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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Peking University Shougang Hospital | OTHER |
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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.
Patients undergoing breast cancer surgery frequently experience perioperative anxiety and depression, which can adversely affect recovery and quality of life. This study evaluates the efficacy of a single 30-minute intraoperative taVNS session in mitigating these negative emotions and improving postoperative outcomes. Patients will be randomized to receive either active taVNS or sham stimulation after anesthesia induction. The primary outcome is the incidence of depressive symptoms within 3 days postoperatively. Secondary outcomes include anxiety, pain, PONV, sleep quality, and recovery parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS Group | Experimental | Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery. |
|
| Sham taVNS Group | Sham Comparator | Patients receiving sham (placebo) stimulation with an identical device during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active taVNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 3 days, 7 days, and at 30 days after surgery |
| Incidence of Depressive Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of Hospital Stay | From admission day (Day 0) to discharge day (the time range for calculating Length of Hospital Stay is from the admission day to the discharge day) |
| Postoperative Complications |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Mi | Contact | 13381082966 | wwdd1962@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | China |
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| Sham taVNS | Device | 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. |
|
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 day 7 and 30 |
| Postoperative Nausea and Vomiting (PONV) | Assessed using a Visual Analogue Scale (VAS, 0-10) | Within 3 days after surgery |
| Postoperative Pain Score | Assessed using the Numerical Rating Scale (NRS, 0-10). | Postoperative day 3, 7, and 30 |
| Postoperative Sleep Quality | Assessed using the Insomnia Severity Index (ISI, score 0-28). | Postoperative day 3, 7, and 30 |
| Time to First Postoperative Flatus and Defecation | Time to First Postoperative Flatus and Defecation | From end of surgery until first occurrence, assessed up to 7 days |
| Postoperative Recovery Quality | Assessed using the Quality of Recovery-15 or QoR-40 scale. | Postoperative day 3, 7, and 30 |
| Postoperative Quality of Life | Assessed using the EQ-5D-5L scale. | Postoperative day 3, 7, and 30 |
Incidence of complications such as respiratory failure, stroke, acute kidney injury, etc.
| From surgery completion to hospital discharge or up to 30 days postoperatively |
| CRP | Perioperative Serum Biomarker: C-Reactive Protein (CRP) Levels | Preoperative day, end of surgery, postoperative day 1 |
| IL-6 | Perioperative Serum Biomarker: Interleukin-6 (IL-6) Levels | Preoperative day, end of surgery, postoperative day 1 |
| S100β | Perioperative Serum Biomarker: S100β Protein Levels | Preoperative day, end of surgery, postoperative day 1 |
| BDNF | Perioperative Serum Biomarker: Brain-Derived Neurotrophic Factor (BDNF) Levels | Preoperative day, end of surgery, postoperative day 1 |
| IL-10 | Perioperative Inflammatory Cytokine: Interleukin-10 (IL-10) Levels | Preoperative day, end of surgery, postoperative day 1 |
| Adverse Events Related to taVNS | Adverse Events Related to taVNS | From stimulation start to postoperative day 3 |
| Postoperative Mortality | Postoperative Mortality | 7 days and 30 days after surgery |
| Arterial Blood Pressure | Perioperative Arterial Blood Pressure | Perioperative period |
| Perioperative Electroencephalogram (EEG) Data | Including Ai (0-100), EMG index, BSR, SEF95, α/β/γ band power. | Intraoperative period |
| Heart Rate | Perioperative Heart Rate | Perioperative period |
| First Medical Center of Chinese PLA General Hospital, Beijing, China. | Beijing | China |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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