[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553558":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":41,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":25,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Taipei Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"sleep intervention","EXPERIMENTAL","Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers.",[13],"Behavioral: sleep intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.",[19],"Behavioral: Control group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Control group","Participants in control group will follow standardized usual care and a perinatal health booklet",[15],[31],{"name":32,"affiliation":5,"role":33},"Shu-Yu Kuo, Phd","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Shu-Yu Kuo","CONTACT","+886-2-2736-1661","6301","sykuo@tmu.edu.tw",{"type":42,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100553558","the-development-and-evaluation-of-sleep-intervention-for-perinatal-family-100553558",false,"NCT06487650","The Development and Evaluation of Sleep Intervention for Perinatal Family","Inclusion Criteria:\n\n1. First-time mothers and their partners aged 20 and older;\n2. Currently 30 weeks gestation or more, singleton;\n3. insomnia severity index score greater than 10;\n4. living with a husband or partner;\n5. Both women and their partners are willing to participate in and adhere to the research protocol;\n6. be able to read and speak the Mandarin language\n\nExclusion Criteria:\n\n1. sleep disorders, depression or anxiety disorders;\n2. medical diseases with abnormal heart rate variability, or arrhythmia;\n3. taking medicines that may affect the autonomic nervous system or\n4. night shift workers;\n5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;\n6. infants with fetal deformity, or neonatal complications;\n7. no access to Internet resources",true,"ALL","20 Years",{"count":53,"type":54},600,"ESTIMATED","INTERVENTIONAL",[57],"NA","Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.\n\nObjectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.\n\nMethods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.\n\nAnticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.",[60,61,62],"Sleep","Psychological Distress","Perinatal Problems",[64,65,66,67,68,69],"sleep quality","perinatal","depression","anxiety","infant sleep","infant health","NOT_YET_RECRUITING","2025-01-12",{"date":73,"type":74},"2025-01-14","ACTUAL",{"date":76,"type":54},"2025-12",{"date":78,"type":54},"2026-09",{"name":5,"class":6}]