Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 7:58 PM
Study NCT ID:
NCT05861232
Status:
UNKNOWN
Last Update Posted:
2023-06-02
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Watching Informative Animation on Fear and Anxiety in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-05-13', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Fear Scale (CFS)', 'timeFrame': '12 MONTHS', 'description': 'The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0 = no concern at all) to fearful (4 = severe anxiety).'}], 'secondaryOutcomes': [{'measure': 'Facial Expressions Rating Scale', 'timeFrame': '12 MONTHS', 'description': "This visual facial scale is a practical method to assess the level of anxiety within a situation. There are six facial expressions, ranging from very happy to very unhappy, and children are asked to choose the one that comes closest to how they feel at that moment. The most positive face is scored as '0' and the most negative face is scored as '5'."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inhalation Therapy; Complications']}, 'descriptionModule': {'briefSummary': "The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.", 'detailedDescription': 'Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:\n\nThe study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023.\n\nPopulation and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The child is 7-12 years of age\n* The family's willingness to participate in the study\n* The child's willingness to participate in the study\n* The child does not have a chronic disease\n\nExclusion Criteria:\n\n* The child has a chronic illness\n* The child has a neurological or mental impairment\n* The child is visually impaired"}, 'identificationModule': {'nctId': 'NCT05861232', 'briefTitle': 'The Effect of Watching Informative Animation on Fear and Anxiety in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'THE EFFECT OF INFORMATIVE ANIMATION WATCHING ON ANXIETY AND FEAR DURING INHALATION THERAPY', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.11/285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'informative animation, anxiety and fear', 'interventionNames': ['Behavioral: Behavioral']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Control not anxiety and fear'}], 'interventions': [{'name': 'Behavioral', 'type': 'BEHAVIORAL', 'description': 'fear and anxiety during inhalation therapy', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Center', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mukader KAYA, WORK DIRECTOR', 'role': 'CONTACT', 'email': 'kader123300@gmail.com', 'phone': '+905455853628'}], 'facility': 'Ataturk University Faculty of Nursing', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Mukader Kaya, graduate student', 'role': 'CONTACT', 'email': 'kader123300@gmail.com', 'phone': '+905455853628'}], 'overallOfficials': [{'name': 'Mukader KAYA, graduate student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ATATÜRK UNİVERSITY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'THE ARTICLE IS INTENDED TO BE SHARED AFTER PUBLICATION.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mukader Kaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'study director', 'investigatorFullName': 'Mukader Kaya', 'investigatorAffiliation': 'Ataturk University'}}}}