[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656840":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":39,"studyPopulation":27,"armGroups":40,"interventions":51,"overallOfficials":27,"centralContacts":57,"locations":63,"responsibleParty":77,"collaborators":27,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":27,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":27,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":108,"whyStopped":27,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Gazi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"State Anxiety","State anxiety will be assessed using the State Anxiety Inventory for Children. Higher scores indicate greater levels of state anxiety. Assessments will be performed immediately before and immediately after the interventio","Immediately before the intervention and immediately after the intervention (approximately 10 minutes).",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Heart Rate","Heart rate will be measured in beats per minute using the standard clinical monitoring device. Measurements will be obtained immediately before and immediately after the intervention.","Immediately before and immediately after the intervention, approximately 10 minutes apart.",{"measure":19,"description":20,"timeFrame":17},"Blood Pressure","Systolic and diastolic blood pressure will be measured in millimeters of mercury using a calibrated clinical blood pressure monitor. Measurements will be obtained immediately before and immediately after the intervention",{"measure":22,"description":23,"timeFrame":17},"Respiratory Rate","Respiratory rate will be measured as breaths per minute immediately before and immediately after the intervention.",{"measure":25,"description":26,"timeFrame":17},"Peripheral Oxygen Saturation","Peripheral oxygen saturation will be measured as a percentage using pulse oximetry immediately before and immediately after the intervention.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either a virtual reality-based guided breathing exercise group or a standard care control group. The intervention will be administered once before angiography, and outcomes will be assessed before and immediately after the intervention.","SUPPORTIVE_CARE",{"masking":34,"maskingDescription":35,"whoMasked":36},"DOUBLE","Participants and outcome assessors will be blinded to group allocation. Participants will not be informed whether they are assigned to the intervention or control group. Outcome assessments will be performed by assessors who are unaware of participants' group assignments. Group allocation codes will remain concealed until completion of data analysis to minimize assessment bias.",[37,38],"PARTICIPANT","OUTCOMES_ASSESSOR","Children undergoing angiography frequently experience anxiety before the procedure because of unfamiliar hospital environments, uncertainty about the procedure, and fear of invasive interventions. Increased pre-procedural anxiety may negatively affect physiological parameters, procedural cooperation, and the overall treatment experience. Therefore, effective and safe non-pharmacological interventions are needed to improve children's psychological well-being before angiography.\n\nVirtual reality (VR) has emerged as an effective non-pharmacological intervention for reducing anxiety by providing immersive distraction and promoting relaxation. Combining VR with guided breathing exercises may further enhance relaxation through activation of the parasympathetic nervous system and improvement of emotional regulation. Although VR and breathing exercises have separately demonstrated beneficial effects in pediatric populations, evidence regarding their combined use before pediatric angiography remains limited.\n\nThe aim of this randomized controlled trial is to evaluate the effect of a VR-based guided breathing exercise administered before angiography on anxiety and physiological parameters in children aged 9 to 18 years undergoing elective angiography.\n\nA total of 60 participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a single session of an approximately 7-8-minute VR-based guided breathing exercise before angiography in addition to standard care. Participants in the control group will receive standard pre-procedural care alone.\n\nThe primary outcome will be state anxiety. Secondary outcomes will include heart rate, blood pressure, respiratory rate, oxygen saturation, body temperature, and self-reported relaxation\u002Fsatisfaction. Outcomes will be assessed immediately before and immediately after the intervention.\n\nThe findings of this study are expected to provide evidence regarding the effectiveness of VR-based guided breathing exercises as a safe, feasible, and non-pharmacological nursing intervention for reducing anxiety and improving physiological responses in children undergoing angiography.