Caregiver Awareness About DysphagiaNCT05186961
Determining Dysphagia Awareness in Caregivers
An observational study of Caregiver Awareness About Dysphagia, run by Atılım University.
Trial summary
Genetic, neuromuscular, gastrointestinal, cardiorespiratory diseases and congenital abnormalities can cause dysphagia in children (1, 2). Various symptoms such as coughing during or after feeding, vomiting, recurrent lung infections, inability to gaining weight, difficulty in oromotor control, nasal regurgitation, and… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Awareness About Dysphagia
- How many people
- 25 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
- Healthy volunteers accepted
- Adult
Study population: Persons who provided primary care for children younger than 18 years with swallowing disorders will be included in the study.
Who may be able to join
- Persons who provided primary care for children younger than 18 years with dysphagia
Who cannot join
- Doesn't accept to participate to study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining Pediatric Dysphagia Awareness in Caregivers
Genetic, neuromuscular, gastrointestinal, cardiorespiratory diseases and congenital abnormalities can cause dysphagia in children (1, 2). Various symptoms such as coughing during or after feeding, vomiting, recurrent lung infections, inability to gaining weight, difficulty in oromotor control, nasal regurgitation, and prolonged feeding time can be seen in children whose growth and development are affected due to dysphagia (3).
The primary aim of dysphagia rehabilitation is; gaining a child's age-appropriate nutritional experience by ensuring safe swallowing; supporting growth and development (1). Rehabilitation consists of active or passive oral motor exercises, sensory training, thickened fluids, positioning and their combinations (4, 5). The caregiver is one of the most important partners of the rehabilitation program and should apply feding modifications and positioning for safe swallowing during each feeding. In addition, the exercise approaches recommended by the health personnel should be performed in order to improve the swallowing function at certain times of the day (5).
Read more
According to a study in patients with neurologenic caregivers' failure to comply with dysphagia strategies; chest infections, aspiration pneumonia, prolongation of hospital stay, and adverse clinical outcomes resulting in death (6). Therefore, the role of caregivers is very important in the perisistence and success of rehabilitation is great. The level of knowledge and awareness of the caregiver directly affects the rehabilitation effectiveness.
The knowledge and awareness of the caregiver directly affects the effectiveness of rehabilitation, as it is the caregiver who is most interested and spends time with the child. The caregiver, who has knowledge about dysphagia, symptoms and management, will give the necessary importance to rehabilitation and will be more aware of the child's existing condition. Thus, communication with health personnel will be strengthened, effectiveness of rehabilitation will increase. The aim of this study; to determine the level of knowledge of the caregiver about dysphagias and symptoms.
- Conditions
- Caregiver Awareness About Dysphagia
- Keywords
- caregiver, awareness, dysphagia, children
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| caregivers | Person who provided primary care for children younger than 18 years with swallowing disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Caregiver Awareness:
In order to determine the awareness of dysphagia in caregivers will be asked 6 questions follows. The caregiver will be rate their own level of knowledge on a scale of 1-10. The physiotherapist who made the evaluation will score the caregiver's knowledge level between 1 and 10 in line with the answers.
Caregiver Awareness of Swallowing Disorder Symptoms In order to determine the awareness of the caregiver about the symptoms of swallowing disorders, 10 questions will be asked to the caregiver. The participant will answer each question as yes or no. In addition, the physiotherapist who made the assessment will observe the child during normal feeding and will answer the same questions asked to the participant as yes or no. The difference between the scores of the physiotherapist and caregiver will be used to determine the awareness of the caregiver.
Measured: 1 hour
Secondary outcomes (6)
Demographic Information about caregiver
Age, gender, occupation, education level, family status, and duration of care for a child with swallowing disorder will be recorded.
Measured: 1 hour
Child's Demographic Information
The child's age, gender, diagnosis, other accompanying diseases, nutritional status (oral, non-oral) will be recorded.
Measured: 1 hour
Evaluation of Dysphagia
Pediatric Eating Assessment Tool (PEDI-EAT-10) will be used to determine dysphagia severity and risk of aspiration. PEDI-EAT-10 is a questionnaire consisting of 10 questions answered by caregivers. It scores between 0-40, an increase in the score indicates an increase in the severity of swallowing disorder. (7)
Measured: 1 hour
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)(8).
