[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522697":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":42,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":25,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Dalarna University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Infant directed singing","EXPERIMENTAL","The intervention group will receive standard breastfeeding support from health care staff combined with maternal infant-directed singing during breastfeeding. The starting point of the singing will be individually assessed and tailored to the dyads and will start approximately a few minutes before breastfeeding starts. An educational video about how to apply infant-directed singing will be shown to all mothers in the intervention group.",[13],"Behavioral: Infant directed singing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Mothers allocated to the control group will be offered standard breastfeeding support from health care staff, and data on secondary outcome measures will be collected during one breastfeeding session.",[19],"Behavioral: Standard care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","In every known human culture and historical period, infant-directed singing exists as a natural feature of parental care for newborn infants. Infant-directed singing is effective in regulating infant affect and in capturing an infant's attention for a longer period than infant-directed speech. Parental stress significantly decreases when parents are encouraged to use their own voices to soothe their infants with a song or a lullaby of their choice.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard breastfeeding support to mothers with breastfeeding difficulties provided by health care professionals.",[15],[30],{"name":31,"affiliation":5,"role":32},"Jenny Ericson, Docent","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Jenny Ericson, PhD","CONTACT","+46707883532","jeer@du.se",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Alexandra Ullsten, PhD","alexandra.ullsten@regionvarmland.se",{"type":32,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jenny Ericson","Associated Professor","100522697","nynnamm---effects-of-infant-directed-singing-on-breastfeeding-difficulties-100522697",false,"NCT06085989","Nynnamm - Effects of Infant Directed Singing on Breastfeeding Difficulties","Nynnamm","Inclusion Criteria:\n\n* Mothers who seek support for breastfeeding difficulties.\n* Mothers who seek support for experiencing a low milk supply.\n* Mothers who seek support for sore nipples.\n* Mothers who seek support for breast pain.\n* Mothers who seek support for feeling stressed.\n* Mothers who seek support for feeling unwell while breastfeeding.\n* Mothers who seek support for having an infant who has problems with latching the breast.\n* Must understand Swedish or English.\n* Must be over 18 years old.\n\nExclusion Criteria:\n\n* Living outside Region Dalarna, Sweden\n* Living outside Region Uppsala, Sweden\n* Living outside Region Värmland, Sweden",true,"FEMALE","18 Years",{"count":56,"type":57},260,"ESTIMATED","INTERVENTIONAL",[60],"NA","Breastfeeding is one of the most effective, health economical interventions to promote health and reduce illness in both mothers and children. However, breastfeeding in Sweden is under threat. An increasing number of newborns will miss out on its benefits because lack of lactation support for mothers with breastfeeding difficulties, which is the main reasons for breastfeeding cessation. About 110,000 mothers breastfeed every year but the prevalence is decreasing. Many mothers are dissatisfied with the support they receive from health care. Maternal infant-directed singing could be an effective, person- and family-centered, cost-effective, self-care intervention to reduce stress and breastfeeding difficulties in new mothers as well as increasing oxytocin, which is an important hormone for lactation and well-being.\n\nThis project evaluates the effect of a self-care intervention involving maternal infant-directed singing during breastfeeding on maternal stress, experiences, and breastfeeding rates up to six months postpartum among mothers with breastfeeding difficulties. The mothers are randomized to standard care and infant-directed singing or control with standard care. The primary outcome is the proportion of breastfeeding four weeks after the intervention. 260 mothers will be included in the project, which will be conducted during 2024-2025, and data will be analyzed and presented in 2026. A data management plan will ensure that all research activities are well organized.",[63],"Breastfeeding","NOT_YET_RECRUITING","2023-10-10",{"date":67,"type":68},"2023-10-17","ACTUAL",{"date":70,"type":57},"2024-01-01",{"date":72,"type":57},"2028-12-31",{"name":5,"class":6}]