Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of postoperative delirium
研究概览
简要总结
This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients aged 65 and above.
- •Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
- •Patients scheduled for arterial catheterization.
排除标准
- •Patients with uncontrolled systemic conditions such as diabetes and hypertension.
- •Those with visual impairment.
- •Patients with cognitive impairment based on the MMSE-DS criteria.
- •Individuals experiencing difficulty in communication.
- •Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
- •Patients diagnosed with alcohol or substance addiction.
研究组 & 干预措施
control group
The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery.
干预措施: control group (Procedure)
intervention group
For the intervention group, the entire process is carried out according to the Severance Hospital surgical protocol, and the research team provides education before surgery on the importance of nutrition and exercise before and after surgery. In addition, the cognitive training program developed by Rowan is taught with the goal of performing it for at least 10 hours before the surgery, it is conducted the training program after the surgery.
干预措施: intervention group (Procedure)
结局指标
主要结局
incidence of postoperative delirium
时间窗: from postoperative day 0 to postoperative day 7
Confusion assessment methods(CAM) will be used to assess postoperative delirium at least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes, including hallucinations, restlessness, calling out, slowed movement, or lethargy; and emotional disturbances, such as anxiety, irritability, euphoria, apathy, unpredictable mood shift, and personality changes).
次要结局
- type of delirium(from postoperative day 0 to postoperative day 7)
- comprehensive geriatric assessment(CGA),(from postoperative day 0 to postoperative day 7)
- duration of delirium(from postoperative day 0 to postoperative day 7)
- total score of QOR-40(from postoperative day 0 to postoperative day 7)