Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 6:17 AM
Study NCT ID:
NCT03005093
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Turkish Feeding/Swallowing Impact Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Turkish Feeding/Swallowing Impact Survey', 'timeFrame': '6 months', 'description': 'This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties'}], 'secondaryOutcomes': [{'measure': 'The Karaduman Chewing Performance Scale', 'timeFrame': '6 months', 'description': 'This scale is used to determine chewing performance level of children'}, {'measure': 'Tongue Thrust Rating Scale', 'timeFrame': '6 months', 'description': 'This scale is used to determine tongue thrust severity of children'}, {'measure': 'Pediatric version of the Eating Assessment Tool', 'timeFrame': '6 months', 'description': 'This tool is used to determine initial dysphagia symptom severity of children'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Deglutition Disorder', 'Dysphagia', 'Outcome Assessment', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.', 'detailedDescription': "The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of T-EAT-10 will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the Eating Assessment Tool. The validity will also be determined by completion of the Turkish Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Caregivers of pediatric patients with swallowing disorders', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a child with swallowing disorders aged between 6 months-18 years\n\nExclusion Criteria:\n\n* Having a child without swallowing disorders\n* Having a child with swallowing disorders aged below 6 months'}, 'identificationModule': {'nctId': 'NCT03005093', 'briefTitle': 'The Turkish Feeding/Swallowing Impact Survey', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Reliability and Validity of the Turkish Feeding/Swallowing Impact Survey', 'orgStudyIdInfo': {'id': 'HACETTEPE UNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAREGIVERS', 'description': 'Caregivers of pediatric patients with swallowing disorders will be recruited.', 'interventionNames': ['Other: CAREGIVERS']}, {'label': 'CHILDREN OF CAREGIVERS', 'description': 'Pediatric patients with swallowing disorders will be recruited.', 'interventionNames': ['Other: CHILDREN OF CAREGIVERS']}], 'interventions': [{'name': 'CAREGIVERS', 'type': 'OTHER', 'description': 'The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers', 'armGroupLabels': ['CAREGIVERS']}, {'name': 'CHILDREN OF CAREGIVERS', 'type': 'OTHER', 'description': 'Chewing performance with Karaduman Chewing Performance Scale, tongue control with Tongue Thrust Rating Scale, dysphagia symptom severity with the Pediatric version of the Eating Assessment Tool will be evaluated. These assessments will be done before and after swallowing rehabilitation program.', 'armGroupLabels': ['CHILDREN OF CAREGIVERS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacetttepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'SELEN SEREL ARSLAN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SELEN SEREL ARSLAN', 'investigatorAffiliation': 'Hacettepe University'}}}}