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"experimental","EXPERIMENTAL","Participants assigned to the experimental group will receive a single session of a virtual reality-based guided breathing exercise lasting approximately 7-8 minutes before angiography in addition to routine pre-procedural nursing care. The intervention consists of an immersive, nature-based virtual reality experience combined with guided slow-breathing instructions.",[46],"Behavioral: Virtual Reality-Based Guided Breathing Exercise",{"label":48,"type":49,"description":50,"interventionNames":27},"standart care","NO_INTERVENTION","Participants assigned to the control group will receive routine pre-procedural nursing care before angiography according to the hospital's standard clinical practice. No virtual reality-based guided breathing exercise will be provided.",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":27},"BEHAVIORAL","Virtual Reality-Based Guided Breathing Exercise","A single 5-7-minute virtual reality-based guided breathing exercise delivered before angiography. Participants will wear a virtual reality headset displaying immersive natural scenery while following standardized breathing instructions designed to promote relaxation and reduce pre-procedural anxiety.",[42],[58],{"name":59,"role":60,"phone":61,"phoneExt":27,"email":62},"Çiğdem SARI ÖZTÜRK, PhD","CONTACT","+90 312 216 26 63","cigdemsari@gazi.edu.tr",[64],{"facility":65,"status":27,"city":66,"state":66,"zip":67,"country":68,"countryCode":27,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Ankara Bilkent City Hospital","Ankara","06500","Turkey (Türkiye)",{"type":70,"coordinates":71},"Point",[72,73],32.85427,39.91987,{"lat":73,"lon":72},[76],{"name":27,"role":60,"phone":27,"phoneExt":27,"email":62},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Çiğdem Sarı Öztürk","Associate Professor","100656840","virtual-reality-based-breathing-exercise-before-angiography-in-children-100656840",false,"NCT07830420","Virtual Reality-Based Breathing Exercise Before Angiography in Children","Effect of Virtual Reality-Based Guided Breathing Exercise Before Angiography on Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial","Inclusion Criteria Children aged 9 to 18 years. Diagnosed with congenital heart disease. Scheduled to undergo elective angiography. Able to understand and communicate in Turkish. Participant and parent\u002Flegal guardian willing to provide written informed assent and consent.\n\nClinically stable and able to participate in a virtual reality-based guided breathing exercise.\n\nExclusion Criteria Undergoing emergency angiography. Visual, hearing, cognitive, or neurological impairments that would interfere with participation in the virtual reality intervention or completion of study assessments.\n\nUse of sedative, anxiolytic, hypnotic, or opioid medications before the intervention.\n\nInability to tolerate the virtual reality headset or development of significant cybersickness during the intervention.\n\nWithdrawal of assent or parental\u002Flegal guardian consent.","ALL","9 Years","18 Years",{"count":92,"type":93},60,"ESTIMATED","INTERVENTIONAL",[96],"NA","hildren undergoing angiography frequently experience anxiety before the procedure, which may negatively affect physiological parameters and procedural cooperation. Although pharmacological approaches are commonly used to reduce anxiety, they may be associated with adverse effects and are not always necessary. Virtual reality (VR)-based guided breathing exercises offer a non-pharmacological approach that combines immersive distraction with breathing techniques to promote relaxation.\n\nThis randomized controlled trial aims to evaluate the effect of a VR-based guided breathing exercise administered before angiography on anxiety and physiological parameters in children aged 9-18 years. A total of 60 participants will be randomly assigned to either a VR-based guided breathing exercise group or a standard care group. Anxiety and physiological parameters, including heart rate, blood pressure, respiratory rate, oxygen saturation, and body temperature, will be assessed before and after the intervention. The findings of this study may provide evidence for the use of VR-based guided breathing exercises as a safe and effective nursing intervention to reduce pre-procedural anxiety in pediatric patients.",[99,100],"Anxiety","Angiocardiography",[102,103,104,105,106,107],"children","adolescent","angiography","Virtual Reality","Breathing Exercise","Physiological Parameters","NOT_YET_RECRUITING","2026-09-15",{"date":111,"type":112},"2026-09-21","ACTUAL",{"date":114,"type":93},"2026-09-30",{"date":116,"type":93},"2027-09-01",{"name":5,"class":6},1]