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Completed

NCT Number: NCT04465903

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

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.

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Key information

Conditions

Dysphagia, Oropharyngeal Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder Validation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Turkish Version of Sydney Swallow Questionnaire

Other

The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Subject demographics

    Time frame: Baseline

    The median values of age and ratio of gender in all groups

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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