Measured: 1 hour
Drooling:
Drooling intensity and frequency scale (DSFS) is a valid method used in children. Drooling intensity is examined at 5 levels and drooling frequency is examined at 4 different levels (9).
Measured: 1 hour
Tongue Trust:
The tongue trust rating scale (TTRS), developed by Arslan et al., classifies the tongue thrust reflex severity between 0 and 3 according to the position of the tongue at rest (Level 0= no tongue trust, Level 3= severe tongue trust)(10).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 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 (9)Papers the sponsor has linked to this study.
- Other trials for Caregiver Awareness About DysphagiaStudies 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
- 25 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 Begen, Principal investigator, Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186961
- Sponsor's protocol ID
- GO 20/290
- Status last verified
- Jul 2022
- First submitted
- 26 Dec 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data obtained will be collected in Excel and SPSS files only on the computer whose password is known by the researchers.
Publications
Lefton-Greif MA. Pediatric dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):837-51, ix. doi: 10.1016/j.pmr.2008.05.007.
PubMed 18940644Prasse JE, Kikano GE. An overview of pediatric dysphagia. Clin Pediatr (Phila). 2009 Apr;48(3):247-51. doi: 10.1177/0009922808327323. Epub 2008 Nov 20.
PubMed 19023104van den Engel-Hoek L, Harding C, van Gerven M, Cockerill H. Pediatric feeding and swallowing rehabilitation: An overview. J Pediatr Rehabil Med. 2017 May 16;10(2):95-105. doi: 10.3233/PRM-170435.
PubMed 28582882Chadwick, D. D., Jolliffe, J., & Goldbart, J. (2003). Dysphagia management for adults with learning disabilities: Caregiver knowledge and barriers to their adherence.
Serel Arslan S, Kilinc HE, Yasaroglu OF, Demir N, Karaduman AA. The pediatric version of the eating assessment tool-10 has discriminant ability to detect aspiration in children with neurological impairments. Neurogastroenterol Motil. 2018 Nov;30(11):e13432. doi: 10.1111/nmo.13432. Epub 2018 Aug 13.
PubMed 30101572Serel 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 29727486Rashnoo P, Daniel SJ. Drooling quantification: Correlation of different techniques. Int J Pediatr Otorhinolaryngol. 2015 Aug;79(8):1201-5. doi: 10.1016/j.ijporl.2015.05.010. Epub 2015 May 18.
PubMed 26092552Serel Arslan S, Demir N, Karaduman AA. Reliability and validity of a tool to measure the severity of tongue thrust in children: the Tongue Thrust Rating Scale. J Oral Rehabil. 2017 Feb;44(2):119-124. doi: 10.1111/joor.12471.
PubMed 27973693Borowitz KC, Borowitz SM. Feeding Problems in Infants and Children: Assessment and Etiology. Pediatr Clin North Am. 2018 Feb;65(1):59-72. doi: 10.1016/j.pcl.2017.08.021.
PubMed 29173720
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
- Determining Pediatric Dysphagia Awareness in Caregivers
- ClinicalTrials.gov ID
- NCT05186961
- Acronym / sponsor ID
- GO 20/290
- Conditions
- Caregiver Awareness About Dysphagia
- Keywords
- caregiver, awareness, dysphagia, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 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
- 11 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.
Genetic, neuromuscular, gastrointestinal, cardiorespiratory diseases and congenital abnormalities can cause dysphagia in children (1, 2). Various symptoms such as coughing during or after feeding, vomiting, recurrent lung infections, inability to gaining weight, difficulty in oromotor control, nasal regurgitation, and prolonged feeding time can be seen in children whose growth and development are affected due to dysphagia (3).
The primary aim of dysphagia rehabilitation is; gaining a child's age-appropriate nutritional experience by ensuring safe swallowing; supporting growth and development (1). Rehabilitation consists of active or passive oral motor exercises, sensory training, thickened fluids, positioning and their combinations (4, 5). The caregiver is one of the most important partners of the rehabilitation program and should apply feding modifications and positioning for safe swallowing during each feeding. In addition, the exercise approaches recommended by the health personnel should be performed in order to improve the swallowing function at certain times of the day (5).
According to a study in patients with neurologenic caregivers' failure to comply with dysphagia strategies; chest infections, aspiration pneumonia, prolongation of hospital stay, and adverse clinical outcomes resulting in death (6). Therefore, the role of caregivers is very important in the perisistence and success of rehabilitation is great. The level of knowledge and awareness of the caregiver directly affects the rehabilitation effectiveness.
