Clinical trial · Interventional
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Negative Emotions in Breast Cancer Surgery Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Surgery | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active taVNS | Device | — | UNRESOLVED |
| Sham taVNS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active taVNS Group
- description
- Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery.
- interventionNames
- Device: Active taVNS
- type
- SHAM_COMPARATOR
- label
- Sham taVNS Group
- description
- Patients receiving sham (placebo) stimulation with an identical device during surgery.
- interventionNames
- Device: Sham taVNS
Primary outcomes (1)
- measure
- Incidence of Postoperative Depressive Symptoms
- timeFrame
- Within 3 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available