[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659193":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":30,"interventions":40,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":74,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":20,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":20,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":110,"whyStopped":20,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Gazi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"State Anxiety Scale for Children","The State Anxiety Scale for Children was developed by Spielberger et al. in 1970.\n\nThis scale was developed to assess children's momentary emotional states. Its validity in Turkish was established by Öner and Le Compte in 1985. It was translated into Turkish by Özusta (1995).\n\nThe response fields can be extended as needed. The scale consists of 20 items and is designed to assess emotions related to state anxiety. The highest possible score on the scale is 80, and the lowest is 20. A high score indicates a high level of anxiety. The scale's Cronbach's alpha coefficient is 0.89 (Spielberger and Edwards, 1973); in the Turkish version, it is 0.82 (Özusta, 1995).","Change relative to the baseline value on day 5",[14,17],{"measure":15,"description":16,"timeFrame":12},"Child and Adolescent Mindfulness Scale","The scale was developed by Greco et al. (2011), and a study on its validity and reliability in Turkish was conducted by Bilaç et al. (2024). Used to measure mindfulness in children and adolescents aged nine and older, the scale consists of 10 items and is a five-point Likert-type self-report scale (4: always, 3: often, 2: sometimes, 1: rarely, 0: never). The items on the scale are first reverse-coded by changing 0 to 4, 1 to 3, 3 to 1, and 4 to 0 (leaving 2 unchanged), and the total score is calculated by summing all items. Higher scores are considered to indicate a higher level of mindfulness (Bilaç et al., 2024). The scale does not include subscales or cutoff scores. In the original study of the scale, the total Cronbach's alpha coefficient was 0.80 (Greco et al., 2011); in the Turkish adaptation study (Bilaç et al., 2024), it was found to be 0.76.",{"measure":18,"description":19,"timeFrame":12},"Emotional Regulation Scale for Children and Adolescents","Developed by Gullone and Taffe (2012) as an adaptation for children and adolescents of the Emotional Regulation Scale developed by Gross and John (2003). The Turkish adaptation of the scale was conducted by Tetik and Önder (2021). There are no reverse-scored items on the scale.\n\nItems 1, 3, 5, 7, 8, and 10 represent the reappraisal subscale; items 2, 4, 6, and 9 represent the suppression subscale. High scores on the subscales indicate that the emotion regulation strategy represented by that subscale is frequently used (Tetik and Önder, 2021). In the original version of the scale (Gullone and Taffe, 2012), the Cronbach's alpha internal consistency coefficient ranged from 0.82 to 0.86 for the reappraisal subscale and from 0.69 to 0.79 for the suppression subscale. In the Turkish adaptation study, the Cronbach's alpha internal consistency coefficient was found to be 0.79 for the reappraisal subscale and 0.53 for the suppress",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":26,"maskingDescription":20,"whoMasked":27},"DOUBLE",[28,29],"PARTICIPANT","INVESTIGATOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Experimental","EXPERIMENTAL","9-14 years children",[36],"Behavioral: Emotion Diary Administration",{"label":38,"type":39,"description":34,"interventionNames":20},"No Intervention","NO_INTERVENTION",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":20},"BEHAVIORAL","Emotion Diary Administration","Emotion Diary Administration Protocol The emotion diary to be administered to children in the experimental group will be a structured material developed by the researchers. The emotion diary will be administered to children aged 9-14 who are hospitalized in the pediatric intensive care unit, are conscious, able to communicate, and meet the inclusion criteria for the study, for a period of 5 days, for approximately 30 minutes each day. All sessions will be conducted by the researchers; the journal will be completed by the child themselves. The emotion journal is structured to help children become aware of the experiences they go through during their time in intensive care, the emotions they feel, and how these emotions manifest in their bodies and behaviors, and to assist them in developing appropriate coping strategies. The journal will include