An interventional study of 40 Hz Audiovisual Stimulation and Placebo Audiovisual Stimulation in Depression, Postpartum, sponsored by The First People's Hospital of Lianyungang. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The First People's Hospital of Lianyungang · Not applicable, Interventional, and Prevention
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.
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 204 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →The First People's Hospital of Lianyungang is the lead sponsor of 21 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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
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
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
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
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
Plan to share: No
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Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 7 months is below that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The First People's Hospital of Lianyungang