ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07495163 (taVNS-MASAnx) के लिए परिओपरेटिव चिंता, प्रमुख पेट की सर्जरी वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery (taVNS-MASAnx) 282 गैर-आक्रामक (Non-invasive) रैंडमाइज़्ड डबल-ब्लाइंड
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07495163 (taVNS-MASAnx) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो परिओपरेटिव चिंता, प्रमुख पेट की सर्जरी से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 282 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 अप्रैल 2026 से शुरू होगा। Second Affiliated Hospital, School of Medicine, Zhejiang University इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 फ़रवरी 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 27 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...और दिखाएँ
आधिकारिक शीर्षक
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
स्वास्थ्य स्थितियां
परिओपरेटिव चिंताप्रमुख पेट की सर्जरीअन्य अध्ययन आईडी
- taVNS-MASAnx
- 2026-0092
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-04-01
अंतिम अद्यतन प्रकाशित
2026-03-27
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-02-01
नामांकन (अनुमानित)
282
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
तिहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
सक्रिय तुलना समूहtaVNS 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. |
दिखावटी उपचार तुलना समूहsham 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. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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.
- 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.
Second Affiliated Hospital, School of Medicine, Zhejiang Universityअध्ययन उत्तरदायी पक्ष
yu lina, मुख्य अन्वेषक, Chief Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
अध्ययन केंद्रीय संपर्क
संपर्क: Lina Yu, M.D., 8613958033387, [email protected]
4 1 देशों में अध्ययन स्थान
Zhejiang
Huzhou Central Hospital, Huzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China
Hongmei Zhou, संपर्क, +86-13867300139, [email protected]
Jiande First People's Hospital, Meicheng, Zhejiang, China
Sanyue Wang, संपर्क, +86-13968126731, [email protected]
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China., Hangzhou, China
Lina Yu, संपर्क, +86-13958033387, [email protected]