Postoperative sleep disturbance after cesarean delivery
Conditions
Interventions
Active taVNS group:transcutaneous auricular vagus nerve stimulation
Sponsors
DaZhou Dachuan District People's Hospital China(DaZhou Tihird People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, inclusive; 2. Body mass index (BMI) >18 kg/m^2 and =37 weeks, with a planned elective cesarean delivery under neuraxial anesthesia; 4. American Society of Anesthesiologists (ASA) physical status II–III; 5. No chronic systemic or obstetric comorbidities; alternatively, any existing comorbidities must be clinically stable, not require early termination of pregnancy, and not interfere with the planned elective cesarean delivery; 6. Sufficient basic literacy and comprehension to complete the study questionnaires; 7. The participant and her family members are fully informed about the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Placenta previa, placenta accreta spectrum, or placental abruption; 2. Severe hepatic or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2.5 times the upper limit of normal, total bilirubin >=1.5 times the upper limit of normal, serum creatinine >=1.5 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) =2.5 seconds, or any arrhythmia requiring pharmacological or device-based treatment; 4. Organic brain disease or a history of cranial surgery, including intracranial space-occupying lesions, traumatic brain injury, or cerebrovascular disease; a personal or family history of epilepsy; schizophrenia, bipolar disorder, depressive disorder, or cognitive impairment; or use of antiepileptic, antidepressant, or antipsychotic medications within the preceding 3 months; 5. Any contraindication involving the ear, including metal allergy; congenital abnormalities such as auricular malformations; acquired structural or functional auricular abnormalities that preclude delivery of the intervention, such as auricular trauma, infection, previous surgery, or impaired cutaneous sensation; or severe skin disease, such as severe eczema or dermatitis; 6. Any implanted electronic device, including a cardiac pacemaker or implantable cardioverter-defibrillator, cochlear implant, intracranial or spinal cord stimulation device, any other implanted neurostimulation device, or an implantable electronic infusion pump; 7. Researchers determine that there are other safety or compliance factors that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCSQ score measured on the morning of postoperative day 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Obstetric Quality of Recovery-11 (ObsQoR-11) score on postoperative day 4;Edinburgh Postnatal Depression Scale (EPDS) score on postpartum day 42;Sleep parameters derived from the Consensus Sleep Diary;Hospital Anxiety and Depression Scale score on postoperative day 4;Sleep improvement response rate on postoperative day 4; | — |
Countries
China
Contacts
Public ContactLihong Li
DaZhou Dachuan District People's Hospital China(DaZhou Tihird People's Hospital)
Outcome results
None listed