications to regional anesthesia (e.g., localized back infection, severe coagulopathy).
- •Inability to physically tolerate or adjust to the VR headset
结局指标
主要结局
Postoperative Agitation
时间窗: From the immediate arrival at the post-anesthesia care unit (PACU) up to 6 hours postoperatively.
Postoperative emergence agitation will be assessed using the unabbreviated Riker Sedation-Agitation Scale (SAS). The score ranges from a minimum value of 1 (unarousable) to a maximum value of 7 (dangerous agitation). A score of 4 indicates a calm and cooperative patient, while scores from 5 to 7 indicate increasing levels of agitation (higher scores mean worse agitation outcomes
Intraoperative Anxiety
时间窗: badeline (Pre-procedure), intraoperatively (every 1 hour), andat 1 hour post-operative
Intraoperative anxiety and sedation levels will be evaluated using the unabbreviated Ramsay Sedation Scale (RSS). The score ranges from a minimum value of 1 (patient anxious and agitated or restless) to a maximum value of 6 (patient asleep with no response). Lower scores indicate higher anxiety and agitation levels, while higher scores indicate deeper sedation and better anxiety control.
次要结局
未报告次要终点
研究者
mostafa saieed fahim mansour
DR
Menoufia University