NCT05196217

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2 days

First QC Date

December 26, 2021

Last Update Submit

July 18, 2022

Conditions

Keywords

caregiverawarenessexperiencechewing problem

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Chewing Function

    1 day

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Being a primary caregiver of oral feding children, followed about cheming and swallowimg problem more than 6 months.

You may qualify if:

  • being a primary caregiver of oral feding children, followed about chewing and swallowing problem more than 6 months

You may not qualify if:

  • Don't except participate to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28393655BACKGROUND
  • Serel Arslan S, Aydin G, Alemdaroglu I, Tunca Yilmaz O, 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.

    PMID: 29727486BACKGROUND
  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006;3(2):77-101.

    BACKGROUND

Study Officials

  • Selen Serel Arslan, assoc. prof.

    Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY

    STUDY DIRECTOR
  • Sena N Begen, MSc

    Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

December 26, 2021

First Posted

January 19, 2022

Study Start

July 30, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

For a qualitative content analysis, The thematic analysis process involved multiple distinct phases as described by Braun and Clarke: the stages of familiarizing yourself with your data, generating initial codes, searching for themes, reviewing themes, defining and naming themes, producing the report (1). First, all interviews will be transcribed. A researcher will check the manuscripts, correct ıf there any mistake and make them anonymous. After the codes are determined. 2 researchers will come together at weekly meetings to discuss and develop themes. This approach will continue until no new information becomes available (theoretical saturation).