[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-sleep-and-crying\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-sleep-and-crying":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100659791","effects-of-two-swaddling-techniques-on-infant-sleep-crying-and-maternal-comfort-100659791",false,"NCT07868380","Effects of Two Swaddling Techniques on Infant Sleep, Crying, and Maternal Comfort","Effects of Two Different Swaddling Techniques on Sleep and Crying Duration in Infants Aged 1-4 Months and Maternal Comfort: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants aged 1-4 months and their mothers.\n* Infants receiving outpatient care at the pediatric outpatient clinic.\n* Infants without anatomical, physiological, or developmental health conditions that would contraindicate swaddling, including developmental dysplasia of the hip, cardiopulmonary disorders, musculoskeletal disorders, or neurological disorders.\n* Infants who have not yet developed the ability to roll from the supine position to either side or to the prone position.\n* Mothers without a diagnosed physical or mental health condition severe enough to interfere with the daily care of their infant.\n* Mothers who provide written informed consent for participation.\n* Mothers who are able to speak and understand Turkish.\n\nExclusion Criteria:\n\n* Infants who, during the study, are diagnosed with a condition for which swaddling is contraindicated and who subsequently require pharmacological or physical treatment related to that condition.\n* Mothers who, during the study, begin pharmacological treatment with analgesic or sedative medications that may affect comfort.","ALL","1 Month","4 Months",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn how two different safe swaddling techniques affect sleep duration, crying duration, and maternal comfort in infants aged 1-4 months and their mothers. The main questions it aims to answer are:\n\n* Do hip-healthy swaddling and midline flexion swaddling affect infants' sleep duration compared with routine care without a study-assigned swaddling intervention?\n* Do hip-healthy swaddling and midline flexion swaddling affect infants' crying duration compared with routine care without a study-assigned swaddling intervention?\n* Do the two swaddling techniques affect mothers' comfort levels compared with routine care? Researchers will compare three groups: hip-healthy swaddling, midline flexion swaddling, and a control group receiving routine care without a study-assigned swaddling intervention. This will help determine whether the two swaddling techniques have different effects on infant sleep and crying duration and maternal comfort.\n\nMothers and infants participating in the study will:\n\n* Be randomly assigned to one of the three study groups.\n* Receive face-to-face training, an educational brochure, and an instructional video on the assigned swaddling technique if allocated to one of the two swaddling groups.\n* Follow the assigned swaddling technique as part of the infant's sleep routine for four weeks if allocated to a swaddling group.\n* Record the infant's sleep and crying durations daily for four weeks using a stopwatch and monitoring forms provided by the researchers.\n* Complete an assessment of maternal comfort at the beginning and end of the study.\n* Have the infant's body weight, length, and head circumference measured at the beginning and end of the study.",[27],"Infant Sleep and Crying",[29,30,31,32,33,34,35],"Swaddling","Infant Sleep","Infant Crying","Maternal Comfort","Infant Care","Hip-Healthy Swaddling","Midline Flexion Swaddling","NOT_YET_RECRUITING","2026-10-09",{"date":39,"type":40},"2026-10-13","ACTUAL",{"date":42,"type":21},"2026-10",{"date":44,"type":21},"2027-08",{"name":46,"class":47},"Izmir University of Economics","OTHER"]