[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652765":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":48,"centralContacts":52,"locations":61,"responsibleParty":78,"collaborators":57,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":57,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":57,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":64,"whyStopped":57,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Bandırma Onyedi Eylül University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality Group","EXPERIMENTAL","In the virtual reality application, the researcher introduced the VR BOX goggles to the children before starting the inhaler therapy and allowed a 2 to 3-minute familiarization window. Concurrently with the initiation of the standard nebulization process, an age-appropriate 360-degree panoramic underwater world animation video was started inside the headset. This active distraction phase lasted for the entire duration of the inhalation therapy (approximately 5 to 10 minutes). The child actively explored the digital marine environment via head movements while breathing smoothly. The Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and vital physiological parameters-specifically heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO2)-were continuously monitored, evaluated, and recorded immediately before starting the therapy (baseline pre-test) and immediately after the final mask removal (post-test).",[13],"Device: Virtual Reality Goggles (VR BOX)",{"label":15,"type":10,"description":16,"interventionNames":17},"Distraction Cards Group","In the distraction cards group, the researcher introduced the laminated interactive Pain Care Labs DistrACTION® Cards to the children before inhaler therapy. At the start of nebulization, the cards were presented at the child's eye level and used throughout the 5-10-minute inhalation period. The researcher maintained the child's attention through age-appropriate riddles, character identification, and search-and-find activities on the cards. The Children's Fear Scale (CFS), Children's Anxiety Scale-State (CAS-S), and physiological parameters, including heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO₂), were assessed immediately before therapy and after mask removal.",[18],"Behavioral: Interactive Distraction Cards (DistrACTION® Cards)",{"label":20,"type":6,"description":21,"interventionNames":22},"Control Group","In the control group, pediatric patients received the physician-prescribed standard emergency nebulization therapy administered by the unit clinical staff according to routine hospital protocols, entirely devoid of any supplementary non-pharmacological distraction materials, technology, interactive play cards, or games during the therapy. Children underwent the inhalation procedure accompanied by their parents. The Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), and vital physiological parameters-specifically heart rate (HR), respiratory rate (RR), and peripheral oxygen saturation (SpO2)-were evaluated, measured, and recorded at identical timelines, immediately before starting the therapy (baseline pre-test) and immediately after the final mask removal (post-test).",[23],"Other: Standard Clinical Care",[25,34,41],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Virtual Reality Goggles (VR BOX)","Active cognitive distraction using a calibrated VR BOX headset equipped with 42mm aspheric optical resin lenses tailored to the child's interpupillary distance. Concurrently with standard medical nebulization, children watch an open-access 360-degree panoramic underwater world animation simulation video on a secure smartphone. The adjustable head strap allows concurrent mask placement. Duration matches the complete medical inhalation cycle (5-10 minutes), delivered in a single session. Clinical fear (CFS), state anxiety (CAS-S), and autonomically-driven physiology-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are explicitly recorded at standardized pre-test (baseline) and post-test timelines immediately surrounding mask removal.",[9],[31,32,33],"VR BOX","Virtual Reality Headset","3D VR Glasses",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Interactive Distraction Cards (DistrACTION® Cards)","Interactive cognitive distraction using the patent-protected, liquid-impermeable laminated Pain Care Labs DistrACTION® Cards set held at the patient's exact eye level. Concurrently with standard emergency nebulization, the primary researcher verbally guides the child through structured, multi-layered visual illustrations and age-specific tasks (riddles, counting, find-and-search missions) printed on the reverse side to systematically