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Clinical Trials in China / NCT07458646
Starting soon Not applicable

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Negative Emotions in Breast Cancer Surgery Patients

NCT07458646 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Not applicable
Started
2026-02-28
Last updated
2026-03-09

Condition(s) studied

DepressionPostoperativeAnxietyBreast Surgery

Investigational drug(s) / intervention(s)

Active taVNSSham taVNS

Active taVNS: Stimulation parameters: Amplitude 20 (mA), Frequency 20Hz, Pulse width 200μs, asymmetric biphasic square wave. A single 30-minute stimulation session is applied to the left auricular concha after anesthesia induction.

Sham taVNS: The sham device is identical in appearance, weight, indicator lights, and operation sounds to the active device but delivers no effective electrical current. It is applied to the left auricular concha for 30 minutes after anesthesia induction.

Study summary

A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of a single session of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on perioperative negative emotions (anxiety and depression), pain, nausea, sleep, and recovery in patients undergoing elective breast cancer surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged ≥18 years. Scheduled for elective breast cancer surgery. ASA physical status I-III. Willing and able to provide informed consent. Exclusion Criteria: * Preoperative MMSE score \< 24; severe communication barriers. History of diagnosed dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs. Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials. Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.

Primary outcome measure(s)

  • Incidence of Postoperative Depressive Symptoms — Within 3 days after surgery
    Assessed using the Patient Health Questionnaire-9 (PHQ-9), Hamilton Depression Rating Scale (HAMD-17), and the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). A score above the standard cut-off on any of these scales indicates the presence of depressive symptoms.

Trial sites (2)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing China
First Medical Center of Chinese PLA General Hospital, Beijing, China. Beijing China

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Other trials for the same condition

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Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial Starting soon
Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07458646 on ClinicalTrials.gov ↗ ← All trials in China