Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT07203820
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Children's Anxiety and Fear Before Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's State Anxiety", 'timeFrame': '4 months', 'description': 'The scale aims to measure the situational anxiety of children in the 4-10 age group'}, {'measure': "Children's Fear Scale", 'timeFrame': '4 months', 'description': "The scale, which evaluates children's odors with photographs containing facial muscle changes, can be used by children, families, or researchers"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Fear']}, 'descriptionModule': {'briefSummary': "This study was planned as a randomized controlled trial to investigate the effect of ready-made picture template coloring activity on children's anxiety and fear before circumcision. Data is planned to be collected between November 2024 and February 2025 with children between the ages of 5-10 who are planned to be circumcised in a hospital in the Southeastern Anatolia Region. The study consists of painting and control groups. The group in which the participants will be included will be determined by the stratified randomization method. The anxiety status of the children in the painting and control groups will be evaluated using the Children's State Anxiety (CSA) and their fears will be evaluated using the Children's Fear Scale (CFS) based on the reports of both the mother and the child before and after painting. Data collection will be completed before the child is circumcised."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'genderBased': True, 'genderDescription': 'Boys circumcised in Turkey', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages of 5-10,\n* who are planned to be circumcised,\n* who are not in pain, and\n* whose parents approve of participating in the study will be included in the study.\n\nExclusion Criteria:\n\n* Children with mental retardation,\n* bleeding disorders, and\n* traumatic experiences such as death and divorce in the last year will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT07203820', 'briefTitle': "Children's Anxiety and Fear Before Circumcision", 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University'}, 'officialTitle': "The Effect of Ready-made Picture Template Coloring Activity on Children's Anxiety and Fear Before Circumcision: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'HRÜ/24.21.05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ready-Made Picture Template Painting Activity', 'description': 'The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want.', 'interventionNames': ['Behavioral: Ready-Made Picture Template Painting Activity']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No procedures other than routine procedures performed in the hospital will be applied to the children in this group'}], 'interventions': [{'name': 'Ready-Made Picture Template Painting Activity', 'type': 'BEHAVIORAL', 'description': "The purpose of the study will be explained to the children and their parents before the painting process and verbal and written consent will be obtained from the parents who agree to participate in the study. The child will be asked to go to the child with the ready-made picture template and coloring pencils and color the given picture with the colors they want. Children's anxiety will be assessed using the Children's State Anxiety (CSA) and their fears will be assessed using the Children's Fear Scale (CFS) based on both mother's and child's reports before painting and after the painting process is completed (half an hour after the first measurement).", 'armGroupLabels': ['Ready-Made Picture Template Painting Activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Harran University', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Maksude YILDIRIM', 'investigatorAffiliation': 'Adiyaman University'}}}}