- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05186961
Determining Dysphagia Awareness in Caregivers
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).
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sena Begen, MSc
- Phone Number: +905380929826
- Email: sena.begen@atilim.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Persons who provided primary care for children younger than 18 years with dysphagia
Exclusion Criteria:
- Doesn't accept to participate to study
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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caregivers
Person who provided primary care for children younger than 18 years with swallowing disorders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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. |
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Information about caregiver
Time Frame: 1 hour
|
Age, gender, occupation, education level, family status, and duration of care for a child with swallowing disorder will be recorded.
|
1 hour
|
|
Child's Demographic Information
Time Frame: 1 hour
|
The child's age, gender, diagnosis, other accompanying diseases, nutritional status (oral, non-oral) will be recorded.
|
1 hour
|
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Evaluation of Dysphagia
Time Frame: 1 hour
|
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)
|
1 hour
|
|
Chewing Function:
Time Frame: 1 hour
|
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).
|
1 hour
|
|
Drooling:
Time Frame: 1 hour
|
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).
|
1 hour
|
|
Tongue Trust:
Time Frame: 1 hour
|
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).
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sena Begen, Atilim University, Facultyof Health Sciences Department of Physiotherapy and Rehabilitation
Publications and helpful links
General 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.
- Rashnoo 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.
- Prasse 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.
- van 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.
- Chadwick, 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.
- 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.
- Serel 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.
- Borowitz 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 20/290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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