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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005093
Other study ID # HACETTEPE UNI
Secondary ID
Status Completed
Phase N/A
First received December 19, 2016
Last updated August 15, 2017
Start date January 15, 2017
Est. completion date May 15, 2017

Study information

Verified date August 2017
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date May 15, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
CAREGIVERS
The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
CHILDREN OF CAREGIVERS
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.

Locations

Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Turkish Feeding/Swallowing Impact Survey This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties 6 months
Secondary The Karaduman Chewing Performance Scale This scale is used to determine chewing performance level of children 6 months
Secondary Tongue Thrust Rating Scale This scale is used to determine tongue thrust severity of children 6 months
Secondary Pediatric version of the Eating Assessment Tool This tool is used to determine initial dysphagia symptom severity of children 6 months
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