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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Percutaneous Acupoint Acupuncture
  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 lif
• Другое Sham Acupuncture
  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. Th

Первичные конечные точки

• Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS) [Срок оценки: Postoperative days 1, 2, and at hospital discharge (day 3-5)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai First People's Hospital — Шанхай
• Shanghai First People's Hospital — Шанхай

Идентификаторы

NCT: NCT07662733 · [2026]No.319 · Yuan Lun Kuai 【2026】No.319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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