[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622082":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":23,"responsibleParty":41,"collaborators":18,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":18,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":18,"overallStatus":26,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"therapeutic play","EXPERIMENTAL","Children in the intervention group will be introduced to therapeutic toy dolls and will be educated on what to do with them. Prior to the training, children will be informed about the importance of intramuscular injections and how they are administered. The reasons for the injection and how it is administered will be explained in detail.\n\nParticipants will be shown the steps involved in intramuscular injection. Using a toy doll, the steps of intramuscular injection will be demonstrated step by step, and the children will practise applying these steps. During the training, children will be told in detail how to administer injections carefully, where the injection should be given, and how to perform the injection correctly. At the end of the training, children will successfully perform the intramuscular injection procedure. The injection will then be administered to the children by the same nurse who received training from the research team.",[13],"Behavioral: therapeutic play",{"label":15,"type":16,"description":17,"interventionNames":18},"control","NO_INTERVENTION","Children in the control group will receive the IM injection at the clinic using routine practice methods.The injection will be administered by the same nurse trained by the research team.",null,[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":18},"BEHAVIORAL",[9],[24],{"facility":25,"status":26,"city":27,"state":18,"zip":18,"country":28,"countryCode":18,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Ataturk University Nursing of Faculty","RECRUITING","Erzurum","Turkey (Türkiye)",{"type":30,"coordinates":31},"Point",[32,33],41.27694,39.90861,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},"ARZU SARIALIOGLU","CONTACT","04422315795","arzu.celebi@atauni.edu.tr",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","ARZU SARIALİOĞLU","Associate professor","100622082","the-effect-of-therapeutic-play-applied-before-intramuscular-injection-100622082",false,"NCT07378995","The Effect of Therapeutic Play Applied Before Intramuscular Injection","The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children","Inclusion Criteria:\n\n* Children aged 4-6 years,\n* Those who will receive intramuscular injections,\n* Those who have been prescribed Desefin flk 1x1 IM,\n* Children whose parents have given consent will be included in the study.\n\nExclusion Criteria:\n\n* Those experiencing pain,\n* Those with hearing problems and communication barriers,\n* Those with chronic illnesses,\n* Those with mental and physical disabilities,\n* Those who have taken analgesics within the last 6 hours,\n* Children who have previously been hospitalised will not be included in the study.",true,"ALL","4 Years","6 Years",{"count":57,"type":58},80,"ESTIMATED","INTERVENTIONAL",[61],"NA","This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures.\n\nChildren, especially at an early age, show great sensitivity towards medical procedures, and these processes can often cause pain, anxiety and fear. This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity to medical procedures, and these processes can often cause pain, anxiety, and fear. This research aims to discover methods of managing and improving children's responses to medical procedures through therapeutic games.\n\nThis study, to be conducted at the Emergency Department of Atatürk University Research Hospital in Erzurum, will be carried out using a randomised controlled design. Participants will be randomly assigned to intervention and control groups. Children in the intervention group will prepare using the therapeutic toy doll, while children in the control group will receive an intramuscular injection at the clinic using routine application methods.\n\nData collection tools will include the Socio-demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-D), and the Wong-Baker Facial Expression Rating Scale.",[64,65,66],"Child, Only","Fear","Pain","2026-01-23",{"date":69,"type":70},"2026-01-30","ACTUAL",{"date":72,"type":70},"2025-12-30",{"date":74,"type":58},"2027-12-30",{"name":5,"class":6},1]