Deglutition DisorderNCT03005093
The Turkish Feeding/Swallowing Impact Survey
An observational study of Deglutition Disorder and Dysphagia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorder, Dysphagia, Outcome Assessment
- What is being tested?
- CAREGIVERS and CHILDREN OF CAREGIVERS
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2017to 15 May 2017
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caregivers of pediatric patients with swallowing disorders
Who may be able to join
- Having a child with swallowing disorders aged between 6 months-18 years
Who cannot join
- Having a child without swallowing disorders
- Having a child with swallowing disorders aged below 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Deglutition Disorder, Dysphagia, Outcome Assessment, Quality of Life
- Being tested
- CAREGIVERS, CHILDREN OF CAREGIVERS
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREGIVERSOther
The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
CHILDREN OF CAREGIVERSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CAREGIVERS | Caregivers of pediatric patients with swallowing disorders will be recruited. Receives: Other: CAREGIVERS | |
| CHILDREN OF CAREGIVERS | Pediatric patients with swallowing disorders will be recruited. Receives: Other: CHILDREN OF CAREGIVERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish Feeding/Swallowing Impact Survey
This scale is used to determine the concerns of caregivers related to their children feeding/swallowing difficulties
Measured: 6 months
Secondary outcomes (3)
The Karaduman Chewing Performance Scale
This scale is used to determine chewing performance level of children
Measured: 6 months
Tongue Thrust Rating Scale
This scale is used to determine tongue thrust severity of children
Measured: 6 months
Pediatric version of the Eating Assessment Tool
This tool is used to determine initial dysphagia symptom severity of children
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start15 Jan 2017
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005093
- Sponsor's protocol ID
- HACETTEPE UNI
- Status last verified
- Aug 2017
- First submitted
- 19 Dec 2016
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Feeding/Swallowing Impact Survey
- ClinicalTrials.gov ID
- NCT03005093
- Acronym / sponsor ID
- HACETTEPE UNI
- Conditions
- Deglutition Disorder, Dysphagia, Outcome Assessment, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAREGIVERS | – | Other: CAREGIVERSCaregivers of pediatric patients with swallowing disorders will be recruited. |
| CHILDREN OF CAREGIVERS | – | Other: CHILDREN OF CAREGIVERSPediatric patients with swallowing disorders will be recruited. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers of pediatric patients with swallowing disorders
Key inclusion criteria (1 listed)
- Having a child with swallowing disorders aged between 6 months-18 years
Key exclusion criteria (2 listed)
- Having a child without swallowing disorders
- Having a child with swallowing disorders aged below 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREGIVERSThe Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers | Other | CAREGIVERS |
| CHILDREN OF CAREGIVERSChewing 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. | Other | CHILDREN OF CAREGIVERS |
Primary outcome
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
3 secondary outcomes
The Karaduman Chewing Performance Scale
Time frame: 6 months
Tongue Thrust Rating Scale
Time frame: 6 months
Pediatric version of the Eating Assessment Tool
Time frame: 6 months
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 17 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Deglutition Disorder
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis
IBM, Inclusion Body Myositis
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
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.
SELEN SEREL ARSLAN, PhD principal investigator
Hacettepe University
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 Deglutition Disorder and Dysphagia, run by Hacettepe University 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 1 inclusion and 2 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 17 Aug 2017. 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?
The Turkish Feeding/Swallowing Impact Survey (time frame: 6 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 17 Aug 2017.