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

NCT07662733 | Recruiting

• 2 other identifiers: [2026]No.319Yuan Lun Kuai 【2026】No.319
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Sleep Disturbances; Chronic Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)

  AIS is an 8-item self-report scale. A total score ≥6 indicates clinically significant insomnia/sleep disturbance. Higher scores indicate worse sleep quality.

  Postoperative days 1, 2, and at hospital discharge (day 3-5)

Study Arms (2)

Acupuncture Group

EXPERIMENTAL

Manual acupuncture at HT7, PC6, ST36, KI6 bilaterally before and after surgery; needles retained 30 min with deqi sensation.

Other: Percutaneous Acupoint Acupuncture

Sham Acupuncture Group

PLACEBO COMPARATOR

Non-penetrating placebo needle applied at same acupoints (HT7, PC6, ST36, KI6) with identical procedure and duration; no skin penetration or deqi.

Other: Sham Acupuncture

Interventions

Percutaneous Acupoint Acupuncture OTHER

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.

Acupuncture Group

Sham Acupuncture OTHER

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.

Sham Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

Shanghai First People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Anesthesiology, Shanghai First People's Hospital

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 13, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): November 29, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)