Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06261112
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Using a Kaleidoscope on Fear and Pain in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'single /investigatör)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assigment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, '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=n0 concern et all) to fearful (4=severe anxietly).'}], 'secondaryOutcomes': [{'measure': 'Facial Expressions Rating Scale', 'timeFrame': '12 MONTHS', 'description': 'This visual facial scale is a practical method to assess rhe 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 as scored as "5".'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture; Complication Orthopedic Procedure']}, 'descriptionModule': {'briefSummary': 'The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data.', 'detailedDescription': 'Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:\n\nThe research was conducted between March 2022 and December 2023 as a randomized controlled experimental study. The study population consisted of patients who sought treatment at the Orthopedics Polyclinic and Emergency Department of Erzurum Atatürk University Health Research and Application Center. These patients were referred to the orthopedics clinic and diagnosed with fractures, such as humerus, wrist, finger, tibia, femur, and ankle fractures, for which plastering was performed as treatment. Specifically, the study included children aged 6 to 12 years. The sample size for the study was determined through a power analysis and ultimately consisted of a total of 70 children, with 35 children assigned to both the control group and the kaleidoscope group. The children in the kaleidoscope group were exposed to a kaleidoscope, while the control group received no intervention beyond routine medical practice. To collect data, the researchers utilized an "Introductory Information Form," the "Wong-Baker Faces Pain Rating Scale," and the "Children Fear Scale." The data were analyzed using percentage distributions, mean, standard deviation, chi-square test, and independent groups t-test. Throughout the research, ethical principles were strictly followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being a child in the 6-12 age group,\n* The child's willingness to participate in the study,\n* The parent's volunteering to participate in the study,\n* Absence of intellectual disability of the child and parent,\n* The child and the parent speak Turkish and are open to communication.\n\nExclusion Criteria:\n\n* The child has a chronic disease that can cause pain,\n* The child has used analgesics within 24 hours before admission to the hospital,\n* The child has visual impairment."}, 'identificationModule': {'nctId': 'NCT06261112', 'briefTitle': 'The Effect of Using a Kaleidoscope on Fear and Pain in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of the Use of Kaleidoscope on Pain and Fear in the Plastering Process of Fracture Emergencies', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.01.11/285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Experimental group kaleideskope, pain and fear', 'interventionNames': ['Other: kaleidescope']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention group', 'description': 'No intervention group Control not pain and fear'}], 'interventions': [{'name': 'kaleidescope', 'type': 'OTHER', 'description': 'used to kaleideskope', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Mihriban ÇULHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mihriban ÇULHA, graduate student ,Ataturk University'}, {'name': 'Mihriban ÇULHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'THE ARTİCLE IS INTENDED TO BE SHARED AFTER PUBLİCATİON'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mihriban Culha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'study director', 'investigatorFullName': 'Mihriban Culha', 'investigatorAffiliation': 'Ataturk University'}}}}