Swallowing DisorderNCT04477174
Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale
An observational study of Swallowing Disorder and Validation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder, Validation, Pharyngeal Dysphagia
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health professionals
Who may be able to join
- 18-70 years
- at least having undergraduate education on health profession
- agree to participant
Who cannot join
- out of age 18-70 years
- out of having undergraduate education
- mental disorder
- cognitive limitations
- visual limitations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
About this study
Official title: Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T)
Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.
Read the 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 scales. 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 Pharyngeal Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.
- Conditions
- Swallowing Disorder, Validation, Pharyngeal Dysphagia
- Keywords
- Pharyngeal, residue, swallow, scale, Yale
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again. | |
| Group B | Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Pharyngeal Residue Severity Rating Scale
To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Melis Ece Arkan Ararat, MD, Principal investigator, University of Health Sciences, Prof Dr Cemil Tascioglu City HospitalUgur Uygan, MD, Principal investigator, University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477174
- Sponsor's protocol ID
- 308
- Status last verified
- Dec 2020
- First submitted
- 15 Jul 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T)
- ClinicalTrials.gov ID
- NCT04477174
- Acronym / sponsor ID
- 308
- Conditions
- Swallowing Disorder, Validation, Pharyngeal Dysphagia
- Keywords
- Pharyngeal, residue, swallow, scale, Yale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.
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 scales. 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 Pharyngeal Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again. |
| Group B | – | –Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health professionals
Key inclusion criteria (3 listed)
- 18-70 years
- at least having undergraduate education on health profession
- agree to participant
Key exclusion criteria (5 listed)
- out of age 18-70 years
- out of having undergraduate education
- mental disorder
- cognitive limitations
- visual limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of Pharyngeal Residue Severity Rating Scale
Time frame: 2 months
To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melis Ece Arkan Ararat, MD principal investigator
University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
Ugur Uygan, MD principal investigator
University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Disorder and Validation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of Pharyngeal Residue Severity Rating Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.