Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT07201350
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of an Undersea-Themed ECG Cover on Fear and Anxiety Levels in Children
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes were assessed by two independent nurses who were blinded to group assignments.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were stratified by age and gender, and then assigned to the intervention or control group using block randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-01-06', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fear', 'timeFrame': '2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure', 'description': "Children's fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five faces ranging from 0 (no fear) to 4 (extreme fear). Higher scores indicate higher levels of perceived fear."}, {'measure': 'anxiety', 'timeFrame': '2 minutes before the ECG procedure, at the moment the ECG recording button is pressed, and 2 minutes after the ECG procedure', 'description': "Anxiety will be assessed using the Children's Emotional Manifestation Scale (CEMS), which evaluates five categories of observable emotional behavior. Each item is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher levels of observed anxiety."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'Pediatric ECG', 'Undersea-themed cover', 'Distraction technique', 'Pediatric emergency'], 'conditions': ['Anxiety', 'Fear']}, 'descriptionModule': {'briefSummary': "Aims: To evaluate the impact of an undersea-themed examination table cover (UTETC) designed for electrocardiography (ECG) procedures on fear and anxiety levels in children.\n\nBackground: Children may experience fear and anxiety not only during painful procedures but also during painless interventions such as ECG. The unfamiliar environment, equipment, and separation from caregivers can contribute to emotional distress.\n\nDesign: This is a single-blind, randomized controlled trial.\n\nMethods: The study was conducted with 80 children aged 3-12 years who underwent ECG procedures in a pediatric emergency department. Participants were randomly assigned to either the control group (n = 40) or the intervention group (n = 40) using block randomization. Data were collected using the Child Fear Scale and the Children's Emotional Manifestation Scale.\n\nRelevance to Clinical Practice: The UTETC represents a potential non-pharmacological intervention aimed at improving the emotional comfort of children during ECG procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3 to 12 years\n* Presented to the hospital with chest pain\n* No previous history of heart disease\n* Chest pain with a non-cardiac etiology (e.g., gastrointestinal disorders)\n* Undergoing their first ECG\n\nExclusion Criteria:\n\n-Reported fear of water, being underwater, or swimming'}, 'identificationModule': {'nctId': 'NCT07201350', 'acronym': 'UTETC', 'briefTitle': 'The Effect of an Undersea-Themed ECG Cover on Fear and Anxiety Levels in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Impact on Fear and Anxiety Levels of Children of an Undersea-Themed Cover Designed for Electrocardiography Applications: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UTETC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Other: distraciton technices']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'distraciton technices', 'type': 'OTHER', 'description': 'UTETC is a distraction method used during ECG procedures.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': "r Sami Ulus Maternity and Children's Health and Diseases Training and Research Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'AYLİN ARIKAN', 'investigatorAffiliation': 'Ankara University'}}}}