Effectiveness of Perioperative Percutaneous Acupuncture on Postoperative Sleep Disturbances and Chronic Pain in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial (PASA-VATS)
2026年6月17日 更新者：LIna Huang、Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
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.
研究概览
研究类型
介入性
注册 (估计的)
316
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai、中国
- 招聘中
- Shanghai First People's Hospital
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接触：
- Na li Huang, PhD
- 电话号码：+86-18001780050
- 邮箱：Honilla@163.com
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、201620
- 招聘中
- Shanghai First People's Hospital
-
接触：
- Na li Huang, PhD
- 电话号码：+86-18001780050
- 邮箱：Honilla@163.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria：
- 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-3N0-1M0.
- 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.
Exclusion Criteria：
- 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 ≥6.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Acupuncture Group
Manual acupuncture at HT7, PC6, ST36, KI6 bilaterally before and after surgery; needles retained 30 min with deqi sensation.
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Participants in the acupuncture group will receive manual acupuncture at four bilateral acupoints: Heart 7 (HT7 Shenmen), Pericardium 6 (PC6 Neiguan), Stomach 36 (ST36 Zusanli), and Kidney 6 (KI6 Zhaohai).
Acupuncture will be performed on the night before surgery, on the night of the day of surgery, and on the first postoperative night (total of 3 sessions).
Sterile disposable stainless steel needles (0.25 mm × 40 mm) will be inserted to a depth of 15-25 mm depending on location, with gentle lifting-thrusting and twisting until "Deqi" sensation (aching, heaviness, or tingling) is obtained.
Needles will be retained for 30 minutes, during which manual stimulation will be applied every 10 minutes.
No electrical stimulation will be used.
Standard perioperative care will be provided to all participants.
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安慰剂比较：Sham Acupuncture Group
Non-penetrating placebo needle applied at same acupoints (HT7, PC6, ST36, KI6) with identical procedure and duration; no skin penetration or deqi.
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Participants in the sham acupuncture group will undergo a placebo procedure using non-penetrating sham needles (e.g., Streitberger or similar non-skin-piercing placebo needle) applied at the same acupoints (bilateral HT7, PC6, ST36, KI6) and on the same schedule (the night before surgery, the night of surgery day, and postoperative day 1; total of 3 sessions).
The sham needle tip retracts into the base upon contact with the skin, producing a tactile sensation without skin penetration or Deqi.
The device will be left in place for 30 minutes without manipulation, mimicking the true acupuncture procedure in appearance and duration.
Standard perioperative care will be provided to all participants.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)
大体时间：Postoperative days 1, 2, and at hospital discharge (day 3-5)
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AIS is an 8-item self-report scale.
A total score ≥6 indicates clinically significant insomnia/sleep disturbance.
Higher scores indicate worse sleep quality.
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Postoperative days 1, 2, and at hospital discharge (day 3-5)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年6月13日
初级完成 (估计的)
2027年2月28日
研究完成 (估计的)
2027年11月29日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.