[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648953":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":91,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tokat Gaziosmanpasa University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"white noise group","EXPERIMENTAL","Participants in this group will be exposed to white noise at a constant intensity of 50-55 dB via noise-canceling headphones for 5 minutes before and during the peripheral intravenous (IV) catheterization procedure.",[13],"Behavioral: white noise",{"label":15,"type":10,"description":16,"interventionNames":17},"Pink Noise Group","Participants in this group will be exposed to pink noise at a constant intensity of 50-55 dB via noise-canceling headphones for 5 minutes before and during the peripheral intravenous (IV) catheterization procedure.",[18],"Behavioral: pink noise",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group","NO_INTERVENTION","Participants in this group will receive standard care during the peripheral intravenous (IV) catheterization procedure. Headphones will be worn, but no sound intervention will be administered.",null,[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","white noise","White noise will be administered at a constant intensity of 50-55 dB using noise-canceling headphones for 5 minutes before and during the peripheral intravenous (IV) catheterization procedure.",[9],[31],"sound-based intervention",{"type":26,"name":33,"description":16,"armGroupLabels":34,"otherNames":23},"pink noise",[15],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":23,"email":40},"Zehra Özsoy Butay","CONTACT","+905443259804","zehraozsy1@icloud.com",{"name":42,"role":38,"phone":43,"phoneExt":23,"email":44},"Birgül Vural","+905308828480","birgül.vural@gop.edu.tr",[46],{"facility":47,"status":23,"city":48,"state":49,"zip":50,"country":51,"countryCode":23,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Tokat Gaziosmanpaşa University Hospital","Tokat Province","Merkez","60100","Turkey (Türkiye)",{"type":53,"coordinates":54},"Point",[55,56],36.55444,40.31389,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":61,"phoneExt":23,"email":62},"Tokat Gaziosmanpaşa University Hospital dr. öğr üyesi birgül vural","03562129500","hastane@gop.edu.tr",{"type":64,"investigatorFullName":37,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100648953","the-effect-of-sound-based-interventions-on-pain-and-anxiety-in-pediatric-patients-100648953",false,"NCT07727109","The Effect of Sound-Based Interventions on Pain and Anxiety in Pediatric Patients","Effects of Non-Pharmacological Auditory Interventions on Pain and Anxiety in Pediatric Patients: A Randomized Controlled Trial Comparing White and Pink Noise","PED-SOUND-PAIN","Inclusion Criteria:\n\n* Children between 7-12 years of age.\n* Scheduled for a peripheral intravenous (IV) catheterization procedure.\n* No know hearing impairment.\n* Parents\u002Flegal guardians willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* History of chronic pain or neurological disorder.\n* Use of any analgesic or sedative medication within 24 hours prior to the procedure.\n* Requiring emergency intervention (emergency catheterization).\n* inability to communicate or understand the procedure.","ALL","6 Years","12 Years",{"count":78,"type":79},150,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is a prospective, three-arm, single-blind, randomized controlled clinical trial designed to evaluate the effectiveness of non-pharmacological sound-based interventions on pain and anxiety in pediatric patients. The study will be conducted at a university hospital with 150 children aged 6-12 years who require peripheral intravenous (IV) catheterization. Participants will be randomly assigned to three groups: a white noise group, a pink noise group, or a control group (standard care). Sound interventions (white or pink noise at 50-55 dB) will be administered via noise-canceling headphones for 5 minutes before and during the IV procedure. The primary outcomes will be pain levels assessed by the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale, and anxiety levels assessed by the Children's Fear and Anxiety Scale (CFAS). The study aims to provide evidence-based, safe, and cost-effective alternatives to pharmacological pain management in pediatric clinical procedures.",[85,86],"Pain (Visceral, Somatic, or Neuropathic)","Anxiety Acute",[88,89,27,33,90],"pediatric pain","anxiety","non-pharmacologiacal ıntervention","NOT_YET_RECRUITING","2026-07-22",{"date":94,"type":95},"2026-07-27","ACTUAL",{"date":97,"type":79},"2026-09-01",{"date":99,"type":79},"2027-01-01",{"name":5,"class":6},1]