Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall incidence of PTSD at different time points
研究概览
简要总结
Preoperative anxiety, pain, and repeated exposure to general anesthesia may increase the risk of post-traumatic stress disorder (PTSD) in children. This study aims to establish a clinical database by collecting the incidence and risk factors of PTSD in children aged 6 to 12 undergoing elective surgery under general anesthesia, with a primary focus on evaluating the overall postoperative PTSD incidence, its incidence at different time points, and identifying potential risk factors.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-12 years scheduled for elective surgery under general anesthesia.
- •Parent or legal guardian provides informed consent and agrees to complete a 1-year follow-up.
排除标准
- •History of psychiatric disorders (e.g., PTSD, anxiety disorders), substance abuse, long-term use of steroids or hormonal medications.
- •Significant cognitive impairment that hinders understanding of study procedures.
- •Emergency surgery or trauma-related procedures requiring urgent general anesthesia.
- •Recent (within two weeks) upper respiratory tract infection or severe pulmonary disease.
结局指标
主要结局
Overall incidence of PTSD at different time points
时间窗: 6 months
Morbidity of enrolled children during follow-up assessed by CPSS questionnaire
次要结局
未报告次要终点
研究者
JianHao Zhang
postgraduate student
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College