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Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial

NCT07807462

Not Yet RecruitingNA

Sponsor: The First People's Hospital of Lianyungang

Conditions: Depression, Postpartum

Interventions: 40 Hz Audiovisual Stimulation, Placebo Audiovisual Stimulation

Countries: China

Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments. This study evaluates whether short-term 40 Hz light and sound stimulation during and immediately after elective cesarean section can reduce PPD risk. The intervention group receives three 30-minute sessions of combined 40 Hz flashing light and pulsed sound (starting after baby delivery, then at 24 and 48 hours postpartum). The control group receives identical non-flickering light and white noise as placebo.The main outcome is the Edinburgh Postnatal Depression Scale score at 42 days postpartum. Secondary outcomes include depression rates, insomnia severity, and anxiety levels.Participants are women aged ≥18 years with single full-term pregnancy scheduled for elective cesarean section. Exclusion criteria include psychiatric disorders, epilepsy, or eye conditions affecting light sensitivity. If effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 49 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Women scheduled for elective cesarean section under combined spinal-epidural anesthesia;
2. Age ≥ 18 years;
3. Singleton, full-term pregnancy;
4. American Society of Anesthesiologists (ASA) physical status II-III.

Exclusion Criteria:

1. Refusal to sign informed consent;
2. Prior or current diagnosis of psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, etc.;
3. Preoperative Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 or presence of suicidal ideation;
4. Current use of antidepressants, antipsychotics, or mood stabilizers;
5. History of epilepsy or seizure-like episodes (any type);
6. Presence of retinal disease, glaucoma, macular degeneration, cataract, or other ocular conditions that may affect light perception or cause abnormal sensitivity to light stimulation;
7. Severe pregnancy complications: severe preeclampsia, HELLP syndrome, severe gestational diabetes mellitus with organ complications, significant placental abruption, or placenta previa with bleeding risk;
8. Allergy to spinal anesthetics (ropivacaine, lidocaine, etc.);
9. Participation in other interventional studies that may affect psychological status;
10. Inability to receive light stimulation.

Locations (1)

Lianyungang, Jiangsu, China