[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659791":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":56,"overallOfficials":64,"centralContacts":69,"locations":74,"responsibleParty":91,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":30,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":30,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":121,"whyStopped":30,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Izmir University of Economics","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":30},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Infant Sleep Duration","Infant sleep duration will be recorded daily by mothers using a standardized sleep monitoring form and a stopwatch provided by the researchers. Mothers will start the stopwatch when the infant falls asleep and stop it when the infant wakes. Sleep duration will be recorded in minutes for each sleep episode, and daily total sleep duration will be calculated. Daily sleep durations will be recorded throughout the four-week follow-up period and summarized for analysis.","Daily for 4 weeks",{"measure":14,"description":15,"timeFrame":12},"Infant Crying Duration","Infant crying duration will be recorded daily by mothers using a standardized crying monitoring form and a stopwatch provided by the researchers. Mothers will start the stopwatch at the beginning of a crying episode and stop it when the crying episode ends. Crying duration will be recorded in minutes for each crying episode, and daily total crying duration will be calculated. Daily crying durations will be recorded throughout the four-week follow-up period and summarized for analysis.",{"measure":17,"description":18,"timeFrame":19},"Maternal Comfort","Maternal comfort will be assessed using the General Comfort Questionnaire-Short Form. The scale consists of 28 items assessing relief, ease, and transcendence. After reverse coding negatively worded items, item scores are summed and divided by the number of items to obtain a mean score. Scores range from 1 to 6, with higher scores indicating a higher level of comfort.","Baseline and at the end of week 4",[21,24,27],{"measure":22,"description":23,"timeFrame":19},"Change in Infant Body Weight","Infant body weight will be measured using the same calibrated infant scale by the same researcher at baseline and at the end of the four-week follow-up. Body weight will be recorded in grams. Change in body weight from baseline to week 4 will be evaluated.",{"measure":25,"description":26,"timeFrame":19},"Change in Infant Length","Infant length will be measured using the same infant length measurement equipment by the same researcher at baseline and at the end of the four-week follow-up. Length will be recorded in centimeters. Change in length from baseline to week 4 will be evaluated.",{"measure":28,"description":29,"timeFrame":19},"Change in Infant Head Circumference","Infant head circumference will be measured using the same non-stretchable measuring tape by the same researcher at baseline and at the end of the four-week follow-up. Head circumference will be recorded in centimeters. Change in head circumference from baseline to week 4 will be evaluated.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Three-arm parallel randomized controlled trial with two intervention groups and one control group. Participants will be stratified by infant age (1-2 months and 3-4 months) and sex, followed by block randomization within each stratum.","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":38,"whoMasked":30},"NONE","Due to the nature of the behavioral intervention, mothers and researchers providing the swaddling education cannot be blinded to group assignment. Study groups will be coded as A, B, and C for statistical analysis.","Swaddling is a commonly used infant care practice that may promote sleep and soothing when performed using safe techniques. However, inappropriate swaddling practices may restrict hip movement, contribute to overheating, or compromise safe sleep practices. Therefore, this study will compare two swaddling techniques designed to maintain infant safety while differing in positioning: hip-healthy swaddling and midline flexion swaddling.\n\nThis study is designed as a three-arm randomized controlled trial involving mothers and their infants aged 1-4 months attending the pediatric outpatient clinics of Izmir University of Economics Medical Point Hospital. A total of 96 mother-infant dyads are planned to be enrolled, with 32 dyads assigned to each group. Participants will be allocated to the hip-healthy swaddling group, midline flexion swaddling group, or control group using stratified block randomization according to infant age and sex.\n\nIn the hip-healthy swaddling group, mothers will be taught a swaddling technique that allows sufficient space for flexion and movement of the hips and knees while securely wrapping the upper body. In the midline flexion swaddling group, mothers will be taught a technique in which the infant's upper extremities are maintained close to the midline in a flexed position while the hips and knees remain flexed and sufficiently free to move. Both techniques will follow safe swaddling principles, including placing the infant supine, keeping the face and head uncovered, avoiding excessive tightness and overheating, and discontinuing swaddling when the infant shows signs of attempting to roll. The control group will continue routine infant care without a study-assigned swaddling intervention.