Transcutaneous Electrical Acupoint Stimulation for Perioperative Sleep Disturbances in Cancer Patients

NCT07654075 | Not Yet Recruiting

• 1 other identifier: Zxiaoying20260511
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Sleep Disturbance

Keywords

postoperative sleep disturbance; transcutaneous electrical acupoint stimulation; cortisol; Shenmen (HT7), Neiguan (PC6), Hegu (LI4)

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative day 1，postoperative day 3，postoperative day 7，and postoperative day 30

Study Arms (2)

TEAS Intervention Group

EXPERIMENTAL

Patients receive perioperative TEAS plus standard analgesia

Device: transcutaneous electrical acupoint stimulation,TEAS

Sham TEAS Control Group

SHAM COMPARATOR

Patients receive sham TEAS plus standard analgesia

Device: Sham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS)

Interventions

transcutaneous electrical acupoint stimulation,TEAS DEVICE

TEAS will be applied to LI4, PC6 HT7 and for 30mins preoperatively and continued postoperatively

TEAS Intervention Group

Sham Transcutaneous Electrical Acupoint Stimulation (Sham TEAS) DEVICE

Sham TEAS with identical electrode placement but no electrical stimulation, combined with standard postoperative analgesia.

Sham TEAS Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Study Officials

• Ying Xiao Zhao

  Second Hospital of Shanxi Medical University

  STUDY DIRECTOR

Central Study Contacts

Ting Wang

CONTACT

+86 18331359550; 1148460358@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 17, 2026
• Study Start: June 13, 2026
• Primary Completion (Estimated): July 12, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)