[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perioperative-anxiety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perioperative-anxiety":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":21,"type":22},282,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Perioperative Anxiety","Major Abdominal Surgery","NOT_YET_RECRUITING","2026-05-15",{"date":33,"type":34},"2026-05-19","ACTUAL",{"date":36,"type":22},"2026-05-01",{"date":38,"type":22},"2027-02-01",{"name":40,"class":41},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",4,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100613702","sensory-toys-for-anxiety-reduction---can-fidget-toys-improve-stress-and-help-children-to-cope-before-surgery-starfish-100613702","NCT07270029","Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)","STARFISH","Inclusion Criteria:\n\n* Children aged 5-15.99 years of age\n* Children admitted to the day of surgery unit undergoing elective surgery at Perth Children's Hospital or Hospital das Clinicas HCFMUSP as day case surgeries or with a maximum hospital stay of one night postoperatively\n\nExclusion Criteria:\n\n* Children coming for surgery via wards other than the day of surgery unit\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in the care of the child\n* Inability for the child to interact with the sensory toy safely, such as children with severe global developmental delay (GDD).","5 Years","15 Years",{"count":53,"type":22},500,[25],"Anxiety associated with medical procedures is common, with 40-80% of children experiencing significant symptoms and postoperative consequences, including distress and delirium, increased intensity\u002Fduration of pain, prolonged hospital stays, behavioural\u002Fsleep disturbance and avoidance of medical encounters, which often remain into adulthood.\n\nExtensive consumer research has shown that a key priority for Australian consumers of all ages in relation to paediatric hospital care is addressing the fear and anxiety in children throughout the hospital experience (second only to anaesthesia safety for adults and third following anaesthesia safety and pain management for children).\n\nThe STARFISH trial was driven by our consumer partners, particularly our youth consumers. It is well known that distraction is a coping strategy that can help with perioperative anxiety, and all members of the perioperative team commonly employ distraction techniques with patients during routine clinical care. One potential form of distraction involves sensory activities - fidget devices or sensory toys such as spinners, putty, and stability balls are increasingly being used within school settings to help students academically and behaviourally, with applicability for neurodiverse (e.g., autistic, Attention Deficit Hyperactivity Disorder (ADHD)) children being one area of particular interest. However, the research behind sensory toys is inconclusive.\n\nSensory toys have been suggested to our team-from numerous consumers of all ages, including neurodiverse and neurotypical consumers-as a method to reduce anxiety in the preoperative period, thus leading to the design of the STARFISH trial.\n\nThis project aims to assess the use of a sensory toy (of the child's choice) in the perioperative period on the day of surgery to reduce perioperative anxiety and distress.",[28],[58,59,60,61,62,63,64,65],"children","pediatrics","surgery","pediatric anaesthesia","anxiety","perioperative anxiety","fidget toys","sensory toys","RECRUITING","2026-03-23",{"date":69,"type":34},"2026-03-24",{"date":71,"type":34},"2026-01-08",{"date":73,"type":22},"2028-12-30",{"name":75,"class":41},"Telethon Kids Institute"]