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)

June 17, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201620
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria：

  1. Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection.
  2. American Society of Anesthesiologists (ASA) physical status classification I-II.
  3. Body Mass Index (BMI) between 18.5 and 28 kg/m².
  4. Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M0.
  5. Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment.
  6. Willing and able to provide written informed consent prior to study participation.

Exclusion Criteria：

  1. Critical preoperative condition or inability to cooperate.
  2. History of sleep apnea or moderate to severe snoring.
  3. Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥6.
  4. Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.
  5. Long-term use of anticonvulsants, antidepressants, or other psychotropic medications.
  6. Known hypersensitivity or allergy to the study materials (needles/devices) or related medications.
  7. Severe cardiac, hepatic, or renal dysfunction.
  8. Participation in another clinical trial within the past 3 months.
  9. Hearing and/or language communication impairment.
  10. Pregnancy or breastfeeding.
  11. Fever (body temperature ≥38.5°C) or clinical evidence of infection (hematological, radiological, and/or microbiological) prior to surgery.
  12. Planned reoperation, or anticipated postoperative recurrence, severe complications, or critical illness requiring exclusion from follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture Group
Manual acupuncture at HT7, PC6, ST36, KI6 bilaterally before and after surgery; needles retained 30 min with deqi sensation.
Other: 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 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.
Placebo Comparator: 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.
Other: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)
Time Frame: Postoperative days 1, 2, and at hospital discharge (day 3-5)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

November 29, 2027

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2026]No.319
  • Yuan Lun Kuai 【2026】No.319 (Other Identifier: Ethics Committee of Shanghai First People's Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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