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حالة التجربة السريرية NCT07495163 (taVNS-MASAnx) لـ القلق حول الجراحة، جراحة بطنية كبرى هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery (taVNS-MASAnx) ٢٨٢ غير جراحي عشوائية مزدوجة التعمية

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07495163 (taVNS-MASAnx) هي دراسة تدخُّلية لـالقلق حول الجراحة، جراحة بطنية كبرى وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٣ شوال ١٤٤٧ هـ لتجنيد ٢٨٢ مشاركًا. يقودها Second Affiliated Hospital, School of Medicine, Zhejiang University، ومن المتوقع اكتمالها بحلول ٢٤ شعبان ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
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 tran...عرض المزيد
العنوان الرسمي

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

الحالات الطبية
القلق حول الجراحةجراحة بطنية كبرى
معرّفات دراسة أخرى
  • taVNS-MASAnx
  • 2026-0092
NCT معرّف
NCT07495163
تاريخ البدء (فعلي)
2026-04-01
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2027-02-01
عدد المشاركين المخطط لهم
٢٨٢
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
مقارن نشطtaVNS group
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.
transauricular auricular vagus nerve stimulation
Patients will receive three taVNS sessions, with each session lasting 60 minutes.
المقارن الزائفsham group
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.
transauricular auricular vagus nerve stimulation
Patients will receive three sham taVNS sessions, with each session lasting 60 minutes.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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
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
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  1. Age: Between 18 and 85 years.
  2. 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.
  3. ASA classification I-III.

  1. Active skin breakdown, erythema, swelling, infection of the ear, or significant anatomical abnormalities of the external ear.
  2. Pre-existing bradycardia (resting heart rate < 50 beats/min) or third-degree atrioventricular block.
  3. Presence of a cardiac pacemaker or other active electronic implants.
  4. A documented history of traumatic brain injury within the past 6 months.
  5. Chronic pain or long-term reliance on analgesic medications.
  6. Severe neuropsychiatric disorders or chronic use of psychotropic medications, including corticosteroids, antidepressants, or anxiolytics.
  7. Severe cognitive impairment or any condition precluding effective communication or completion of the assessment scales.
  8. Women who were pregnant, lactating, or planning to conceive.
  9. Current enrollment in other interventional clinical trials.
  10. Anticipated direct transfer to the ICU immediately following surgery.
Second Affiliated Hospital, School of Medicine, Zhejiang University logoSecond Affiliated Hospital, School of Medicine, Zhejiang University
الجهة المسؤولة عن الدراسة
yu lina, المحقق الرئيسي, Chief Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
جهة اتصال مركزية للدراسة
جهة اتصال: Lina Yu, M.D., 8613958033387, [email protected]
4 مواقع الدراسة في 1 بلدان

Zhejiang

Huzhou Central Hospital, Huzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China
Hongmei Zhou, جهة اتصال, +86-13867300139, [email protected]
Jiande First People's Hospital, Meicheng, Zhejiang, China
Sanyue Wang, جهة اتصال, +86-13968126731, [email protected]
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China., Hangzhou, China
Lina Yu, جهة اتصال, +86-13958033387, [email protected]