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

September 2, 2026 updated by: The First People's Hospital of Lianyungang

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, randomized clinical trial evaluating whether short-term 40 Hz audiovisual stimulation during and after elective cesarean section can prevent postpartum depression. A total of 204 women (aged ≥18 years, singleton full-term pregnancy, ASA II-III) will be enrolled and randomized 1:1 to intervention or placebo control.

The intervention comprises three 30-minute sessions of combined 40 Hz flashing light and pulsed sound: initiated immediately after fetal delivery, then at 24 and 48 hours post-delivery. The control group receives identical-appearing non-flickering light and white noise. All participants receive standardized multimodal analgesia (epidural morphine 2.0 mg + regular acetaminophen) to minimize pain as a confounding variable.

The primary outcome is EPDS score at postpartum day 42. Secondary outcomes include EPDS at day 7, postpartum depression incidence (EPDS ≥ 10), ISI, and GAD-7 scores at days 1, 7, and 42. Sample size is 204 (102 per group), calculated for 80% power to detect a 2.0-point difference in EPDS (α=0.05, two-sided), accounting for 20% attrition.

Randomization uses block design with concealed allocation. Participants, outcome assessors, and data analysts are blinded. Analysis follows ITT principle, using ANCOVA for the primary outcome and linear mixed models for repeated measures. All participants provide written informed consent.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • The First People's Hospital of Lianyungang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 40Hz Audiovisual Stimulation Group
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
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 Comparator: Placebo Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum
Time Frame: 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.
42 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum
Time Frame: 7 days after delivery
EPDS total score (0-30) assessed at 7 days after delivery.
7 days after delivery
Incidence of Postpartum Depression at 7 and 42 Days
Time Frame: 7 and 42 days after delivery
Proportion of participants with EPDS score ≥ 10 at postpartum day 7 and day 42.
7 and 42 days after delivery
Insomnia Severity Index Score at 1, 7, and 42 Days
Time Frame: 1, 7, and 42 days after delivery
The Insomnia Severity Index (ISI) is a 7-item self-reported questionnaire assessing insomnia severity over the past week. Total score 0-28, higher scores indicate more severe insomnia.
1, 7, and 42 days after delivery
Generalized Anxiety Disorder 7-item Scale Score at 1, 7, and 42 Days
Time Frame: 1, 7, and 42 days after delivery
The GAD-7 is a 7-item self-reported questionnaire assessing anxiety symptoms. Total score 0-21, higher scores indicate more severe anxiety.
1, 7, and 42 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Lianyungang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-20260629006-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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