Caregiver AwarenessNCT05196217
CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHEWING PROBLEM
An observational study of Caregiver Awareness and Chewing Problem, run by Atılım University.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Caregiver Awareness, Chewing Problem
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2022to 1 Sep 2022
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- Adult
Study population: Being a primary caregiver of oral feding children, followed about cheming and swallowimg problem more than 6 months.
Who may be able to join
- being a primary caregiver of oral feding children, followed about chewing and swallowing problem more than 6 months
Who cannot join
- Don't except participate to study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Caregiver Awareness, Chewing Problem
- Keywords
- caregiver, awareness, experience, chewing problem
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start30 Jul 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caregiver AwarenessStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Nur Begen, Atılım University
- Investigators
- Selen Serel Arslan, assoc. prof., Study director, Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEYSena N Begen, MSc, Principal investigator, Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196217
- Sponsor's protocol ID
- GO 20/290-1
- Status last verified
- Jul 2022
- First submitted
- 26 Dec 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
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.
PubMed 28393655Serel 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.
PubMed 29727486Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006;3(2):77-101.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAREGIVER KNOWLEDGE AND EXPERIENCE OF CHILDREN WITH CHEWING PROBLEMS
- ClinicalTrials.gov ID
- NCT05196217
- Acronym / sponsor ID
- GO 20/290-1
- Conditions
- Caregiver Awareness, Chewing Problem
- Keywords
- caregiver, awareness, experience, chewing problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- 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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Being a primary caregiver of oral feding children, followed about cheming and swallowimg problem more than 6 months.
Key inclusion criteria (1 listed)
- being a primary caregiver of oral feding children, followed about chewing and swallowing problem more than 6 months
Key exclusion criteria (1 listed)
- Don't except participate to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Chewing Function
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 28393655Serel 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.
- Background: PubMed 29727486Serel 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.
- BackgroundBraun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006;3(2):77-101.
- Individual participant dataSharing planned: No. 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).
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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, assoc. prof. study director
Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
Sena N Begen, MSc principal investigator
Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Awareness and Chewing Problem, run by Atılım University.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sena N Begen, MSc (+905380929826, sena.begen@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chewing awareness (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196217, which also lists 3 linked publications.
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 20 Jul 2022.