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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transauricular auricular vagus nerve stimulation | Device | Patients will receive three taVNS sessions, with each session lasting 60 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity and scores of perioperative anxiety | 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) | Within one month postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Yu, M.D. | Contact | 8613958033387 | zryulina@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huzhou Central Hospital | Huzhou | Zhejiang | China | |||
| The Second Affiliated Hospital of Jiaxing University |
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| transauricular auricular vagus nerve stimulation | Device | Patients will receive three sham taVNS sessions, with each session lasting 60 minutes. |
|
| Severity and scores of perioperative depression |
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) |
| Within one month postoperatively |
| Sleep Quality | 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) | Within one month postoperatively |
| Pain intensity | 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) | Within one month postoperatively |
| Incidence of postoperative delirium within the first 7 days after surgery | 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) | Within 7 days postoperatively |
| Frailty score | 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 | Within one month postoperatively |
| Quality of recovery | 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) | Within one month postoperatively |
| Opioid consumption within the first 7 postoperative days | Opioid consumption within the first 7 postoperative days | Within 7 days postoperatively |
| Postoperative recovery: including time to first ambulation, time to first flatus, and time to first defecation | Postoperative recovery milestones: including time to first ambulation, time to first flatus, and time to first defecation | up to 1 month |
| Length of hospital stay | Length of hospital stay | up to 1 month |
| Jiaxing |
| Zhejiang |
| China |
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| Jiande First People's Hospital | Meicheng | Zhejiang | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. | Hangzhou | China |
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