Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07458646

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Surgery Mental Disorders Postoperative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Postoperative Depressive Symptoms

    Time frame: 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.

Secondary outcomes

  1. Incidence of Postoperative Anxiety Symptoms

    Time frame: Within 3 days, 7 days, and at 30 days after surgery

    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).

  2. Incidence of Depressive Symptoms

    Time frame: Postoperative day 7 and 30

    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.

  3. Postoperative Nausea and Vomiting (PONV)

    Time frame: Within 3 days after surgery

    Assessed using a Visual Analogue Scale (VAS, 0-10)

  4. Postoperative Pain Score

    Time frame: Postoperative day 3, 7, and 30

    Assessed using the Numerical Rating Scale (NRS, 0-10).

  5. Postoperative Sleep Quality

    Time frame: Postoperative day 3, 7, and 30

    Assessed using the Insomnia Severity Index (ISI, score 0-28).

  6. Time to First Postoperative Flatus and Defecation

    Time frame: From end of surgery until first occurrence, assessed up to 7 days

    Time to First Postoperative Flatus and Defecation

  7. Postoperative Recovery Quality

    Time frame: Postoperative day 3, 7, and 30

    Assessed using the Quality of Recovery-15 or QoR-40 scale.

  8. Postoperative Quality of Life

    Time frame: Postoperative day 3, 7, and 30

    Assessed using the EQ-5D-5L scale.

Other outcomes

  1. Length of Hospital Stay

    Time frame: 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)

    Length of Hospital Stay

  2. Postoperative Complications

    Time frame: From surgery completion to hospital discharge or up to 30 days postoperatively

    Incidence of complications such as respiratory failure, stroke, acute kidney injury, etc.

  3. CRP

    Time frame: Preoperative day, end of surgery, postoperative day 1

    Perioperative Serum Biomarker: C-Reactive Protein (CRP) Levels

  4. IL-6

    Time frame: Preoperative day, end of surgery, postoperative day 1

    Perioperative Serum Biomarker: Interleukin-6 (IL-6) Levels

  5. S100β

    Time frame: Preoperative day, end of surgery, postoperative day 1

    Perioperative Serum Biomarker: S100β Protein Levels

  6. BDNF

    Time frame: Preoperative day, end of surgery, postoperative day 1

    Perioperative Serum Biomarker: Brain-Derived Neurotrophic Factor (BDNF) Levels

  7. IL-10

    Time frame: Preoperative day, end of surgery, postoperative day 1

    Perioperative Inflammatory Cytokine: Interleukin-10 (IL-10) Levels

  8. Adverse Events Related to taVNS

    Time frame: From stimulation start to postoperative day 3

    Adverse Events Related to taVNS

  9. Postoperative Mortality

    Time frame: 7 days and 30 days after surgery

    Postoperative Mortality

  10. Arterial Blood Pressure

    Time frame: Perioperative period

    Perioperative Arterial Blood Pressure

  11. Perioperative Electroencephalogram (EEG) Data

    Time frame: Intraoperative period

    Including Ai (0-100), EMG index, BSR, SEF95, α/β/γ band power.

  12. Heart Rate

    Time frame: Perioperative period

    Perioperative Heart Rate

Study contacts

Contact information is provided by the study sponsor or research team.

Weidong Mi

CONTACT

[email protected]

13381082966

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tiantan Hospital
  • Peking University Shougang Hospital

Registry information

Official study title

Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.