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Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Postpartum Depression After Cesarean Delivery

40-Hz Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Postpartum Depression After Cesarean Delivery: A Multicenter, Double-Blind, Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127962
Enrollment
Unknown
Registered
2026-07-10
Start date
2026-07-14
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression (PPD)

Interventions

Sham ta-VNS group:Subjects in the sham stimulation group underwent identical operational procedures with electrodes placed over the left cymba conchae. After completion of the same intensity titration
Ta-VNS group:Subjects in the stimulation group received transcutaneous auricular vagus nerve stimulation applied to the left cymba conchae at a frequency of 40 Hz and a pulse width of 300 µs, delivere

Sponsors

Changzhi Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 45 years inclusive. 2. Gestational age >= 37 weeks. 3. American Society of Anesthesiologists physical status classification (ASA): Grade I–II. 4. Pre-pregnancy body mass index (BMI): 20 kg/m² <= BMI <= 35 kg/m². 5. Capable of understanding the study protocol and all assessment scales, and able to communicate effectively with research staff. 6. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to neuraxial anesthesia, or those who decline neuraxial anesthesia and require cesarean delivery under general anesthesia. 2. Emergency cesarean section. 3. Presence of severe gestational complications (e.g., severe preeclampsia, placenta accreta spectrum, HELLP syndrome, placenta previa, placental abruption, etc.). 4. Refractory hypertension, severe cardiovascular diseases (New York Heart Association functional class = ?), hyperthyroidism, and related disorders. 5. Ongoing medication use that may affect mood or drugs for illnesses associated with mood lability. 6. Subjects who refuse study participation. 7. Other exclusion items: severe physical illness, suicidal ideation, or self-reported current or lifetime major psychiatric disorders (e.g., bipolar disorder, schizophrenia) or prior psychiatric treatments (e.g., anxiolytics, psychotropic medications, psychotherapy).

Design outcomes

Primary

MeasureTime frame
Incidence of postpartum depression at 6 weeks postpartum;

Secondary

MeasureTime frame
Severity of PPD;Postpartum pain and cumulative consumption of opioids;Postoperative sleep quality;Overall severity of PPB;

Countries

China

Contacts

Public ContactWang Guoqiang

Changzhi Maternal and Child Health Care Hospital

1209400368@qq.com+86 355 205 1195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026