Clinical Study on Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Prevention and Treatment of Perioperative Sleep Disturbances in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
- 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. 2. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Zheng Guo
Professor
Second Hospital of Shanxi Medical University