NCT07662733招募中不适用
Effectiveness of Perioperative Percutaneous Acupoint Acupuncture on Postoperative Sleep Disturbances in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine2 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2025年6月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 2
研究概览
简要总结
This study evaluates whether acupuncture at specific body points before and after surgery can improve sleep quality and reduce long-term postoperative pain in patients undergoing video-assisted thoracoscopic lung cancer resection. Eligible adult patients will be randomly assigned to receive either true acupuncture or sham (placebo) acupuncture in addition to standard care. Chronic pain will be assessed during hospital stay and up to 6 months after surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection.
- •American Society of Anesthesiologists (ASA) physical status classification I-II.
- •Body Mass Index (BMI) between 18.5 and 28 kg/m².
- •Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M
- •Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment.
- •Willing and able to provide written informed consent prior to study participation.
排除标准
- •Critical preoperative condition or inability to cooperate.
- •History of sleep apnea or moderate to severe snoring.
- •Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥
- •Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.
- •Long-term use of anticonvulsants, antidepressants, or other psychotropic medications.
- •Known hypersensitivity or allergy to the study materials (needles/devices) or related medications.
- •Severe cardiac, hepatic, or renal dysfunction.
- •Participation in another clinical trial within the past 3 months.
- •Hearing and/or language communication impairment.
- •Pregnancy or breastfeeding.
- •Fever (body temperature ≥38.5°C) or clinical evidence of infection (hematological, radiological, and/or microbiological) prior to surgery.
- •Planned reoperation, or anticipated postoperative recurrence, severe complications, or critical illness requiring exclusion from follow-up.
研究者
LIna Huang
Chief Physician, Department of Anesthesiology, Shanghai First People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (2)
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