- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196217
CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHEWING PROBLEM
CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHILDREN WITH CHEWING PROBLEMS
Chewing is the process of making the food taken into the mouth as a bolus with rhythmic, coordinated, and sequential movements. To normal chewing function oral and perioral sensory integrity; adequate lip closure and intraoral pressure; intraoral bolus transport; normal structure and coordination of lips, palate, tongue, jaw joint, chewing muscles should be ensured. Problems that occur in bolus formation starting from taking food into the mouth are called chewing problems.
The underlying cause of the chewing problem can be very diverse. The chewing problem can be seen in genetic, neuromuscular, gastrointestinal pediatric diseases as well as cognitive, behavioral problems or in healthy children. Many different health professionals take part in the rehabilitation of the chewing problem, but the family is at the center of the rehabilitation. For this reason, the level of knowledge, experience, and approach of the family is very important.
The aim of this study is to determine the swallowing-chewing problem knowledge levels, experiences and approaches of the caregivers of the child with chewing problems.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sena N Begen, MSc
- Phone Number: +905380929826
- Email: sena.begen@atilim.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- being a primary caregiver of oral feding children, followed about chewing and swallowing problem more than 6 months
Exclusion Criteria:
- Don't except participate to study
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chewing awareness
Time Frame: 1 day
|
A one-to-one interview will be held with the caregivers in a quiet room, accompanied by a voice recorder.
During interview; caregivers perspective, experiences and knowledge of the child's chewing and swallowing problem will be ask.
The interviews will continue for a minimum of 20 minutes until sufficient data is collected for thematic analysis.
15 participants will be included in the study.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chewing Function
Time Frame: 1 day
|
Karaduman Chewing Performance Scale (KCPS) developed by developed by Arslan et al., chewing function is classified at 5 different levels between 0 - 4 (Level 0= normal chewing function, Level 4= The child cannot bite and chew).
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sena N Begen, MSc, Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
Publications and helpful links
General Publications
- Serel Arslan S, Inal O, Demir N, Olmez MS, Karaduman AA. Chewing side preference is associated with hemispheric laterality in healthy adults. Somatosens Mot Res. 2017 Jun;34(2):92-95. doi: 10.1080/08990220.2017.1308923. Epub 2017 Apr 10.
- Serel Arslan S, Aydın G, Alemdaroğlu I, Tunca Yılmaz Ö, Karaduman AA. Reliability and validity of the Karaduman Chewing Performance Scale in paediatric neuromuscular diseases: A system for classification of chewing disorders. J Oral Rehabil. 2018 Jul;45(7):526-531. doi: 10.1111/joor.12642. Epub 2018 May 20.
- Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GO 20/290-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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