Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

NCT07495163 | Not Yet Recruiting

• 1 other identifier: 2026-0369
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 4

Brief 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

Major Abdominal Surgery; Perioperative Anxiety

Outcome Measures

Primary Outcomes (1)

• Incidence of perioperative anxiety

  Incidence of perioperative anxiety from the day of surgery through 72 hours postoperatively, as assessed by the 14-item Hamilton Anxiety Rating Scale (HAMA-14).

  From the day of surgery through 72 hours postoperatively following the completion of the intervention

Secondary Outcomes (10)

• Severity and scores of perioperative anxiety

  Within one month postoperatively

• Severity and scores of perioperative depression

  Within one month postoperatively

• Sleep Quality

  Within one month postoperatively

• Pain intensity

  Within one month postoperatively

• Incidence of postoperative delirium within the first 7 days after surgery

  Within 7 days postoperatively

Study Arms (2)

taVNS group

ACTIVE COMPARATOR

Participants in the taVNS group will receive 60-minute stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions.

Device: transauricular auricular vagus nerve stimulation

sham group

SHAM COMPARATOR

Participants in the sham group will receive 60-minute sham stimulation sessions daily, starting from two days preoperatively and continuing through the day of surgery, for a total of three sessions.

Device: transauricular auricular vagus nerve stimulation

Interventions

transauricular auricular vagus nerve stimulation DEVICE

Patients will receive three taVNS sessions, with each session lasting 60 minutes.

taVNS group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Between 18 and 85 years.
• Patients undergoing elective major abdominal surgery under general anesthesia, with an anticipated operative duration of ≥ 2 hours and a predicted postoperative length of stay of ≥ 2 days.
• ASA classification I-III.

You may not qualify if:

• Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.
• Pre-existing bradycardia (resting heart rate \< 50 beats/min) or third-degree atrioventricular block.
• Presence of a cardiac pacemaker or other active electronic implants.
• A documented history of traumatic brain injury within the past 6 months.
• Chronic pain or long-term reliance on analgesic medications.
• Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics.
• Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales.
• Women who were pregnant, lactating, or planning to conceive.
• Current enrollment in other interventional clinical trials.
• Anticipated direct transfer to the ICU immediately following surgery.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (4)

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Location

Jiande First People's Hospital

Meicheng, Zhejiang, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.

Hangzhou, China

Location

Central Study Contacts

Lina Yu, M.D.

CONTACT

8613958033387; zryulina@zju.edu.cn

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: Chief Physician

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-03

Locations

CN (4)