[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652441":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":11,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Bilecik Seyh Edebali Universitesi","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The Effect of Maternal Voice and Music Therapy on Pain and Stress","EXPERIMENTAL","The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns",[13,14],"Other: Music Therapy","Other: Maternal Voice",[16,21],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Music Therapy","In the group where Music Therapy will be applied, the heel prick blood test procedure and the study will be explained to the newborn and their parents. After obtaining consent, music therapy will be applied to the newborn 5 minutes before, during, and after the procedure. During this time, data will be recorded on a form by the observer. The song \"The Happiest Child,\" developed by Fulya Merve KOS, a researcher with a Rhythm Therapist™ certificate issued by the Ministry of National Education, will be used in music therapy. The sound will be adjusted to 45 dB. The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from their ear, five minutes before the procedure and played to the child during the procedure. This sound will be played to the child 5 minutes before, during, and 5 minutes after the heel prick blood test, and data will be recorded by two observers and evaluated using the Newborn Infant Pain Scale (NIPS) and the Newborn Stress Scale.",[9],null,{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Maternal Voice","In the group where the mother's voice will be used, the child's parents will be informed that the mother's voice will be used for pain relief in the study. For each newborn whose heel prick blood sample is taken by the researcher, the mother's voice will be recorded using a voice recorder. To play the mother's voice, the voice recorder will be placed 50 cm away from the child and the measurement will be taken. The sound level of the mother's voice will be set to an average of 45 decibels. The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from the ear, five minutes before the procedure and will be played to the child during the procedure. The child will be played this voice 5 minutes before, during, and 5 minutes after the heel prick blood sample is taken. Data will be recorded by two observers and evaluated using the Neonatal Infant Pain Scale (NIPS) and the Neonatal Stress Scale.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Fulya Merve FMK KOS, Assis Prof Dr","CONTACT","05300974816","fulya.kos@bilecik.edu.tr",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":20,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Bilecik Seyh Edebali University","Bilecik","Turkey","11230","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],29.97932,40.14192,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":29,"phoneExt":20,"email":30},"Fulya KOS",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Fulya Kos","Assis Prof Dr","100652441","the-effect-of-maternal-voice-and-music-therapy-on-pain-and-stress-during-heel-prick-testing-in-newborns-100652441",false,"NCT07773792","The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Newborns within the first 24-48 hours after birth or 7-14 days old\n* At least 2 hours after the last painful intervention\n* Children whose parents agreed to participate in the study were included.\n\nExclusion Criteria:\n\n* Presence of hearing impairment\n* Absence of Parental Consent Form",true,"ALL","0 Days","40 Days",{"count":62,"type":63},80,"ESTIMATED","INTERVENTIONAL",[66],"NA","During the adaptation process to the extrauterine environment, healthy newborns face procedures such as hepatitis B vaccination, vitamin K injection, blood sugar monitoring, bilirubin or metabolic disease screening. Heel prick blood sampling, performed for diagnostic purposes, is one of the most frequently performed procedures on newborns. Studies show that heel prick blood sampling holds an important place among invasive procedures performed on newborns. The heel prick blood sampling procedure, frequently performed on newborns, is... It has been reported that pain perception causes stress, and consequently, an increase in heart rate (HR) and blood pressure, a decrease in oxygen saturation (SpO2), and crying Following routine invasive procedures that cause pain, such as heel prick blood tests, children may experience negative physiological, metabolic, and behavioral responses as stress, duration, and intensity of pain increase. Increases in heart rate, respiratory rate, and blood pressure are observed due to the release of catecholamines, glucagon, and steroids following painful stimuli, and these physiological changes observed in response to pain are thought to play a role in initiating ischemic changes by leading to intraventricular hemorrhage and white matter damage around the ventricle. If pain is not effectively relieved or eliminated during this period, it can lead to neurological and behavioral disorders in later stages. Excessive and prolonged pain, particularly that resulting from invasive procedures, causes behavioral stress and physiological imbalances. It is believed that any painful invasive procedure can hinder a child's behavior, feeding habits, interaction with the mother, and adaptation to the environment. Furthermore, experiencing pain can influence subsequent pain behaviors, leading to a lifelong sensitivity to pain in the child. To reduce the effects of invasive procedures on newborns, effective pain management is divided into two categories: pharmacological and non-pharmacological. Non-pharmacological pain management strategies in children are defined as any strategy or technique applied to a child in pain to reduce their experience of pain. Recorded maternal voice and maternal heartbeat listening, music therapy are some of the non-pharmacological methods used in children. Music therapy is noted as one of the non-pharmacological methods widely used in postoperative analgesia, possessing effects such as increasing endorphin release, reducing catecholamine levels and thus decreasing the need for analgesics, stabilizing heart rhythm and respiratory rate, maintaining hemodynamic balance, influencing regional cardiac activity, and lowering blood pressure.",[69,22,17,70],"Newborn","Heel Prick Testing",[72,70,73,74],"newborn","maternal voice","music therapy","NOT_YET_RECRUITING","2026-08-16",{"date":78,"type":79},"2026-08-19","ACTUAL",{"date":81,"type":63},"2026-07-29",{"date":83,"type":63},"2026-09-01",{"name":5,"class":6},1]