Transcutaneous Electrical Acupoint Stimulation for Perioperative Sleep Disturbances in Cancer Patients

• Study Design Detail

This is a single-center, prospective, randomized, parallel-group, sham-controlled clinical trial with 1:1 allocation ratio. Randomization will be implemented via sealed opaque envelope method; allocation concealment is strictly performed to avoid selection bias. Blinding settings: patients, outcome assessors and statistical analysts are blinded to group assignment, while operators delivering TEAS cannot be blinded due to operational characteristics. The total planned sample size is 176 subjects, with 88 participants in TEAS intervention group and another 88 in sham control group respectively.

• Full Inclusion & Exclusion Criteria

Inclusion criteria

• Aged between 18-75 years old, ASA physical status grade I-III;
• Scheduled for elective open or laparoscopic gastrointestinal/gynecologic malignant tumor resection under general anesthesia;
• Preoperative Pittsburgh Sleep Quality Index (PSQI) ≥7 points;
• Voluntarily sign written informed consent and agree to complete all scheduled follow-up visits.

Exclusion criteria

• Pre-existing primary sleep apnea, severe insomnia or diagnosed mental sleep disorder;
• Skin lesion, allergy or scar on Shenmen (HT7), Neiguan (PC6), Hegu (LI4) acupoints that cannot paste stimulation electrodes;
• Long-term regular use of sedative-hypnotic drugs or antidepressants within 3 months before surgery;
• Severe hepatic, renal, cardiac or hematological system dysfunction;
• Pregnant or lactating female patients.
• Specific Intervention Protocol

Intervention group: TEAS equipment outputs alternating dense-sparse wave (2Hz/10Hz), electrode pads are fixed bilaterally on Shenmen, Neiguan and Hegu acupoints. Stimulation starts 10 minutes before anesthesia induction and continues uninterruptedly until surgical closure and completion of anesthesia induction; stimulation intensity is adjusted to individual maximum tolerable numbness without obvious pain.

Sham control group: identical electrode placement at same acupoints with same fixing method, but the stimulator keeps zero output current without any electrical stimulation; the duration of electrode wearing is consistent with intervention group.

All enrolled patients receive standardized general anesthesia scheme formulated by department anesthesiologists, as well as unified postoperative intravenous patient-controlled analgesia (PCA) protocol without extra sleep-related drug intervention during trial period.

• Outcome Assessment Timing & Test Specification

All indicators will be assessed at four fixed time points: postoperative day 1 (POD1), postoperative day3 (POD3), postoperative day7 (POD7), postoperative 30-day outpatient follow-up.

• Primary outcomes: PSQI and Athens Insomnia Scale (AIS) filled by patients under unified guidance to quantify sleep quality;
• Secondary outcomes: ① QoR-15 scale for global postoperative recovery assessment; ② resting VAS pain score (0-10 scale); ③ total cumulative PCA analgesic consumption within postoperative 7 days; ④ peripheral venous blood sampling for serum cortisol laboratory testing, samples are preserved at -80℃ uniformly and tested by same laboratory detection kit.
• Statistical Plan

All collected data will be imported into SPSS 26.0 for statistical analysis. Measurement data conforming to normal distribution is expressed as mean±standard deviation and compared via t-test; non-normal data adopts median (interquartile range) with rank-sum test; enumeration data uses chi-square test. P<0.05 is defined as statistically significant difference. Missing data will be processed via intention-to-treat (ITT) analysis principle.

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.