\n\nMothers in both intervention groups will receive face-to-face instruction, an educational brochure, and an instructional video for the assigned technique. The intervention will be implemented for four weeks. Mothers will be contacted at least weekly during the intervention period to support adherence and safe implementation of the assigned technique.\n\nInfant sleep and crying durations will be monitored daily throughout the four-week study period using standardized recording forms and stopwatches provided by the researchers. Maternal comfort will be evaluated using the General Comfort Questionnaire-Short Form at baseline and at the end of the intervention. Infant body weight, length, and head circumference will be measured at baseline and at the end of the four-week follow-up as secondary outcomes.\n\nThe primary comparison will evaluate differences among the three study groups in infant sleep duration, infant crying duration, and maternal comfort over the study period. Secondary analyses will evaluate changes in infant growth parameters.",[41,47,52],{"label":42,"type":43,"description":44,"interventionNames":45},"Hip-Healthy Swaddling","EXPERIMENTAL","Mothers assigned to this group will receive face-to-face training on hip-healthy swaddling, supported by an educational brochure and instructional video. The technique securely wraps the infant's upper body while allowing sufficient space for the hips and knees to remain flexed and move freely. Mothers will use the assigned swaddling technique as part of the infant's sleep routine for four weeks.",[46],"Behavioral: Hip-Healthy Swaddling",{"label":48,"type":43,"description":49,"interventionNames":50},"Midline Flexion Swaddling","Mothers assigned to this group will receive face-to-face training on midline flexion swaddling, supported by an educational brochure and instructional video. The technique maintains the infant's upper extremities close to the midline in a flexed position while allowing the hips and knees to remain flexed and sufficiently free to move. Mothers will use the assigned swaddling technique as part of the infant's sleep routine for four weeks.",[51],"Behavioral: Midline Flexion Swaddling",{"label":53,"type":54,"description":55,"interventionNames":30},"Routine Care Control","NO_INTERVENTION","Mother-infant dyads assigned to the control group will continue their routine infant care practices and will not receive a study-assigned swaddling intervention during the four-week study period.",[57,61],{"type":58,"name":42,"description":59,"armGroupLabels":60,"otherNames":30},"BEHAVIORAL","Mothers assigned to this intervention will receive face-to-face training on hip-healthy swaddling, supported by an educational brochure and instructional video. The infant will be placed supine and the upper body will be securely wrapped, while sufficient space will be maintained around the hips and legs to allow hip abduction and flexion, knee flexion, and free movement of the lower extremities. The swaddle will allow approximately two-finger space at the chest, and the infant's face and head will remain uncovered. Mothers will apply the technique as part of the infant's sleep routine for four weeks. Safe swaddling principles, including avoiding excessive tightness and overheating, will be followed.",[42],{"type":58,"name":48,"description":62,"armGroupLabels":63,"otherNames":30},"Mothers assigned to this intervention will receive face-to-face training on midline flexion swaddling, supported by an educational brochure and instructional video. The infant will be placed supine, with the upper extremities maintained close to the midline in a flexed position. The hips and knees will remain flexed with sufficient space for free movement of the lower extremities. The swaddle will allow approximately two-finger space at the chest, and the infant's face and head will remain uncovered. Mothers will apply the technique as part of the infant's sleep routine for four weeks. Safe swaddling principles, including avoiding excessive tightness and overheating, will be followed.",[48],[65],{"name":66,"affiliation":67,"role":68},"Bahise Aydın, PhD","İzmir University of Economics","PRINCIPAL_INVESTIGATOR",[70],{"name":66,"role":71,"phone":72,"phoneExt":30,"email":73},"CONTACT","05555210896","bahise.aydin@ieu.edu.tr",[75],{"facility":76,"status":30,"city":77,"state":78,"zip":79,"country":80,"countryCode":30,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Izmir University of Economics Medical Point Hospital","Cordaleo","İzmir","35575","Turkey (Türkiye)",{"type":82,"coordinates":83},"Point",[84,85],27.1142,38.45772,{"lat":85,"lon":84},[88,90],{"name":66,"role":71,"phone":89,"phoneExt":30,"email":73},"+905555210896",{"name":66,"role":68,"phone":30,"phoneExt":30,"email":30},{"type":68,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Bahise Aydın","Associate Professor of Pediatric Nursing",[95],{"name":96,"class":6},"The Scientific and Technological Research Council of Turkey","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":108,"type":109},96,"ESTIMATED","INTERVENTIONAL",[112],"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.",[115],"Infant Sleep and Crying",[117,118,119,17,120,42,48],"Swaddling","Infant Sleep","Infant Crying","Infant Care","NOT_YET_RECRUITING","2026-10-09",{"date":124,"type":125},"2026-10-13","ACTUAL",{"date":127,"type":109},"2026-10",{"date":129,"type":109},"2027-08",{"name":5,"class":6},1]