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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06407908
Other study ID # REC/RCR&AHS/23/0788
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date June 28, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Imran Amjad, PhD
Phone 9233224390125
Email Imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among infants born prematurely, with low birth weight, and with complex medical disorders. The Eating Assessment Tool (EAT-10), consisting of 10 items, was first developed for infant patients. (PEDI-EAT-10) will be translated into Urdu language by using forward backwards translation method. Two bilingual speakers expert in both Urdu and English languages will assist the researcher in the forward translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.


Description:

A mix method approach will be applied 1. Forward translation 2. Reconciliation of items 3. Backward translation 4. Review of forward and backward translation 5. Pre-testing (cognitive interviewing) 6. Validation study The process of translation followed the guidelines in the translation manual. Translators translate the pediatric version of eating assessment tool (Pedi-EAT-10), independently from each other into the Urdu language considering the following guidelines: using natural language acceptable to the broader public, performing a clear, simple, and understandable translation, avoiding lengthy and complicated sentences. This will be followed by a backward translation to ensure that the content, from the conceptual point of view, had not been modified in the translation. A native English translator was requested to carry out the back-translation, and all discrepancies were identified and corrected. To show whether all items are easily understood and acceptable to the patients, pretesting the final translated questionnaire will be conducted by administering it to patients with a varying education level. The questions that were not easily understood were discussed and redrafted by a panel of researchers until all interviewees understood all items.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 28, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 15 Years
Eligibility Inclusion Criteria: - Parents of children diagnosed with eating disorders - Age from 3 to 15 years Exclusion Criteria: - Parents with children Unable to understand the questionnaire - Parents with children who have Intellectual disability and any organic type of incontinence, neurological or anatomical problems - Parents with who have children Severe cognitive decline or dementia - Parents with children cannot understand Urdu.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Version of the Eating Assessment Tool (Pedi-EAT-10) This resource is essential for determining how these obstacles affect a child's health and food consumption. The pediatric version is specially designed to evaluate a child's eating and swallowing skills, taking into consideration their specific developmental and physiological needs. 6 months
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