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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorThe First People's Hospital of Lianyungang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: 40Hz Audiovisual Stimulation GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
42 days after delivery

Secondary outcomes

1

Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum

EPDS total score (0-30) assessed at 7 days after delivery.

Time frame
7 days after delivery
2

Incidence of Postpartum Depression at 7 and 42 Days

Proportion of participants with EPDS score ≥ 10 at postpartum day 7 and day 42.

Time frame
7 and 42 days after delivery
3

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

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.

Time frame
1, 7, and 42 days after delivery
4

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

The GAD-7 is a 7-item self-reported questionnaire assessing anxiety symptoms. Total score 0-21, higher scores indicate more severe anxiety.

Time frame
1, 7, and 42 days after delivery

Other outcomes

Sponsors and contacts

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