Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Incidence of Postoperative Depressive Symptoms
研究概览
简要总结
A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of a single session of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on perioperative negative emotions (anxiety and depression), pain, nausea, sleep, and recovery in patients undergoing elective breast cancer surgery.
详细描述
Patients undergoing breast cancer surgery frequently experience perioperative anxiety and depression, which can adversely affect recovery and quality of life. This study evaluates the efficacy of a single 30-minute intraoperative taVNS session in mitigating these negative emotions and improving postoperative outcomes. Patients will be randomized to receive either active taVNS or sham stimulation after anesthesia induction. The primary outcome is the incidence of depressive symptoms within 3 days postoperatively. Secondary outcomes include anxiety, pain, PONV, sleep quality, and recovery parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged ≥18 years. Scheduled for elective breast cancer surgery. ASA physical status I-III. Willing and able to provide informed consent.
排除标准
- •Preoperative MMSE score < 24; severe communication barriers. History of diagnosed dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.
- •Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.
- •Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.
研究组 & 干预措施
Active taVNS Group
Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery.
干预措施: Active taVNS (Device)
Sham taVNS Group
Patients receiving sham (placebo) stimulation with an identical device during surgery.
干预措施: Sham taVNS (Device)
结局指标
主要结局
Incidence of Postoperative Depressive Symptoms
时间窗: Within 3 days after surgery
Assessed using the Patient Health Questionnaire-9 (PHQ-9), Hamilton Depression Rating Scale (HAMD-17), and the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). A score above the standard cut-off on any of these scales indicates the presence of depressive symptoms.
次要结局
- Incidence of Postoperative Anxiety Symptoms(Within 3 days, 7 days, and at 30 days after surgery)
- Incidence of Depressive Symptoms(Postoperative day 7 and 30)
- Postoperative Nausea and Vomiting (PONV)(Within 3 days after surgery)
- Postoperative Pain Score(Postoperative day 3, 7, and 30)
- Postoperative Sleep Quality(Postoperative day 3, 7, and 30)
- Time to First Postoperative Flatus and Defecation(From end of surgery until first occurrence, assessed up to 7 days)
- Postoperative Recovery Quality(Postoperative day 3, 7, and 30)
- Postoperative Quality of Life(Postoperative day 3, 7, and 30)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital