Depression, Postpartum
Conditions
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.
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.
Interventions
DEVICE40 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.
DEVICEPlacebo 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.
Sponsors
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum | 7 days after delivery | EPDS total score (0-30) assessed at 7 days after delivery. |
| Incidence of Postpartum Depression at 7 and 42 Days | 7 and 42 days after delivery | Proportion of participants with EPDS score ≥ 10 at postpartum day 7 and day 42. |
| Insomnia Severity Index Score at 1, 7, and 42 Days | 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. |
| Generalized Anxiety Disorder 7-item Scale Score at 1, 7, and 42 Days | 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. |
Countries
China
Contacts
CONTACTXiaobao Zhang
Outcome results
None listed