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.
Aged ≥18 years. Scheduled for elective breast cancer surgery. ASA physical status I-III. Willing and able to provide informed consent.
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.
Parallel
Active taVNS
DeviceStimulation 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
DeviceThe 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.
Incidence of Postoperative Depressive Symptoms
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.
Incidence of Postoperative Anxiety Symptoms
Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), the Generalized Anxiety Disorder-7 (GAD-7), and the Self-Rating Anxiety Scale (SAS).
Incidence of Depressive Symptoms
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.Higher scores indicate greater severity of depression.
Postoperative Nausea and Vomiting (PONV)
Assessed using a Visual Analogue Scale (VAS, 0-10)
Postoperative Pain Score
Assessed using the Numerical Rating Scale (NRS, 0-10).
Length of Hospital Stay
Length of Hospital Stay
Postoperative Complications
Incidence of complications such as respiratory failure, stroke, acute kidney injury, etc.
CRP
Perioperative Serum Biomarker: C-Reactive Protein (CRP) Levels
IL-6
Perioperative Serum Biomarker: Interleukin-6 (IL-6) Levels
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Chinese PLA General Hospital
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Peking University Shougang Hospital
Collaborator
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