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Kaartweergave
Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery (taVNS-MASAnx) 282 Niet-invasief Gerandomiseerd Dubbelblind
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De klinische studie NCT07495163 (taVNS-MASAnx) is een interventioneel studie bij Perioperatieve angst, Grote buikoperatie met de status nog niet rekruterend. De inclusie van 282 deelnemers start op 1 april 2026. De studie wordt geleid door Second Affiliated Hospital, School of Medicine, Zhejiang University en de voltooiing is gepland op 1 februari 2027. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
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...Toon meer
Officiële titel
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
Aandoeningen
Perioperatieve angstGrote buikoperatieAndere studie-ID's
- taVNS-MASAnx
- 2026-0092
NCT-ID
Startdatum (Werkelijk)
2026-04-01
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2027-02-01
Inschrijving (Geschat)
282
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Drievoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve 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. |
Schijncomparatorsham 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 UniversityVerantwoordelijke instantie
yu lina, Hoofdonderzoeker, Chief Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
Centraal Contactpersoon
Contact: Lina Yu, M.D., 8613958033387, [email protected]
4 Studielocaties in 1 landen
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]