[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592459":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":63,"collaborators":67,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":31,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Kilis 7 Aralik University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"mother massage group","EXPERIMENTAL","In family health centers, the time and hour of the massage training will be determined with the mothers of infants diagnosed with IC. At this stage, the researcher will provide face-to-face, applied, one-to-one training on massage to the mothers of the babies in the mother group according to the constructivist learning model. Each training will be explained specifically for the mother and her baby. The infant massage will be demonstrated by the researcher on the model, and the mother will be asked to apply it to her baby at the same time.",[13],"Behavioral: Vimala Massage Training for Mothers",{"label":15,"type":10,"description":16,"interventionNames":17},"father massage group","Unlike the mother group, in this group, one-to-one training will be given to the fathers of the babies. Each training will be explained specifically for the father and his baby.",[18],"Behavioral: Vimala Massage Training for Fathers",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","PLACEBO_COMPARATOR","In the control group, only one of the parents, mother or father, who fulfills the inclusion criteria will participate.",[24],"Other: Control Intervention",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Vimala Massage Training for Fathers","Fathers will receive Vimala massage training and apply it regularly to their babies at home.",[15],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Control Intervention","babies in the control group will not receive any intervention",[20],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Vimala Massage Training for Mothers","Mothers will receive Vimala massage training and apply it regularly to their babies at home.",[9],[41],{"name":42,"affiliation":43,"role":44},"Türkan KADİROĞLU, Asst. Prof. Dr.","Ataturk University","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Elif Simay KOÇ, Lecturer","CONTACT","+90348 814 26 66","kocelifsimay@gmail.com",[52],{"facility":53,"status":31,"city":54,"state":54,"zip":55,"country":56,"countryCode":31,"cosmosGeoPoint":57,"geoPoint":62,"contacts":31},"Atatürk Üniversty","Erzurum","25000","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],41.27694,39.90861,{"lat":61,"lon":60},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Elif Simay KOÇ","Lecturer",[68],{"name":43,"class":6},"100592459","vimala-massage-infantile-colic-sleep-and-development-levels-100592459",false,"NCT06993701","Vimala Massage Infantile Colic, Sleep and Development Levels","The Effect of Vimala Massage Applied by Parents on Infantile Colic, Sleep and Development Levels of Infants","VIMCOLSLEEP","Inclusion Criteria:\n\n* Infants born at term (38-42 weeks of gestation)\n* Aged between 1 and 3 months\n* Birth weight between 2500 and 4500 grams\n* No health problems other than infantile colic\n* Growth and development percentile consistent with current age\n* Diagnosed with infantile colic according to Rome IV criteria\n* Not yet started any treatment for infantile colic\n* No presence of diarrhea or constipation\n* Parents with at least primary school education\n* Able to speak and write in Turkish\n* Provided written and verbal informed consent\n* Volunteered to participate in the study\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Infants and parents who do not meet the inclusion criteria\n* Infants with acute or chronic medical conditions (e.g., congenital anomalies, metabolic disorders)\n* Infants currently receiving any pharmacological or complementary treatment for infantile colic\n* Parents with communication difficulties or cognitive impairments that hinder comprehension of study procedures\n* Parents who have previously participated in a similar infant massage or infantile colic intervention study\n* Parents who are unable or unwilling to complete follow-up assessments or study procedures",true,"ALL","1 Month","3 Months",{"count":82,"type":83},72,"ESTIMATED","INTERVENTIONAL",[86],"NA","Objective: The effect of Vimala massage applied by parents on infantile colic, sleep and developmental levels of infants will be investigated.\n\nMethod: The data of the randomised controlled study is planned to be conducted in 3 Family Health Centres in Kilis province between 01 Jun 2025-01 January 2026. The population of the study will consist of infants diagnosed with IC who come to the FHC centre for diagnosis, treatment or follow-up between the specified dates and meet the inclusion criteria.",[89],"Massage Effect",[91,92,93,94],"vimala massage","infantile colic","sleep","developmental levels","NOT_YET_RECRUITING","2025-05-25",{"date":98,"type":99},"2025-05-29","ACTUAL",{"date":101,"type":83},"2025-06-01",{"date":103,"type":83},"2026-01-01",{"name":5,"class":6},1]