Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transauricular auricular vagus nerve stimulation, transauricular auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Perioperative Anxiety, Major Abdominal Surgery. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of perioperative anxiety [Time frame: From the day of surgery through 72 hours postoperatively following the completion of the intervention]
Secondary outcome measures (10)
- Severity and scores of perioperative anxiety [Time frame: Within one month postoperatively]
- Severity and scores of perioperative depression [Time frame: Within one month postoperatively]
- Sleep Quality [Time frame: Within one month postoperatively]
- Pain intensity [Time frame: Within one month postoperatively]
- Incidence of postoperative delirium within the first 7 days after surgery [Time frame: Within 7 days postoperatively]
- Frailty score [Time frame: Within one month postoperatively]
- Quality of recovery [Time frame: Within one month postoperatively]
- Opioid consumption within the first 7 postoperative days [Time frame: Within 7 days postoperatively]
- Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation [Time frame: up to 1 month]
- Length of hospital stay [Time frame: up to 1 month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Huzhou Central Hospital — Huzhou
- The Second Affiliated Hospital of Jiaxing University — Jiaxing
- Jiande First People's Hospital — Meicheng
- The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. — Hangzhou
Identifiers
NCT: NCT07495163 · 2026-0369