<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005093</url>
  </required_header>
  <id_info>
    <org_study_id>HACETTEPE UNI</org_study_id>
    <nct_id>NCT03005093</nct_id>
  </id_info>
  <brief_title>The Turkish Feeding/Swallowing Impact Survey</brief_title>
  <official_title>Reliability and Validity of the Turkish Feeding/Swallowing Impact Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the reliability and validity of the Turkish&#xD;
      Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing&#xD;
      disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test the reliability and validity of the Turkish&#xD;
      Feeding/Swallowing Impact Survey among caregivers of pediatric patients with swallowing&#xD;
      disorders.The internal consistency, test-retest reliability, and criterion validity of&#xD;
      T-EAT-10 will be investigated. The internal consistency will be assessed using Cronbach's&#xD;
      alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be&#xD;
      calculated for test-retest reliability. The criterion validity of the scale will be&#xD;
      determined by assessing the correlation between the Turkish Feeding/Swallowing Impact Survey&#xD;
      and Karaduman Chewing Performance Scale, Tongue Thrust Rating Scale, Pediatric version of the&#xD;
      Eating Assessment Tool. The validity will also be determined by completion of the Turkish&#xD;
      Feeding/Swallowing Impact Survey before and after swallowing rehabilitation of pediatric&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Turkish Feeding/Swallowing Impact Survey</measure>
    <time_frame>6 months</time_frame>
    <description>This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Karaduman Chewing Performance Scale</measure>
    <time_frame>6 months</time_frame>
    <description>This scale is used to determine chewing performance level of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tongue Thrust Rating Scale</measure>
    <time_frame>6 months</time_frame>
    <description>This scale is used to determine tongue thrust severity of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric version of the Eating Assessment Tool</measure>
    <time_frame>6 months</time_frame>
    <description>This tool is used to determine initial dysphagia symptom severity of children</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Deglutition Disorder</condition>
  <condition>Dysphagia</condition>
  <condition>Outcome Assessment</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>CAREGIVERS</arm_group_label>
    <description>Caregivers of pediatric patients with swallowing disorders will be recruited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHILDREN OF CAREGIVERS</arm_group_label>
    <description>Pediatric patients with swallowing disorders will be recruited.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAREGIVERS</intervention_name>
    <description>The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers</description>
    <arm_group_label>CAREGIVERS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHILDREN OF CAREGIVERS</intervention_name>
    <description>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.</description>
    <arm_group_label>CHILDREN OF CAREGIVERS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Caregivers of pediatric patients with swallowing disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a child with swallowing disorders aged between 6 months-18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a child without swallowing disorders&#xD;
&#xD;
          -  Having a child with swallowing disorders aged below 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacetttepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SELEN SEREL ARSLAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005093
org study id: HACETTEPE UNI
nct id: NCT03005093
lead sponsor: 
has dmc: Yes
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 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.
observational model: Cohort
time perspective: Prospective
measure: The Turkish Feeding/Swallowing Impact Survey
time frame: 6 months
description: This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties
measure: The Karaduman Chewing Performance Scale
time frame: 6 months
description: This scale is used to determine chewing performance level of children
measure: Tongue Thrust Rating Scale
time frame: 6 months
description: This scale is used to determine tongue thrust severity of children
measure: Pediatric version of the Eating Assessment Tool
time frame: 6 months
description: This tool is used to determine initial dysphagia symptom severity of children
arm group label: CAREGIVERS
description: Caregivers of pediatric patients with swallowing disorders will be recruited.
arm group label: CHILDREN OF CAREGIVERS
description: Pediatric patients with swallowing disorders will be recruited.
intervention type: Other
intervention name: CAREGIVERS
description: The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
arm group label: CAREGIVERS
intervention type: Other
intervention name: CHILDREN OF CAREGIVERS
description: 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.
arm group label: CHILDREN OF CAREGIVERS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: SELEN SEREL ARSLAN, PhD
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SELEN SEREL ARSLAN
investigator title: Principal Investigator
mesh term: Deglutition Disorders
sharing ipd: No