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

NCT07807462 | Not Yet Recruiting

• 1 other identifier: KY-20260629006-02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum

  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.

  42 days after delivery

Secondary Outcomes (4)

• Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum

  7 days after delivery

• Incidence of Postpartum Depression at 7 and 42 Days

  7 and 42 days after delivery

• Insomnia Severity Index Score at 1, 7, and 42 Days

  1, 7, and 42 days after delivery

• Generalized Anxiety Disorder 7-item Scale Score at 1, 7, and 42 Days

  1, 7, and 42 days after delivery

Study Arms (2)

40Hz Audiovisual Stimulation Group

EXPERIMENTAL

Participants receive three 30-minute sessions of combined 40 Hz flashing light (3900-4000K natural white LED) and synchronized 40 Hz pulsed sound. The first session is initiated immediately after fetal delivery; the second session at 24 hours post-delivery; the third session at 48 hours post-delivery.

Device: 40 Hz Audiovisual Stimulation

Placebo Control Group

PLACEBO COMPARATOR

Participants receive three 30-minute sessions of continuous non-flickering natural white light (same color temperature and appearance as the intervention device) and white noise as auditory stimulus, serving as placebo control.

Device: Placebo Audiovisual Stimulation

Interventions

Placebo Audiovisual Stimulation DEVICE

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.

Placebo Control Group

40 Hz Audiovisual Stimulation DEVICE

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.

40Hz Audiovisual Stimulation Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Study Sites (1)

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Xiaobao Zhang

CONTACT

18961322507; hotdog100@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)