[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619754":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":51,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Atlas University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Buzzy","EXPERIMENTAL","Vibration Application with Buzzy® Before Heel Lance",[13],"Behavioral: Foot bath",{"label":15,"type":10,"description":16,"interventionNames":17},"Shotblocker","After the information form is completed with the parent, the video recording will be initiated. The infant's vital signs will be monitored and recorded using a pulse probe, after which the ShotBlocker® will be placed on the procedure site. Following the heel lance performed with the ShotBlocker®, the time to bleeding cessation and the infant's crying duration will be recorded.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Foot bath","The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.\n\nThe heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.\n\nThe video recording will be stopped once bleeding has ceased at the end of the procedure.\n\nThe video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"sermin dinç, Dr.","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Sermin Dinc, Dr.","CONTACT","5424033430","+90","sermin.dinc@atlas.edu.tr",{"name":27,"role":32,"phone":33,"phoneExt":34,"email":37},"sermindnc@gmail.com",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":24,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"RECRUITING","Istanbul","Kağıthane","34098","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],28.94966,41.01384,{"lat":49,"lon":48},{"type":28,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Sermin Dinc","Assistant Professor","100619754","non-pharmacological-methods-in-heel-lance-100619754",false,"NCT07348731","Non-Pharmacological Methods in Heel Lance","Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance","Inclusion Criteria:\n\n* Newborns with a gestational age of ≥37 weeks\n* Newborns in the neonatal period (0-28 days)\n* Stable vital signs\n* Obtained informed consent from the parents\n* No use of analgesics or sedatives within the 24 hours before the procedure\n* Absence of any respiratory problems\n* First-time heel lance procedure\n* No condition that would interfere with pain assessment\n\nExclusion Criteria:\n\n* Preterm or low birth weight infants (\\\u003C 2500 g)\n* Infants with congenital anomalies or requiring respiratory support\n* Infants receiving sedative or analgesic treatment",true,"ALL","4 Days","1 Month",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"NA","This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.\n\nData will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.",[73],"Heel Lance Procedures",[75,9,15,76],"Foot Bath","heel lance","2026-05-31",{"date":79,"type":80},"2026-06-02","ACTUAL",{"date":82,"type":80},"2026-02-25",{"date":84,"type":67},"2026-06-15",{"name":5,"class":6},1]