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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05196217
Other study ID # GO 20/290-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 30, 2022
Est. completion date September 1, 2022

Study information

Verified date July 2022
Source Atilim University
Contact Sena N Begen, MSc
Phone +905380929826
Email sena.begen@atilim.edu.tr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date September 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Atilim University

References & Publications (3)

Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006;3(2):77-101.

Serel Arslan S, Aydin G, Alemdaroglu I, Tunca Yilmaz 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. — View Citation

Serel Arslan S, Inal Ö, Demir N, Ölmez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary chewing awareness 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 Chewing Function 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
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