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

NCT07807462 · tracked via the Priya Life Science China tracker

Sponsor

The First People's Hospital of Lianyungang

Phase

Not applicable

Started

2026-10-01

Last updated

2026-09-08

Condition(s) studied

Depression, Postpartum

Investigational drug(s) / intervention(s)

40 Hz Audiovisual StimulationPlacebo Audiovisual Stimulation

40 Hz Audiovisual Stimulation: A non-invasive device delivering 40 Hz flickering light (3900-4000K correlated color temperature natural white LED) combined with synchronized 40 Hz pulsed sound . The device is secured to the participant's head via an adjustable headband, with light transmitted through closed eyelids and headphones placed over the ears. Each session lasts 30 minutes.

Placebo Audiovisual Stimulation: An identical-appearing non-invasive device delivering continuous non-flickering natural white light (same correlated color temperature 3900-4000K and appearance as the active device) combined with white noise, serving as placebo control. Each session lasts 30 minutes. The device is secured via an adjustable headband with light transmitted through closed eyelids and headphones placed over the ears.

Study summary

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

Sex

FEMALE

Min age

18 Years

Max age

49 Years

Healthy volunteers

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.

Primary outcome measure(s)

Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum — 42 days after delivery
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-reported questionnaire. Each item is scored 0-3, total score 0-30. Higher scores indicate more severe depressive symptoms.

Trial sites (1)

Facility	City	Region	Status
The First People's Hospital of Lianyungang	Lianyungang	Jiangsu

More The First People's Hospital of Lianyungang trials in China

SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer Recruiting

SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC Starting soon

Anesthetic Effect of Ropivacaine on Local Infiltration Anesthesia in Arteriovenous Fistula Surgery Active, not recruiting

Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients Starting soon

Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07807462 on ClinicalTrials.gov ↗ ← All trials in China