Transcutaneous Electrical Acupoint Stimulation for Perioperative Sleep Disturbances in Cancer Patients

June 15, 2026 updated by: Zheng Guo, Second Hospital of Shanxi Medical University

Clinical Study on Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Prevention and Treatment of Perioperative Sleep Disturbances in Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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:

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

    Exclusion criteria:

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

  3. 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.

  4. 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.
  5. 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.

Study Type

Interventional

Enrollment (Estimated)

176

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 Contact

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Second Hospital of Shanxi Medical University
        • 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:

  • 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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEAS Intervention Group
Patients receive perioperative TEAS plus standard analgesia
Device: transcutaneous electrical acupoint stimulation,TEAS
TEAS will be applied to LI4, PC6 HT7 and for 30mins preoperatively and continued postoperatively
Sham Comparator: Sham TEAS Control Group
Patients receive sham TEAS plus standard analgesia
Device: Sham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS)
Sham TEAS with identical electrode placement but no electrical stimulation, combined with standard postoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of postoperative sleep quality
Time Frame: 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.
postoperative day 1，postoperative day 3，postoperative day 7，and postoperative day 30

Collaborators and Investigators

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

Sponsor

Second Hospital of Shanxi Medical University

Investigators

  • Study Director: Ying Xiao Zhao, Second Hospital of Shanxi Medical University

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 (Estimated)

June 13, 2026

Primary Completion (Estimated)

July 12, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Zxiaoying20260511

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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