Effects of Transcranial Alternating Current Stimulation on Postoperative Anxiety in Patients Undergoing Intraspinal Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Anxiety Within 3 Days After Surgery
研究概览
简要总结
The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery.
The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation.
This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years old
- •Scheduled for elective intraspinal tumor resection under general anesthesia
- •American Society of Anesthesiologists physical status I-III
- •Able to understand and complete the Hospital Anxiety and Depression Scale and other study-related questionnaires
- •Voluntarily sign the informed consent form
- •Right handed
排除标准
- •Preoperative HADS-A score ≥ 8
- •History of psychiatric disorders (e.g., depression, psychosis) or use of psychotropic medications within the past 3 months
- •History of neurological diseases (e.g., epilepsy, stroke, dementia) or severe head trauma
- •Contraindications to transcranial alternating current stimulation, including metallic implants in the head, skull defects, or a history of seizures
- •Severe visual or auditory impairment that affects communication
- •severe cardiovascular and cerebral vascular diseases
- •Participation in other clinical trials within the past 30 days
- •A Mini-Mental State Examination (MMSE) score < 15
结局指标
主要结局
Incidence of Postoperative Anxiety Within 3 Days After Surgery
时间窗: From the day of surgery up to postoperative day 3
The primary outcome is the incidence of postoperative anxiety, defined as a Hospital Anxiety and Depression Scale-Anxiety score ≥ 8 at any time point on the day of surgery or postoperative days 1, 2, or 3. Participants will be assessed by trained evaluators blinded to group allocation.
次要结局
- Severity of postoperative anxiety(1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery)
- Postoperative delirium assessed by 3-minute Diagnostic Confusion Assessment Method score(In the morning (8:00-10:00) and afternoon (16:00-18:00) on the day of surgery and postoperative days 1, 2, 3)
- Postoperative pain intensity assessed by Numeric Rating Scale score(1 day before surgery, 6, 24, 48, and 72 hours after surgery)
- Frailty status assessed by Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight score(1 day before surgery, postoperative days 1, 2, 3, and 3 months after surgery)
- Sleep quality assessed by Pittsburgh Sleep Quality Index score(1 day before surgery, day of surgery, postoperative days 1, 2, 3, and 3 months after surgery)
- Quality of recovery assessed by 15-item Quality of Recovery score(Day of surgery, postoperative days 1, 2, 3, and 1 month after surgery)
- Time to ambulation(Day of surgery, postoperative days 1, 2, 3)
- Length of hospital stay(From the day when patient hospitalization to 3 weeks after surgery)
- Incidence of adverse events, complications, and 30-day all-cause mortality(Up to 30 days after surgery)