NCT07495163

Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

It is reported that over 50% of patients undergoing major abdominal surgery experience perioperative anxiety, which often triggers a vicious cycle of "anxiety-pain-gastrointestinal dysfunction" and significantly hinders postoperative recovery. Existing pharmacological and psychological interventions are limited by adverse effects such as respiratory depression, paralytic ileus, and poor patient compliance. While transcutaneous auricular vagus nerve stimulation (taVNS) has shown promise as a non-invasive neuromodulation technique for chronic neuropsychiatric disorders, high-quality evidence regarding its application in anxiety-susceptible perioperative populations is still lacking. This multicenter, randomized, parallel-group, double-blind, sham-controlled trial aims to recruit 282 patients undergoing elective major abdominal surgery across four centers in Mainland China. Eligible participants will be randomized (1:1) to receive either taVNS or sham stimulation for 60 minutes daily from two days prior to surgery through the day of the operation. The primary outcome is the incidence of perioperative anxiety from the day of surgery to 72 hours postoperatively, while secondary outcomes include depression, sleep quality, pain intensity, postoperative delirium, frailty scores, quality of recovery, time to first flatus and defecation, and length of hospital stay.

Conditions

• Perioperative Anxiety
• Major Abdominal Surgery

Interventions

Type	Name	Description
DEVICE	transauricular auricular vagus nerve stimulation	Patients will receive three taVNS sessions, with each session lasting 60 minutes.
DEVICE	transauricular auricular vagus nerve stimulation	Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

4 sites across 1 country: China