[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":12,"centralContacts":29,"locations":12,"responsibleParty":35,"collaborators":12,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":12,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":12,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":68,"whyStopped":12,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":12},{"fullName":5,"class":6},"Uludag University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group (Standard Venipuncture Procedure)","NO_INTERVENTION","Children in the control group will undergo the standard venipuncture procedure, including an explanation of the procedure and the use of reassuring expressions.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention Group (Video Game-Based Breathing Exercise During Venipuncture)","EXPERIMENTAL","Children in the intervention group will receive a video game-based breathing exercise in addition to standard venipuncture. The game, selected from the \"Breathing Games\" application based on the child's age and preferences, will be delivered via the BREATHING+ device with an expiratory-sensitive mouthpiece. Children and parents will be briefly instructed on device use. The child will be guided to inhale through the nose and exhale into the mouthpiece. The exercise will be performed for 1 minute, followed by 2 minutes of rest for procedure preparation, then resumed 1 minute before and continued during venipuncture, totaling approximately 3 minutes.",[18,19],"Other: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture)","Device: Video Game-Based Breathing Exercise Device",[21,24],{"type":6,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"Children in the intervention group will receive a video game-based breathing exercise in addition to standard venipuncture.",[14],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DEVICE","Video Game-Based Breathing Exercise Device","The system consists of a head-mounted headset unit and a mouthpiece sensor that detects expiration. It operates the game through a mouthpiece that senses the child's exhalation via the oral route and does not involve any medication, electrical stimulation, or invasive procedures.",[14],[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Ayşenur AKKAYA GÜL, Assistant Professor","CONTACT","(0216) 910 19 07","aysenurakkaya006@gmail.com",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":39,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Aysenur Akkaya Gul","Assistant Professor","Fenerbahce University","100635236","effect-of-game-based-breathing-exercise-on-pain-fear-and-anxiety-in-children-during-venipuncture-100635236",false,"NCT07550062","Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture","The Effect Of Video Game-Based Breathing Exercise Intervention On Pain, Fear, And Anxiety During Routine Venipuncture In Pediatric Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* • Being between 7-12 years of age\n\n  * Undergoing a venipuncture procedure\n  * Able to understand and speak Turkish\n  * Having written informed consent from the parent\u002Flegal guardian and age-appropriate verbal assent from the child\n\nExclusion Criteria:\n\n* • History of epilepsy or recurrent seizures\n\n  * Presence of severe congenital chronic disease, congenital anomaly, or behavioral disorder\n  * Presence of visual or hearing impairment, or cognitive\u002Fdevelopmental delay\n  * Use of psychoactive medications\n  * Presence of oral, lip, or orofacial anomalies that may interfere with breathing exercises",true,"ALL","7 Years","12 Years",{"count":52,"type":53},60,"ESTIMATED","INTERVENTIONAL",[56],"NA","Venipuncture is one of the most common invasive procedures in children and is often associated with significant pain, fear, and anxiety.This randomized controlled study will aim to evaluate the effects of a video game-based breathing exercise intervention on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture. While the intervention group will receive a video game-based breathing exercise using the BREATHING+ system in addition to standard care, the control group will receive routine venipuncture procedures only. The study population will consist of children aged 7-12 years who meet the inclusion criteria and whose parents\u002Flegal guardians provide informed consent. Participants will be randomly assigned to intervention and control groups. Pain, fear, and anxiety levels will be assessed at three time points: before the procedure, during the procedure, and immediately after the procedure. Data will be collected using the Visual Analog Scale (VAS), Children's Anxiety Scale-State (CAS-S), and Children's Fear Scale (CFS), along with a structured questionnaire form. All assessments will be conducted at the predefined time points.",[59,60,61,62],"Non-Pharmacological Interventions","Breathing Exercise","Venipuncture Pain","Pain Management",[64,65,66,67],"Pediatric venipuncture","Pain management","Breathing exercise","Non-pharmacological intervention","NOT_YET_RECRUITING","2026-04-17",{"date":71,"type":72},"2026-04-24","ACTUAL",{"date":74,"type":53},"2026-05",{"date":76,"type":53},"2027-05",{"name":5,"class":6}]