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Clinical Trial NCT07495163 (taVNS-MASAnx) for Perioperative Anxiety, Major Abdominal Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery (taVNS-MASAnx) 282 Non-Invasive Randomized Double-Blind
Clinical Trial NCT07495163 (taVNS-MASAnx) is an interventional study for Perioperative Anxiety, Major Abdominal Surgery and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 282 participants. Led by Second Affiliated Hospital, School of Medicine, Zhejiang University, this study is expected to complete by 1 February 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
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...Show More
Official Title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
Conditions
Perioperative AnxietyMajor Abdominal SurgeryOther Study IDs
- taVNS-MASAnx
- 2026-0092
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-02-01
Enrollment (Estimated)
282
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatortaVNS 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. |
Sham Comparatorsham 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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 UniversityStudy Responsible Party
yu lina, Principal Investigator, Chief Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Central Contact
Contact: Lina Yu, M.D., 8613958033387, [email protected]
4 Study Locations in 1 Countries
Zhejiang
Huzhou Central Hospital, Huzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China
Hongmei Zhou, Contact, +86-13867300139, [email protected]
Jiande First People's Hospital, Meicheng, Zhejiang, China
Sanyue Wang, Contact, +86-13968126731, [email protected]
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China., Hangzhou, China
Lina Yu, Contact, +86-13958033387, [email protected]