The knowledge and awareness of the caregiver directly affects the effectiveness of rehabilitation, as it is the caregiver who is most interested and spends time with the child. The caregiver, who has knowledge about dysphagia, symptoms and management, will give the necessary importance to rehabilitation and will be more aware of the child's existing condition. Thus, communication with health personnel will be strengthened, effectiveness of rehabilitation will increase. The aim of this study; to determine the level of knowledge of the caregiver about dysphagias and symptoms.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caregivers | – | –Person who provided primary care for children younger than 18 years with swallowing disorders. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Persons who provided primary care for children younger than 18 years with swallowing disorders will be included in the study.
Key inclusion criteria (1 listed)
- Persons who provided primary care for children younger than 18 years with dysphagia
Key exclusion criteria (1 listed)
- Doesn't accept to 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
Determination of Caregiver Awareness:
Time frame: 1 hour
In order to determine the awareness of dysphagia in caregivers will be asked 6 questions follows. The caregiver will be rate their own level of knowledge on a scale of 1-10. The physiotherapist who made the evaluation will score the caregiver's knowledge level between 1 and 10 in line with the answers. Caregiver Awareness of Swallowing Disorder Symptoms In order to determine the awareness of the caregiver about the symptoms of swallowing disorders, 10 questions will be asked to the caregiver. The participant will answer each question as yes or no. In addition, the physiotherapist who made the assessment will observe the child during normal feeding and will answer the same questions asked to the participant as yes or no. The difference between the scores of the physiotherapist and caregiver will be used to determine the awareness of the caregiver.
6 secondary outcomes
Demographic Information about caregiver
Time frame: 1 hour
Child's Demographic Information
Time frame: 1 hour
Evaluation of Dysphagia
Time frame: 1 hour
Chewing Function:
Time frame: 1 hour
Drooling:
Time frame: 1 hour
Tongue Trust:
Time frame: 1 hour
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 18940644Lefton-Greif MA. Pediatric dysphagia. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):837-51, ix. doi: 10.1016/j.pmr.2008.05.007.
- Background: PubMed 19023104Prasse JE, Kikano GE. An overview of pediatric dysphagia. Clin Pediatr (Phila). 2009 Apr;48(3):247-51. doi: 10.1177/0009922808327323. Epub 2008 Nov 20.
- Background: PubMed 28582882van den Engel-Hoek L, Harding C, van Gerven M, Cockerill H. Pediatric feeding and swallowing rehabilitation: An overview. J Pediatr Rehabil Med. 2017 May 16;10(2):95-105. doi: 10.3233/PRM-170435.
- BackgroundChadwick, D. D., Jolliffe, J., & Goldbart, J. (2003). Dysphagia management for adults with learning disabilities: Caregiver knowledge and barriers to their adherence.
- Background: PubMed 30101572Serel Arslan S, Kilinc HE, Yasaroglu OF, Demir N, Karaduman AA. The pediatric version of the eating assessment tool-10 has discriminant ability to detect aspiration in children with neurological impairments. Neurogastroenterol Motil. 2018 Nov;30(11):e13432. doi: 10.1111/nmo.13432. Epub 2018 Aug 13.
- 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.
- Background: PubMed 26092552Rashnoo P, Daniel SJ. Drooling quantification: Correlation of different techniques. Int J Pediatr Otorhinolaryngol. 2015 Aug;79(8):1201-5. doi: 10.1016/j.ijporl.2015.05.010. Epub 2015 May 18.
- Background: PubMed 27973693Serel Arslan S, Demir N, Karaduman AA. Reliability and validity of a tool to measure the severity of tongue thrust in children: the Tongue Thrust Rating Scale. J Oral Rehabil. 2017 Feb;44(2):119-124. doi: 10.1111/joor.12471.
- Results publication: PubMed 29173720Borowitz KC, Borowitz SM. Feeding Problems in Infants and Children: Assessment and Etiology. Pediatr Clin North Am. 2018 Feb;65(1):59-72. doi: 10.1016/j.pcl.2017.08.021.
- Individual participant dataSharing planned: No. The data obtained will be collected in Excel and SPSS files only on the computer whose password is known by the researchers.
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 Begen 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 About Dysphagia, 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 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?
Determination of Caregiver Awareness: (time frame: 1 hour). 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 NCT05186961, which also lists 9 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.