[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595417":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":22,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":22,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":22,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":85,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fenerbahce University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Guided Imagery","EXPERIMENTAL","To implement the guided imagery method, a text titled \"A Walk in the Forest\" will be used. The text includes descriptions of living and non-living elements in the forest to help the child imagine taking a walk in a forest. It is designed to engage the child's physical senses through sensory language, encouraging a vivid mental experience.One minute before the blood collection procedure, the child will be given headphones and the audio recording will be started.\n\nThe prepared text was recorded in a studio with the support of a professional audio recording specialist. The narration was performed by a professional voice actor specializing in voice work, who read the text in a calm and gentle tone. In the background, soft and slow-paced music was played, and nature sound effects-such as bird chirping, rustling leaves, and flowing water-were added at various points to match the flow of the text. The total duration of the audio recording is 2 minutes and 35 seconds.",[13],"Procedure: Virtual reality, guided imagery",{"label":15,"type":10,"description":16,"interventionNames":17},"Virtual Reality","Virtual reality (VR) glasses will be used in this study. A video or game compatible with a mobile phone will be loaded onto the device, placed in the front compartment of the VR glasses, and the cover will be closed. The glasses will then be positioned on the child's head. When selecting the VR glasses, attention will be given to choosing lightweight and child-friendly models.\n\nIn the Virtual Reality Glasses group, unlike the Guided Imagery group, the child will wear VR glasses and watch a video titled \"A Walk in the Forest\", which was created using artificial intelligence.One minute before the blood collection procedure, the child will be start.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control","NO_INTERVENTION","For the children in the control group, only a routine blood collection procedure will be performed, and they will receive only a standard explanation related to the procedure.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"PROCEDURE","Virtual reality, guided imagery","Before the procedure, children will be informed via the Child Consent Form, and parents through the Informed Consent Form. Verbal and written consents will be obtained, and data will be recorded in the Child Patient Introductory Information Form. Pre-procedural pain will be assessed using the Faces Pain Scale-Revised scale, and the child will mark their pain. Parents will use the VAS scale for pain assessment. The CFS scale will be explained to both the child and parent to assess the child's fear. A pulse oximeter will measure SPO2 and pulse one minute before the procedure.\n\nThe blood collection procedure will be performed by an experienced nurse, and heart rate and oxygen saturation will be recorded in the Application Record Form.\n\nAfter the procedure, measurements will be taken immediately after the procedure and one minute later.\n\nChildren will mark their pain and fear levels on the FPS-R and CFS scales. Parents and observers will also assess the child's pain (VAS) and fear (CFS).",[9,15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":22,"email":34},"Duygu Gözen, Professor","CONTACT","+905327065065","duygugozen@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":22,"email":38},"NEGARIN AKBARI","+905352679510","negarin.akbari@fbu.edu.tr",[40],{"facility":41,"status":22,"city":42,"state":43,"zip":44,"country":45,"countryCode":22,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Koc University","Istanbul","Zeytinburnu","0090","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],28.94966,41.01384,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":37,"phoneExt":22,"email":38},"NEGARIN Akbari, Ph.D",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Negarin Akbari","Assisstant Professor","100595417","the-effect-of-non-pharmacological-methods-on-pain-fear-100595417",false,"NCT07032181","The Effect of Non-pharmacological Methods on Pain, Fear","The Effect of Virtual Reality and Guided Imagery Method Used During Blood Sampling on Pain, Fear","Inclusion Criteria:\n\n* The child must be between 8 and 14 years old.\n* Both the child and the parent must volunteer to participate in the study.\n* The child and the parent must speak Turkish at a native level.\n* The child must not have taken any medication with analgesic, antipyretic, or anti-inflammatory effects within the last 6 hours\n\nExclusion Criteria:\n\n* The child has visual, hearing, or speech impairments.\n* The child is illiterate.\n* The child has a clinical condition that prevents the use of VR glasses or headphones.\n* The child has an allergy to strawberries (mentioned in the guided imagery script) or a fear of forests or squirrels.\n* The child has a disease that may cause chronic pain.\n* The child has any auditory, mental, or neurological disability that could affect participation in the study",true,"ALL","8 Years","14 Years",{"count":71,"type":72},93,"ESTIMATED","INTERVENTIONAL",[75],"NA","This randomized controlled experimental study aims to evaluate the effectiveness of guided imagery and virtual reality (VR) in reducing pain and fear in children during blood draw procedures. The sample will consist of children aged 8-14 who meet the inclusion criteria and present to the Koç Hospital Pediatric Clinic Blood Drawing Room. After informing the children and their parents about the study, written and verbal consents will be obtained. Participants will then be randomly assigned into one of three groups-two experimental (guided imagery and VR) and one control-using a random number list generated via Excel.\n\nPre-procedure: Prior to the intervention, children and parents will be informed using consent forms. Demographic and baseline data will be collected using the Child Patient Introductory Information Form. Pain will be assessed with the Faces Pain Scale-Revised (FPS-R) by the child and the Visual Analog Scale (VAS) by the parent and observer. Fear will be evaluated using the Children's Fear Scale (CFS), self-rated by the child and assessed by the parent\u002Fobserver. A pulse oximeter will be attached to measure baseline pulse and oxygen saturation (SpO2) levels starting 1 minute before the procedure.\n\nGuided Imagery Group: Children will listen to an audio recording titled \"A Walk in the Forest\" using headphones. They will be instructed to close their eyes and imagine the scene described, focusing on the sound to facilitate distraction. The audio will start 1 minute prior to the procedure.\n\nVirtual Reality Group: Children in this group will wear VR glasses and watch an immersive AI-generated video of \"A Walk in the Forest.\" This aims to provide a more interactive distraction during the blood draw.\n\nControl Group: Children will undergo routine blood draw procedures with no additional distraction techniques. The procedure will be explained as usual.\n\nProcedure: A trained nurse will perform all blood draws. During the procedure, SpO2 and pulse data will be recorded. Post-procedure, these will also be documented immediately and 1 minute after the intervention.\n\nPost-procedure: After the procedure, FPS-R and CFS will be used again by children to assess pain and fear. Parents and observers will complete VAS and CFS to evaluate observed pain and fear. Headphones or VR glasses will be removed following the final measurement.",[78,79,80,81],"Children","Pain","Fear","Pediatric ALL",[83,79,80,78,84],"Pediatric","Blood Sampling","NOT_YET_RECRUITING","2025-06-13",{"date":88,"type":89},"2025-06-22","ACTUAL",{"date":91,"type":72},"2025-09-10",{"date":93,"type":72},"2026-09-14",{"name":5,"class":6},1]