NCT03005093

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

December 19, 2016

Last Update Submit

August 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The Karaduman Chewing Performance Scale

    6 months

  • Tongue Thrust Rating Scale

    6 months

  • Pediatric version of the Eating Assessment Tool

    6 months

Study Arms (2)

CAREGIVERS

Caregivers of pediatric patients with swallowing disorders will be recruited.

Other: CAREGIVERS

CHILDREN OF CAREGIVERS

Pediatric patients with swallowing disorders will be recruited.

Other: CHILDREN OF CAREGIVERS

Interventions

The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers

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.

CHILDREN OF CAREGIVERS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Caregivers of pediatric patients with swallowing disorders

You may qualify if:

  • Having a child with swallowing disorders aged between 6 months-18 years

You may not qualify if:

  • Having a child without swallowing disorders
  • Having a child with swallowing disorders aged below 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • SELEN SEREL ARSLAN, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 29, 2016

Study Start

January 15, 2017

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations