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Lo studio clinico NCT07495163 (taVNS-MASAnx) per Ansia perioperatoria, Chirurgia addominale maggiore è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Effect of taVNS on Perioperative Anxiety in Major Abdominal Surgery (taVNS-MASAnx) 282 Non invasivo Randomizzato Doppio cieco
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La sperimentazione clinica NCT07495163 (taVNS-MASAnx) è uno studio interventistico per Ansia perioperatoria, Chirurgia addominale maggiore, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 aprile 2026, con l'obiettivo di raggiungere 282 partecipanti. Sotto la guida di Second Affiliated Hospital, School of Medicine, Zhejiang University, dovrebbe concludersi entro il 1 febbraio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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...Mostra di più
Titolo ufficiale
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Anxiety in Patients Undergoing Major Abdominal Surgery
Patologie
Ansia perioperatoriaChirurgia addominale maggioreAltri ID dello studio
- taVNS-MASAnx
- 2026-0092
Numero NCT
Data di inizio (effettiva)
2026-04-01
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-02-01
Arruolamento (previsto)
282
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivotaVNS 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. |
Comparatore simulatosham 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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 UniversityParte responsabile dello studio
yu lina, Investigatore principale, Chief Physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
Contatti principali dello studio
Contatto: Lina Yu, M.D., 8613958033387, [email protected]
4 Centri dello studio in 1 paesi
Zhejiang
Huzhou Central Hospital, Huzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China
Hongmei Zhou, Contatto, +86-13867300139, [email protected]
Jiande First People's Hospital, Meicheng, Zhejiang, China
Sanyue Wang, Contatto, +86-13968126731, [email protected]
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China., Hangzhou, China
Lina Yu, Contatto, +86-13958033387, [email protected]