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NCT Number: NCT07495163

Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery

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.

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Key information

Conditions

Perioperative Anxiety Major Abdominal Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huzhou Central Hospital, Huzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transauricular auricular vagus nerve stimulation

Device

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

Primary outcomes

  1. Incidence of perioperative anxiety

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

    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).

Secondary outcomes

  1. Severity and scores of perioperative anxiety

    Time frame: Within one month postoperatively

    Perioperative anxiety severity and scores will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11)

  2. Severity and scores of perioperative depression

    Time frame: Within one month postoperatively

    Severity and scores of perioperative depression (HAMD-24) will be evaluated at the following timepoints: pre- and post-intervention (T0-T5); 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and one month post-surgery (T11)

  3. Sleep Quality

    Time frame: Within one month postoperatively

    Sleep Quality (Pittsburgh Sleep Quality Index [PSQI]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11)

  4. Pain intensity

    Time frame: Within one month postoperatively

    Pain Intensity (Numeric Rating Scale[NRS]) will be assessed at the following timepoints: 2 hours post-surgery (T6); postoperative days 1, 2, 3, and 7 (T7-T10); and at the one-month postoperative follow-up (T11)

  5. Incidence of postoperative delirium within the first 7 days after surgery

    Time frame: Within 7 days postoperatively

    Incidence and severity of postoperative delirium (CAM-3D) will be evaluated at the following timepoints: 2 hours post-surgery (T6) and postoperative days 1, 2, 3, and 7 (T7-T10)

  6. Frailty score

    Time frame: Within one month postoperatively

    Frailty Score (The FRAIL Scale [Fatigue, Resistance, Ambulation, Illness, and Loss of Weight]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11). The FRAIL scale assesses five components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight

  7. Quality of recovery

    Time frame: Within one month postoperatively

    Quality of Recovery (Quality of Recovery Scale[QoR-15]) will be evaluated at the following timepoints: postoperative days 1, 3, and 7 (T7, T9, T10), and at the one-month postoperative follow-up (T11)

  8. Opioid consumption within the first 7 postoperative days

    Time frame: Within 7 days postoperatively

    Opioid consumption within the first 7 postoperative days

  9. Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation

    Time frame: up to 1 month

    Postoperative recovery milestones: including time to first ambulation, time to first flatus, and time to first defecation

  10. Length of hospital stay

    Time frame: up to 1 month

    Length of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Yu, M.D.

CONTACT

[email protected]

8613958033387

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: taVNS-MASAnx

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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