Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-03 @ 10:36 PM
Study NCT ID:
NCT04465903
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2020-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subject demographics', 'timeFrame': 'Baseline', 'description': 'The median values of age and ratio of gender in all groups'}], 'primaryOutcomes': [{'measure': 'Turkish Version of Sydney Swallow Questionnaire', 'timeFrame': 'Baseline', 'description': 'Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months and healty subjects. The minimum score is 0 and maximum score is 1700. The lower scores mean a normal swallowing function, higher scores mean worst oropharyngeal swallowing functions.'}, {'measure': 'Turkish Version of Sydney Swallow Questionnaire', 'timeFrame': '2 weeks', 'description': 'Turkish version of the questionnaire consists of 17 questions about dysphagia and swallowing functions and dysphagia consequences during patients at least six months. The minimum score is 0 and maximum score is 1700. The lower scores mean is a normal swallowing function, higher scores mean is worst oropharyngeal swallowing functions.'}], 'secondaryOutcomes': [{'measure': 'Eating Assessment Tool', 'timeFrame': 'Baseline', 'description': 'The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.'}, {'measure': 'Penetration and aspiration scale', 'timeFrame': 'Baseline', 'description': 'The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.'}, {'measure': 'YALE scale of pharyngeal residue', 'timeFrame': 'Baseline', 'description': 'The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia, Oropharyngeal', 'Swallowing Disorder', 'Validation']}, 'referencesModule': {'references': [{'pmid': '25330714', 'type': 'RESULT', 'citation': 'Arenaz Bua B, Bulow M. Validation in Swedish of Sydney swallow questionnaire. BMC Res Notes. 2014 Oct 21;7:742. doi: 10.1186/1756-0500-7-742.'}, {'pmid': '30707281', 'type': 'RESULT', 'citation': 'Audag N, Goubau C, Danse E, Vandervelde L, Liistro G, Toussaint M, Reychler G. Validation and Reliability of the French Version of the Sydney Swallow Questionnaire. Dysphagia. 2019 Aug;34(4):556-566. doi: 10.1007/s00455-019-09978-9. Epub 2019 Feb 1.'}, {'pmid': '22350113', 'type': 'RESULT', 'citation': 'Dwivedi RC, St Rose S, Chisholm EJ, Georgalas C, Bisase B, Amen F, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Evaluation of swallowing by Sydney Swallow Questionnaire (SSQ) in oral and oropharyngeal cancer patients treated with primary surgery. Dysphagia. 2012 Dec;27(4):491-7. doi: 10.1007/s00455-012-9395-z. Epub 2012 Feb 21.'}, {'pmid': '10734019', 'type': 'RESULT', 'citation': 'Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study is the validity and reliability of the Turkish version of the Sydney Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish dysphagia patients. Despite being translated and validated in many languages, there is no validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.', 'detailedDescription': 'The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural adaptation guidelines. Two translators translated the SSQ into Turkish and a native English language speaker reverse-translated it into English. The back translation was sent to the original author for proofreading. The SSQ questionnaire consisted of 17 basic questions related with dysphagia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with oropharyngeal dysphagia and healthy adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1:\n\n* Able to speak, read, understand and write in Turkish\n* History of dysphagia during 6 months\n* Age between 18-80 years\n\nGroup 2:\n\n* Able to speak, read, understand and write in Turkish\n* Healthy adults\n* Age between 18-80 years old.\n\nExclusion Criteria:\n\n* Mental disorders\n* Cognitive limitations\n* Able not to speak, read, understand and write in Turkish\n* Underwent any surgery last a month\n* Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy\n* Pregnancy\n* Malignancies\n* Out of age 18-80 years old.'}, 'identificationModule': {'nctId': 'NCT04465903', 'briefTitle': 'Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)', 'orgStudyIdInfo': {'id': '298'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dysphagia patients', 'description': 'The first group consists of 85 dysphagia patients who have at least six months of dysphagia complaints. The participants will given the Turkish version of Sydney Swallow questionnaire (SSQ-T), consisted of 17 questions, eating assessment tool-10 and two scales evaluated with FEES. After the two weeks, 30 participants will given the SSQ-T for sampling.', 'interventionNames': ['Other: Turkish Version of Sydney Swallow Questionnaire']}, {'label': 'Healthy adults', 'description': 'The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.', 'interventionNames': ['Other: Turkish Version of Sydney Swallow Questionnaire']}], 'interventions': [{'name': 'Turkish Version of Sydney Swallow Questionnaire', 'type': 'OTHER', 'description': 'The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.', 'armGroupLabels': ['Dysphagia patients', 'Healthy adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Prof Dr Cemil Tascioglu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Melis Ece Arkan Ararat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, {'name': 'Ugur Uygan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD', 'investigatorFullName': 'Yavuz Atar', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}