NCT07458646

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Depression
• Postoperative
• Anxiety
• Breast Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

2 sites across 1 country: China