- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465903
Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire
July 30, 2021 updated by: Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34384
- Prof Dr Cemil Tascioglu City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults with oropharyngeal dysphagia and healthy adults
Description
Inclusion Criteria:
Group 1:
- Able to speak, read, understand and write in Turkish
- History of dysphagia during 6 months
- Age between 18-80 years
Group 2:
- Able to speak, read, understand and write in Turkish
- Healthy adults
- Age between 18-80 years old.
Exclusion Criteria:
- Mental disorders
- Cognitive limitations
- Able not to speak, read, understand and write in Turkish
- Underwent any surgery last a month
- Underwent laryngectomy/neck dissection/tracheostomy/neck radiotherapy
- Pregnancy
- Malignancies
- Out of age 18-80 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dysphagia patients
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.
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The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
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Healthy adults
The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.
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The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Turkish Version of Sydney Swallow Questionnaire
Time Frame: Baseline
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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.
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Baseline
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Turkish Version of Sydney Swallow Questionnaire
Time Frame: 2 weeks
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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.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Assessment Tool
Time Frame: Baseline
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The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40.
Low score is better, higher score is worse.
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Baseline
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Penetration and aspiration scale
Time Frame: Baseline
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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.
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Baseline
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YALE scale of pharyngeal residue
Time Frame: Baseline
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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.
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject demographics
Time Frame: Baseline
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The median values of age and ratio of gender in all groups
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melis Ece Arkan Ararat, MD, Prof. Dr. Cemil Taşçıoğlu City Hospital
- Principal Investigator: Ugur Uygan, MD, Prof. Dr. Cemil Taşçıoğlu City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 30, 2020
Primary Completion (ACTUAL)
October 30, 2020
Study Completion (ACTUAL)
October 30, 2020
Study Registration Dates
First Submitted
July 3, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (ACTUAL)
July 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 3, 2021
Last Update Submitted That Met QC Criteria
July 30, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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