About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
transcutaneous electrical acupoint stimulation,TEAS
DeviceTEAS will be applied to LI4, PC6 HT7 and for 30mins preoperatively and continued postoperatively
Sham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS)
DeviceSham TEAS with identical electrode placement but no electrical stimulation, combined with standard postoperative analgesia.
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of postoperative sleep quality
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.
Sponsors and contacts
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