capture working memory. Distraction lasts the entire inhalation cycle (5-10 minutes) in a single session. Clinical fear (CFS), state anxiety (CAS-S), and autonomically-driven physiology-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are recorded at identical pre-test and post-test timelines.",[15],[40],"Pain Care Labs Distraction Cards",{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Standard Clinical Care","Standard liquid aerosol emergency medical nebulization therapy administered by the unit clinical nursing staff according to routine hospital department guidelines and physician orders. The non-invasive mask delivery procedure is conducted entirely devoid of any supplementary non-pharmacological distraction materials, interactive cards, play-based therapies, or technological instruments, while maintaining regular parental presence at the bedside. To ensure comparative control, clinical fear (CFS), state anxiety (CAS-S), and physiological vital signs-specifically heart rate (HR), manual 60-second respiratory rate (RR), and oxygen saturation (SpO2)-are tracked at identical timelines.",[20],[46,47],"Routine Nebulization Therapy","Standard Hospital Care",[49],{"name":50,"affiliation":5,"role":51},"Diler Yılmaz, Prof. Dr.","STUDY_CHAIR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Ecem Bakış, BSc, RN","CONTACT","+90 5459355068",null,"bakisecem0@gmail.com",{"name":50,"role":55,"phone":57,"phoneExt":57,"email":60},"daydin@bandirma.edu.tr",[62],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":67,"countryCode":57,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Susurluk State Hospital, Emergency Department","RECRUITING","Balıkesir","10600","Turkey (Türkiye)",{"type":69,"coordinates":70},"Point",[71,72],27.88611,39.64917,{"lat":72,"lon":71},[75,77],{"name":54,"role":55,"phone":76,"phoneExt":57,"email":58},"+90 545 935 50 68",{"name":50,"role":55,"phone":57,"phoneExt":57,"email":60},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Ecem Bakış","Graduate Student \u002F Master's Candidate, Department of Pediatric Nursing","100652765","the-effect-of-using-virtual-reality-glasses-and-gaming-cards-on-fear-anxiety-and-physiological-parameters-in-children-administered-inhaler-medication-100652765",false,"NCT07780331","The Effect of Using Virtual Reality Glasses and Gaming Cards on Fear, Anxiety, and Physiological Parameters in Children Administered Inhaler Medication","Inclusion Criteria:\n\n* Child being between the ages of 4 and 6 years.\n* Parents and children being completely voluntary to participate in the study.\n* Child having no visual, auditory, or cognitive communication barriers.\n* Child's cognitive level and motor development being appropriate for their age.\n* Child having no life-threatening acute or chronic systemic disease.\n* Child having no mental or neurological disability or condition.\n* Child and parent being fully open to effective communication and clinical cooperation.\n* Child having no medical condition that prevents inhaler mask or nebulizer application.\n\nExclusion Criteria:\n\n* Child having any acute clinical condition that mechanically prevents inhaler treatment.\n* Child having a severe, life-threatening acute or chronic health problem at presentation.\n* Sudden development of severe clinical instability preventing completion of the trial.",true,"ALL","4 Years","6 Years",{"count":93,"type":94},150,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study aims to evaluate the effects of using virtual reality headsets and play cards during the administration of inhaler medication in pediatric patients. The primary goal is to determine how these distraction methods influence children's fear, anxiety levels, and physiological parameters (such as heart rate and oxygen saturation). The study population consists of pediatric patients aged between 4 and 6 years. Data collection for the targeted sample size of 150 children commenced in September, and the recruitment process is currently ongoing.Children receiving inhaler treatments often experience fear and anxiety, which can negatively affect their treatment compliance and vital signs. In this study, participants are divided into different groups to compare the effectiveness of virtual reality headsets and traditional play cards as distraction tools.",[100,101,102,103],"Respiratory Tract Diseases","Pediatric Disorders","Anxiety","Fear",[105,106,107,108,103,109,110],"Virtual Reality","Distraction Techniques","Inhalation Therapy","Procedural Anxiety","Pediatric Nursing","Randomized Controlled Trial","2026-08-19",{"date":113,"type":114},"2026-08-21","ACTUAL",{"date":116,"type":114},"2025-09-28",{"date":118,"type":94},"2026-10",{"name":5,"class":6},1]