- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03005093
The Turkish Feeding/Swallowing Impact Survey
August 15, 2017 updated by: SELEN SEREL ARSLAN, Hacettepe University
Reliability and Validity of the Turkish Feeding/Swallowing Impact Survey
The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this study is to test the reliability and validity of the Turkish Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of T-EAT-10 will be investigated.
The internal consistency will be assessed using Cronbach's alpha.
Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability.
The criterion validity of the scale will be determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the Eating Assessment Tool.
The validity will also be determined by completion of the Turkish Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric patients.
Study Type
Observational
Enrollment (Actual)
117
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
-
-
-
Ankara, Turkey, 06100
- Hacetttepe University
-
-
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
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Caregivers of pediatric patients with swallowing disorders
Description
Inclusion Criteria:
- Having a child with swallowing disorders aged between 6 months-18 years
Exclusion Criteria:
- Having a child without swallowing disorders
- Having a child with swallowing disorders aged below 6 months
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CAREGIVERS
Caregivers of pediatric patients with swallowing disorders will be recruited.
|
The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
|
CHILDREN OF CAREGIVERS
Pediatric patients with swallowing disorders will be recruited.
|
Chewing performance with Karaduman Chewing Performance Scale, tongue control with Tongue Thrust Rating Scale, dysphagia symptom severity with the Pediatric version of the Eating Assessment Tool will be evaluated.
These assessments will be done before and after swallowing rehabilitation program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Turkish Feeding/Swallowing Impact Survey
Time Frame: 6 months
|
This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Karaduman Chewing Performance Scale
Time Frame: 6 months
|
This scale is used to determine chewing performance level of children
|
6 months
|
Tongue Thrust Rating Scale
Time Frame: 6 months
|
This scale is used to determine tongue thrust severity of children
|
6 months
|
Pediatric version of the Eating Assessment Tool
Time Frame: 6 months
|
This tool is used to determine initial dysphagia symptom severity of children
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 15, 2017
Primary Completion (Actual)
May 15, 2017
Study Completion (Actual)
May 15, 2017
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
December 23, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
August 17, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HACETTEPE UNI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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