Clinical trial NCT04465903: Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire
Official title: Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire (SSQ-T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia, Oropharyngeal
Swallowing Disorder
Validation
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with oropharyngeal dysphagia and healthy adults

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Turkish Version of Sydney Swallow Questionnaire
timeFrame: Baseline
measure: Turkish Version of Sydney Swallow Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Eating Assessment Tool
timeFrame: Baseline
measure: Penetration and aspiration scale
timeFrame: Baseline
measure: YALE scale of pharyngeal residue
timeFrame: Baseline
Other outcomes:
measure: Subject demographics
timeFrame: Baseline
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Tascioglu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: Melis Ece Arkan Ararat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: Ugur Uygan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.