- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Sena N Begen, MSc
- Telefonnummer: +905380929826
- E-post: sena.begen@atilim.edu.tr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Familiebasert
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
chewing awareness
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Chewing Function
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sena N Begen, MSc, Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GO 20/290-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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