[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":18,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":18,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":18},{"fullName":5,"class":6},"Aydin Adnan Menderes University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vocal Shooting Group","EXPERIMENTAL","Newborns in this group receive researcher-delivered vocal shooting during nursing care procedures in the NICU.",[13],"Behavioral: vocal soothing",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Newborns in this group will not undergo any intervention by the researcher; routine care procedures will be applied.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","vocal soothing","Prior to the afternoon routine care in the Neonatal Intensive Care Unit, baseline assessments will be completed by the selected clinical nurse using the Neonatal Stress Scale and Neonatal Follow-up Form. During the approximately 10-minute routine care procedure (eye care, oral care, diaper change, probe repositioning, and weight measurement), the investigator will administer a verbal reassurance intervention. The intervention involves speaking to the newborn calmly, reassuringly, and lovingly from a distance of approximately 20 cm, maintaining eye contact and minimizing environmental stimuli. The volume will be kept between 45-60 dB. Outcome measurements will be repeated by the same nurse 5 minutes after the start of care and 5 minutes after the completion of care.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Egenaz G Yaman","CONTACT","+90 533 327 3144","egenaaz12@gmail.com",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Egenaz Gülten Yaman","Master's Student","100644662","effect-of-vocal-soothing-on-stress-in-neonates-during-nursing-care-100644662",false,"NCT07673133","EFFECT OF VOCAL SOOTHING ON STRESS IN NEONATES DURING NURSING CARE","THE EFFECT OF VOCAL SOOTHING DURING NURSING CARE ON INFANT STRESS AND PHYSIOLOGICAL PARAMETERS IN THE NEONATAL INTENSIVE CARE UNIT","Inclusion Criteria:\n\n* Newborns with a gestational age between 32 0\u002F7 and 36 6\u002F7 weeks\n* Newborns with an APGAR score above 6 at 5 minutes\n* Newborns weighing over 1000 grams\n* Newborns not on mechanical ventilation\n* Newborns who have been fed at least one hour prior to care\n* Newborns cared for in an incubator\n* Newborns who have passed the hearing test\n\nExclusion Criteria:\n\n* Presence of a condition that prevents the assessment of stress and physiological parameters (birth trauma, intracranial hemorrhage, congenital anomaly, etc.),\n* Undergoing an invasive procedure that causes different stress at least one hour before the care (intravenous access, aspiration procedure, etc.),\n* Administration of sedatives, opioids, and anticonvulsant drugs before the care.","ALL","0 Days","28 Days",{"count":46,"type":47},72,"ESTIMATED","INTERVENTIONAL",[50],"NA","The aim of this study is to determine the effect of verbal soothing applied by the researcher during routine nursing care in the neonatal intensive care unit on neonatal stress and physiological parameters.\n\nNewborns will be divided into two groups, an intervention group and a control group, using simple randomization. Verbal soothing will be applied to the intervention group during routine nursing care (eye care, oral care, diaper changing, probe placement, weight measurement, body care), while no intervention will be performed on the infants in the control group; only routine care procedures will be applied.",[53],"İnfant Stress",[55,56,57,58,59],"newborn","stress","care","nurse","soothing voice","NOT_YET_RECRUITING","2026-06-23",{"date":63,"type":64},"2026-06-29","ACTUAL",{"date":66,"type":47},"2027-02",{"date":68,"type":47},"2028-01",{"name":5,"class":6}]