Perinatal psychiatric disorders
Conditions
Interventions
Experimental group B (BBM independent intervention group):Perioperative binaural noise-canceling headphones with listening to BBM
Control group C (Blank sound control group):Perioperative binaural noise-canceling headphones with listening to blank sound
Experimental group BK (BBM +esketamine intervention group):Perioperative binaural noise-canceling headphones with listening to BBM and 0.25 mg/kg esketamine intravenous pumped
Control group CK (Blank sound +esketamine intervention group):Perioperative binaural noise-canceling headphones with listening to blank sound and 0.25 mg/kg esketamine intravenous pumped
Group B0K0 (Blank sound + normal saline group):Perioperative binaural noise-canceling headphones with listening to blank sound and normal saline intravenous pumped
Group B0K1 (Blank sound + esketamine group):Perioperative binaural noise-canceling headphones with listening to blank sound and esketamine intravenous pumped
Group B1K0 (BBM + normal saline group):Perioperative binaural noise-canceling headphones with listening to BBM and normal saline intravenous pumped
Group B1K1 (BBM + esketamine group):Perioperative binaural noise-canceling headphones with listening to BBM and esketamine intravenous pumped
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-35 years, ASA class I-II, and body mass index (BMI) of 18.5-30 kg/m2; (2) able to communicate well with the follow-up investigator; and (3) primiparous women with full-term singleton pregnancies who underwent cesarean section under intrathecal anesthesia.
Exclusion criteria
Exclusion criteria: (1) Abnormal electrocardiogram; (2) Hypertension, risk of intracranial hypertension, hyperthyroidism, severe heart disease, or any contraindication to the use of (es)ketamine; (3) any neuropsychiatric disease, dysfunction, or poor compliance; (4) Allergy to (es) ketamine; (5) history of (es)ketamine abuse or dependence; (6) No response to (es) ketamine in any previous trial or there were serious adverse effects; (7) other drug or alcohol dependence; (8) Contraindications to neuraxial anesthesia; (9) Hearing loss or impairment; (10) With obstetric diseases such as preeclampsia, eclampsia, placenta previa, placental abruption or placenta accreta; (11) Insufficient literacy level in reading and writing; (12) Refusal of written informed consent; (13) Participated in other clinical trials within the past 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PPD incidence assessed with Edinburgh Postnatal Depression Scale (EPDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Edinburgh Postnatal Depression Scale (EPDS) depression scale score;Self-Rating Anxiety Scale;Athens Insomnia Scale;Numerical rating scale for pain assessing;Postoperative self-controlled analgesic pump use (number of compressions, total amount of medication, rescue medication, etc.);Blood interleukin-1ß (IL-1ß) levels;Blood interleukin-6 (IL-6) levels;Blood brain-derived neurotrophic factor (BDNF) levels;Infant health status (30 days after birth);Patient satisfaction;Blood C-reactive protein (CRP) levels;Blood TNF-a levels; | — |
Countries
China
Contacts
Public ContactJie Luo
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed