[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631014":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":86,"collaborators":25,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":25,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":25,"overallStatus":111,"whyStopped":25,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: transauricular auricular vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","transauricular auricular vagus nerve stimulation","Patients will receive three taVNS sessions, with each session lasting 60 minutes.",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Lina Yu, M.D.","CONTACT","8613958033387","zryulina@zju.edu.cn",[36,48,61,74],{"facility":37,"status":25,"city":38,"state":39,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"Huzhou Central Hospital","Huzhou","Zhejiang","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.0933,30.8703,{"lat":46,"lon":45},{"facility":49,"status":25,"city":50,"state":39,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"The Second Affiliated Hospital of Jiaxing University","Jiaxing",{"type":43,"coordinates":52},[53,54],120.75,30.7522,{"lat":54,"lon":53},[57],{"name":58,"role":32,"phone":59,"phoneExt":25,"email":60},"Hongmei Zhou","+86-13867300139","drhongmeizhou@163.com",{"facility":62,"status":25,"city":63,"state":39,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Jiande First People's Hospital","Meicheng",{"type":43,"coordinates":65},[66,67],119.49907,29.54289,{"lat":67,"lon":66},[70],{"name":71,"role":32,"phone":72,"phoneExt":25,"email":73},"Sanyue Wang","+86-13968126731","1501556348@qq.com",{"facility":75,"status":25,"city":76,"state":25,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.","Hangzhou",{"type":43,"coordinates":78},[79,80],120.16142,30.29365,{"lat":80,"lon":79},[83],{"name":84,"role":32,"phone":85,"phoneExt":25,"email":34},"Lina Yu","+86-13958033387",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","yu lina","Chief Physician","100631014","effect-of-tavns-on-perioperative-anxiety-in-major-abdominal-surgery-100631014",false,"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","taVNS-MASAnx","Inclusion Criteria:\n\n1. Age: Between 18 and 85 years.\n2. 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.\n3. ASA classification I-III.\n\nExclusion Criteria:\n\n1. Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.\n2. Pre-existing bradycardia (resting heart rate \\\u003C 50 beats\u002Fmin) or third-degree atrioventricular block.\n3. Presence of a cardiac pacemaker or other active electronic implants.\n4. A documented history of traumatic brain injury within the past 6 months.\n5. Chronic pain or long-term reliance on analgesic medications.\n6. Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics.\n7. Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales.\n8. Women who were pregnant, lactating, or planning to conceive.\n9. Current enrollment in other interventional clinical trials.\n10. Anticipated direct transfer to the ICU immediately following surgery.","ALL","18 Years","85 Years",{"count":102,"type":103},282,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.",[109,110],"Perioperative Anxiety","Major Abdominal Surgery","NOT_YET_RECRUITING","2026-05-15",{"date":114,"type":115},"2026-05-19","ACTUAL",{"date":117,"type":103},"2026-05-01",{"date":119,"type":103},"2027-02-01",{"name":5,"class":6},4]