Transcutaneous Electrical Acupoint Stimulation for Perioperative Sleep Disturbances in Cancer Patients

NCT07654075 · tracked via the Priya Life Science China tracker

Sponsor

Second Hospital of Shanxi Medical University

Phase

Not applicable

Started

2026-06-13

Last updated

2026-06-17

Condition(s) studied

Postoperative Sleep Disturbance

Investigational drug(s) / intervention(s)

transcutaneous electrical acupoint stimulation,TEASSham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS)

transcutaneous electrical acupoint stimulation,TEAS: TEAS will be applied to LI4, PC6 HT7 and for 30mins preoperatively and continued postoperatively

Sham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS): Sham TEAS with identical electrode placement but no electrical stimulation, combined with standard postoperative analgesia.

Study summary

Postoperative sleep disturbance (POSD) is highly prevalent among cancer patients after tumor resection, affecting 43%-80% of perioperative individuals. Poor sleep aggravates postoperative pain, anxiety and adverse cardiovascular events, hindering postoperative recovery. Conventional hypnotic medicines carry potential risks of drug dependence and respiratory depression.

Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive physical therapy derived from traditional acupuncture, which delivers low-frequency electrical stimulation on acupoints. Previous small-scale researches suggest TEAS may improve perioperative sleep, but high-quality randomized controlled trial evidence for cancer surgical patients is insufficient.

This single-center randomized sham-controlled trial aims to verify whether perioperative TEAS at Shenmen (HT7), Neiguan (PC6) and Hegu (LI4) can improve postoperative sleep quality, relieve surgical pain and regulate stress hormone level. A total of 176 eligible patients aged 18-75 years undergoing elective gastrointestinal or gynecologic cancer resection under general anesthesia will be enrolled and randomly divided into 1:1 intervention group and sham control group. The TEAS group receives acupoint electrical stimulation from pre-anesthesia to the end of surgery, while control group uses identical electrodes without actual electrical output. All subjects receive standardized anesthesia and routine postoperative analgesia. Researchers evaluate primary outcomes including PSQI and AIS sleep scales, alongside secondary indicators such as VAS pain score, QoR-15 and serum cortisol at postoperative Day1, Day3, Day7 and postoperative 30-day follow-up.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients aged between 18 and 75 years old, regardless of gender. * Diagnosed with malignant tumors requiring elective surgery under general anesthesia. * ASA physical status I-III. * Able to understand and complete study-related questionnaires (PSQI, AIS, NRS, etc.). * Voluntarily sign the informed consent form. Exclusion Criteria: * Severe cardiac, hepatic, renal or respiratory dysfunction that affects the implementation of TEAS. * History of psychiatric disorders or use of psychotropic drugs. * History of drug or alcohol abuse. * Presence of infection, skin lesions or contraindications at TEAS acupoints. * Preoperative use of strong opioids (e.g., morphine, oxycodone) for more than 1 week. * Pregnant or lactating women. * Participation in other clinical trials within 3 months prior to enrollment. * Inability to cooperate with the study due to cognitive impairment or language barriers.

Primary outcome measure(s)

Evaluation of postoperative sleep quality — postoperative day 1，postoperative day 3，postoperative day 7，and postoperative day 30
Athens Insomnia Scale (AIS), an 8-item self-reported questionnaire evaluating insomnia severity over the past month. Each item is rated from 0 (no problem) to 3 (severe problem). The total score ranges from 0 to 24, with higher scores indicating greater insomnia severity and poorer sleep quality. A score of ≥6 is commonly used as the cutoff for clinically significant insomnia.

Trial sites (1)

Facility	City	Region	Status
Second Hospital of Shanxi Medical University	Taiyuan	Shanxi

More Second Hospital of Shanxi Medical University trials in China

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC Recruiting

Relationship Between Remimazolam and Etomidate in Induction of General Anesthesia Starting soon

Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section Starting soon

Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in Diabetic Peripheral Neuropathy(DPN): Association With a Target Gene Starting soon

Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients Recruiting

Other trials for the same condition

Effect of Esketamine on Postoperative Sleep in Postmenopausal Women Recruiting

Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654075 on ClinicalTrials.gov ↗ ← All trials in China