[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654195":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":32,"studyPopulation":21,"armGroups":33,"interventions":49,"overallOfficials":59,"centralContacts":21,"locations":21,"responsibleParty":64,"collaborators":21,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":21,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":21,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":91,"whyStopped":21,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":21},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Anxiety Level","Anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S). The CAM-S is a visual scale designed to assess children's current state anxiety. Higher scores indicate higher levels of anxiety.","At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).",{"measure":14,"description":15,"timeFrame":12},"Fear Level","Fear will be assessed using the Child Fear Scale (CFS), which consists of five facial expressions ranging from 0 (no fear) to 4 (severe fear). Higher scores indicate higher levels of fear.",[17],{"measure":18,"description":19,"timeFrame":20},"Wound Dressing Duration","The total duration of the burn dressing procedure will be measured using a stopwatch. The measurement will begin at the start of the dressing procedure and end when the dressing procedure is completed. Dressing duration will be recorded in minutes.","During the burn dressing procedure",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of three parallel groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Each participant will remain in the assigned group throughout the study, with no crossover between interventions.","SUPPORTIVE_CARE",{"masking":28,"maskingDescription":29,"whoMasked":30},"SINGLE","The outcome assessor will be blinded to group allocation. Randomization and delivery of the interventions will be performed by a separate researcher.",[31],"OUTCOMES_ASSESSOR","Burn dressing procedures can be stressful and anxiety-provoking experiences for children. Repeated exposure to painful dressing procedures may contribute to anticipatory anxiety and fear, which can further complicate the child's experience of burn care. Non-pharmacological interventions may provide a simple and supportive approach to managing these responses alongside routine clinical care.\n\nJaw relaxation is a relaxation technique that does not require sequential contraction and relaxation of multiple muscle groups. The technique involves allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and maintaining a slow breathing rhythm consisting of inhalation, exhalation, and rest. Although jaw relaxation has been investigated in adults with burns, evidence regarding its use in children with burns is lacking. This study adapts the technique for children using a brief video-guided approach.\n\nThis study is designed as a three-arm randomized controlled trial involving children aged 4-10 years receiving inpatient treatment in a pediatric burn unit. A total of 60 children will be assigned to one of three groups: a video-guided jaw relaxation group, a video-guided breathing exercise group, or a control group. Children in the video-guided jaw relaxation group will watch a 5-minute video demonstrating jaw, tongue, and lip relaxation combined with a slow inhale-exhale-rest breathing rhythm and will perform the demonstrated exercises simultaneously. Children in the video-guided breathing exercise group will follow a 5-minute video demonstrating the same slow breathing rhythm without instructions related to relaxation of the jaw, tongue, or lips. The control group will receive routine care without either video-guided intervention.\n\nAnxiety and fear will be assessed at three time points: before the intervention (T1), immediately after the intervention and before burn dressing (T2), and immediately after completion of the dressing procedure (T3). Anxiety will be assessed using the Children's Anxiety Meter-State, and fear will be assessed using the Child Fear Scale. The total duration of the dressing procedure will also be recorded using a stopwatch.\n\nThe study aims to determine and compare the effects of video-guided jaw relaxation and video-guided breathing exercises on anxiety, fear, and dressing duration in children undergoing burn dressing. The findings may provide evidence for a brief, developmentally appropriate, and easily applicable non-pharmacological intervention that can be integrated into pediatric burn care.",[34,38,44],{"label":35,"type":36,"description":37,"interventionNames":21},"Control Group","NO_INTERVENTION","Children assigned to the control group will receive routine care without any video-guided relaxation or breathing intervention. Anxiety and fear will be assessed at the same time points as in the intervention groups: before the dressing procedure (T1), immediately before dressing (T2), and immediately after completion of the dressing procedure (T3). The total duration of the dressing procedure will also be recorded.",{"label":39,"type":40,"description":41,"interventionNames":42},"Video-Guided Breathing Exercise Group","ACTIVE_COMPARATOR","Intervention Description:\n\nChildren assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing. The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video. The video will not include any instructions regarding",[43],"Behavioral: Video-Guided Breathing Exercise",{"label":45,"type":40,"description":46,"interventionNames":47},"Video-Guided Jaw Relaxation Group","Children assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing. The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm. Children will be instructed to perform the demonstrated exercises simultaneously while watching the video. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.",[48],"Behavioral: Video-Guided Jaw Relaxation",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":21},"BEHAVIORAL","Video-Guided Jaw Relaxation","1\\. Video-Guided Jaw Relaxation\n\nIntervention Description:\n\nChildren assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing. The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm. Children will be instructed to perform the demonstrated exercises simultaneously while watching the video. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.",[45],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":21},"Video-Guided Breathing Exercise","Children assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing. The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video. The video will not include any instructions regarding relaxation of the jaw, tongue, or lips. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.",[39],[60],{"name":61,"affiliation":62,"role":63},"Esra Ardahan Akgül, PhD","İzmir Katip Çelebi University","STUDY_CHAIR",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","ESRA ARDAHAN AKGUL","Asst. Prof.","100654195","video-guided-jaw-relaxation-and-breathing-exercises-in-children-with-burns-100654195",false,"NCT07796243","Video-Guided Jaw Relaxation and Breathing Exercises in Children With Burns","Effects of Video-Guided Jaw Relaxation and Breathing Exercises on Anxiety, Fear, and Dressing Duration in Children With Burns: A Three-Arm Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 4-10 years\n* Receiving inpatient treatment in the Pediatric Burn Unit\n* Having undergone at least three previous burn dressing procedures\n* Able to communicate in Turkish\n* No visual or hearing impairment that would prevent participation in the video-guided intervention\n* No administration of an anxiolytic medication before the dressing procedure that could affect the study outcomes\n* No burns involving the face or neck\n* Child and parent\u002Flegal guardian willing to participate in the study and provide the required assent\u002Fconsent\n\nExclusion Criteria:\n\n* Child or parent\u002Flegal guardian requesting withdrawal from the study\n* Inability to tolerate or complete the assigned video-guided jaw relaxation or breathing exercise\n* Development of a serious clinical complication or requirement for intensive care during data collection\n* Inability or refusal to comply with the study protocol, including discontinuation or refusal of the assigned intervention","ALL","4 Years","10 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","This randomized controlled trial aims to evaluate the effects of video-guided jaw relaxation and video-guided breathing exercises on anxiety, fear, and dressing duration in children with burns. Children aged 4-10 years receiving inpatient care in a pediatric burn unit will be randomly assigned to one of three groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Children in the intervention groups will perform the assigned exercise simultaneously with a 5-minute video before burn dressing, while children in the control group will receive routine care. Anxiety and fear will be assessed at three time points: before the intervention (T1), immediately after the intervention and before dressing (T2), and immediately after dressing (T3). Dressing duration will also be recorded. The study will determine whether these brief, video-guided non-pharmacological interventions reduce anxiety and fear associated with burn dressing and affect dressing duration in children.",[86],"Burn",[88,89,90],"anxiety","fear","wound dressing","NOT_YET_RECRUITING","2026-09-04",{"date":94,"type":95},"2026-09-08","ACTUAL",{"date":97,"type":80},"2027-06-01",{"date":99,"type":80},"2028-06-01",{"name":5,"class":6}]