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Not yet recruiting NCT07458646

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

No phase Interventional Depression Postoperative Anxiety Breast Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active taVNS, Sham taVNS.
Who it may be relevant to
Registry conditions: Depression, Postoperative, Anxiety, Breast Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed description

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Incidence of Postoperative Depressive Symptoms [Time frame: Within 3 days after surgery]
Secondary outcome measures (8)
  • Incidence of Postoperative Anxiety Symptoms [Time frame: Within 3 days, 7 days, and at 30 days after surgery]
  • Incidence of Depressive Symptoms [Time frame: Postoperative day 7 and 30]
  • Postoperative Nausea and Vomiting (PONV) [Time frame: Within 3 days after surgery]
  • Postoperative Pain Score [Time frame: Postoperative day 3, 7, and 30]
  • Postoperative Sleep Quality [Time frame: Postoperative day 3, 7, and 30]
  • Time to First Postoperative Flatus and Defecation [Time frame: From end of surgery until first occurrence, assessed up to 7 days]
  • Postoperative Recovery Quality [Time frame: Postoperative day 3, 7, and 30]
  • Postoperative Quality of Life [Time frame: Postoperative day 3, 7, and 30]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing Tiantan Hospital — Beijing
  • First Medical Center of Chinese PLA General Hospital, Beijing, China. — Beijing

Identifiers

NCT: NCT07458646 · PLAGH-RCT-taVNS-BreastCancer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