Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire

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

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

      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital

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.
The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
Healthy adults
The second group consists of 85 healty participants will given the SSQ-T consists of 17 questions, eating assessment tool-10.
The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turkish Version of Sydney Swallow Questionnaire
Time Frame: Baseline
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.
Baseline
Turkish Version of Sydney Swallow Questionnaire
Time Frame: 2 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Assessment Tool
Time Frame: Baseline
The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Baseline
Penetration and aspiration scale
Time Frame: Baseline
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.
Baseline
YALE scale of pharyngeal residue
Time Frame: Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject demographics
Time Frame: Baseline
The median values of age and ratio of gender in all groups
Baseline

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.

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

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.

Clinical Trials on Swallowing Disorder

Clinical Trials on Turkish Version of Sydney Swallow Questionnaire

3
Subscribe