sections appropriate for the children's age level, such as selecting emotions, naming emotions, written expression, short-answer questions, dr",[32],[47],{"name":48,"affiliation":5,"role":49},"Ebru b KILIÇARSLAN, Professor","STUDY_DIRECTOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":20,"email":55},"Özge Z KÖKSAL","CONTACT","+905345109208","koksalozge26@gmail.com",[57],{"facility":58,"status":20,"city":59,"state":60,"zip":61,"country":62,"countryCode":20,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Ankara Bilkent City Hospital","Ankara","ÇANKAYA","06930","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],32.85427,39.91987,{"lat":67,"lon":66},[70],{"name":71,"role":53,"phone":72,"phoneExt":20,"email":73},"CITY HOSPITAL I Üniversiteler Neighborhood, 6000th Avenue No: 9, Bilkent\u002FÇanka","0312 552 60 00","ankarasehir@saglik.gov.tr",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Özge KOKSAL","RESEARCH ASSİSTANT",[79],{"name":80,"class":6},"Ankara City Hospital Bilkent","100659193","emotion-diary-application-100659193",false,"NCT07860190","Emotion Diary Application","The Effect of the Emotion Diary Application on Awareness, Emotion Regulation, and Anxiety Levels in Pediatric Patients","Inclusion Criteria:\n\n* Children aged 9-14 years\n* Those who voluntarily agree to participate in the study\n* Those who are not intubated and are able to communicate\n* Those who are conscious\n* Children admitted to the intensive care unit will be accepted into the study.\n\nExclusion Criteria:\n\n* Those with visual, hearing, or neurological\u002Fmental impairments that hinder communication;\n* Those with cognitive limitations severe enough to prevent them from responding to the scales;\n* Those under sedation;\n* Children whose clinical condition does not permit the 30-minute intervention; and\n* Children and parents who do not wish to participate in the study.\n\nWithdrawal Criteria:\n\n\\- Those unable to participate in the program for more than 2 days of the five-day schedule.",true,"ALL","9 Years","14 Years",{"count":93,"type":94},64,"ESTIMATED","INTERVENTIONAL",[97],"NA","Pediatric patients, hospitalization in a pediatric intensive care unit (PICU) is not merely a situation requiring physical treatment, but also an experience that has significant psychosocial effects. This project was designed to evaluate the effect of a mood journal intervention on anxiety levels, mindfulness, and emotion regulation skills in conscious pediatric patients aged 9-14 years in a pediatric intensive care unit. An emotion journal is a supportive tool that allows children to express the experiences they have during the day, the emotions they feel, and their reactions to these emotions in a structured format. It is anticipated that this practice may help children develop their abilities to recognize, express, and regulate their emotions; it may also reduce their anxiety levels related to the intensive care process. Children admitted to the pediatric intensive care unit who are conscious, able to communicate, and meet the inclusion criteria will be assigned to the intervention and control groups using a randomization method. At the start of the study, both groups will be provided with the Child and Parent Information Form, the Child and Adolescent Mindfulness Scale, the Emotion Regulation Scale for Children and Adolescents, and the State Anxiety Scale for Children will be administered to both groups. The intervention group will participate in an emotion journaling program for 5 days, approximately 30 minutes per day, while the control group will receive routine clinical care. Data will be analyzed using the SPSS 30.0 statistical software; descriptive statistics, normality tests, parametric or non-parametric group comparison tests, and correlation analyses will be performed. As a result of the project, it is expected that the emotion journaling intervention will reduce children's anxiety levels, increase their mindfulness, and support their emotion regulation skills. It is anticipated that the findings will contribute to the development of implementable, low-cost, and child-centered psychosocial care interventions in pediatric intensive care units.",[100,101,102,103],"Emotion Journal","Pediatric Intensive Care","Emotion Regulation","Emotional Awareness",[105,106,107,108,109],"child","pediatric","intensive care","emotion regulation","therapeutic communication","NOT_YET_RECRUITING","2026-10-07",{"date":113,"type":114},"2026-10-13","ACTUAL",{"date":116,"type":94},"2027-01-01",{"date":118,"type":94},"2027-07-01",{"name":5,"class":6},1]