[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654948":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":54,"overallOfficials":29,"centralContacts":64,"locations":70,"responsibleParty":87,"collaborators":29,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":29,"eligibilityCriteria":94,"healthyVolunteers":91,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":29,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":29,"overallStatus":107,"whyStopped":29,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"The First People's Hospital of Lianyungang","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum","EPDS total score (0-30) assessed at 7 days after delivery.","7 days after delivery",{"measure":19,"description":20,"timeFrame":21},"Incidence of Postpartum Depression at 7 and 42 Days","Proportion of participants with EPDS score ≥ 10 at postpartum day 7 and day 42.","7 and 42 days after delivery",{"measure":23,"description":24,"timeFrame":25},"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.","1, 7, and 42 days after delivery",{"measure":27,"description":28,"timeFrame":25},"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.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":35,"maskingDescription":29,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nThe 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.\n\nThe 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.\n\nRandomization 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.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47],"Device: 40 Hz Audiovisual Stimulation",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Device: Placebo Audiovisual Stimulation",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":29},"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.",[43],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":29},"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.",[49],[65],{"name":66,"role":67,"phone":68,"phoneExt":29,"email":69},"Xiaobao Zhang","CONTACT","18961322507","hotdog100@163.com",[71],{"facility":5,"status":29,"city":72,"state":73,"zip":29,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Lianyungang","Jiangsu","China","CN",{"type":77,"coordinates":78},"Point",[79,80],119.21556,34.59845,{"lat":80,"lon":79},[83],{"name":84,"role":67,"phone":85,"phoneExt":29,"email":86},"Yuhui Shi","18961329827","shiyuhui1113@163.com",{"type":88,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100654948","effect-of-peripartum-40-hz-audiovisual-stimulation-on-postpartum-depression-in-women-undergoing-elective-cesarean-section-a-randomized-clinical-trial-100654948",false,"NCT07807462","Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Women scheduled for elective cesarean section under combined spinal-epidural anesthesia;\n2. Age ≥ 18 years;\n3. Singleton, full-term pregnancy;\n4. American Society of Anesthesiologists (ASA) physical status II-III.\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent;\n2. Prior or current diagnosis of psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, etc.;\n3. Preoperative Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 or presence of suicidal ideation;\n4. Current use of antidepressants, antipsychotics, or mood stabilizers;\n5. History of epilepsy or seizure-like episodes (any type);\n6. Presence of retinal disease, glaucoma, macular degeneration, cataract, or other ocular conditions that may affect light perception or cause abnormal sensitivity to light stimulation;\n7. Severe pregnancy complications: severe preeclampsia, HELLP syndrome, severe gestational diabetes mellitus with organ complications, significant placental abruption, or placenta previa with bleeding risk;\n8. Allergy to spinal anesthetics (ropivacaine, lidocaine, etc.);\n9. Participation in other interventional studies that may affect psychological status;\n10. Inability to receive light stimulation.","FEMALE","18 Years","49 Years",{"count":99,"type":100},204,"ESTIMATED","INTERVENTIONAL",[103],"NA","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.\n\nThis 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.\n\nIf effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.",[106],"Depression, Postpartum","NOT_YET_RECRUITING","2026-09-02",{"date":110,"type":111},"2026-09-08","ACTUAL",{"date":113,"type":100},"2026-10-01",{"date":115,"type":100},"2027-07-31",{"name":5,"class":6},1]