NCT07458646

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable depression

Timeline
9mo left

Started Feb 2026

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2026

Last Update Submit

March 4, 2026

Conditions

DepressionPostoperativeAnxietyBreast Surgery

Keywords

Transcutaneous Vagus Nerve StimulationBreast Cancer SurgeryDepressionAnxietyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Incidence of Postoperative Anxiety Symptoms

    Within 3 days, 7 days, and at 30 days after surgery

  • Incidence of Depressive Symptoms

    Postoperative day 7 and 30

  • Postoperative Nausea and Vomiting (PONV)

    Within 3 days after surgery

  • Postoperative Pain Score

    Postoperative day 3, 7, and 30

  • Postoperative Sleep Quality

    Postoperative day 3, 7, and 30

  • +3 more secondary outcomes

Other Outcomes (12)

  • 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

    From surgery completion to hospital discharge or up to 30 days postoperatively

  • CRP

    Preoperative day, end of surgery, postoperative day 1

  • +9 more other outcomes

Study Arms (2)

Active taVNS Group

EXPERIMENTAL

Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery.

Device: Active taVNS

Sham taVNS Group

SHAM COMPARATOR

Patients receiving sham (placebo) stimulation with an identical device during surgery.

Device: Sham taVNS

Interventions

Sham taVNSDEVICE

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.

Sham taVNS Group
Active taVNSDEVICE

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.

Active taVNS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years. Scheduled for elective breast cancer surgery. ASA physical status I-III. Willing and able to provide informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hospital

Beijing, China

Location

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

Beijing, China

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Weidong Mi

CONTACT

13381082966wwdd1962@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 9, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)