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Clinical Trial Summary

This study aims to: - Assess the cognitive function in children with beta thalassemia - Evaluate the fatigue in beta thalassemic children - Assess the health related quality of life measures in children with beta thalassemia.


Clinical Trial Description

The cognitive abilities are extremely important for academic achievement. Despite their importance, the evaluation of cognitive function is rarely performed for thalassemia patients. So it is important to assess it and should be a routine comprehensive care of beta thalassemia patients to detect cases that suffer from verbal and performance dysfunction and subject them to the learning skills programs, so investigators can monitor any defects or problems that could arise early. Thalassemia not only affect cognitive abilities, it has also many negative effects on physical health; the patients cannot perform activities easily, get fatigued easily and quickly. Also, emotional and social health aspects are affected. So, assessing health related quality of life is recognized as an indispensable indicator for a general evaluation of patients with thalassemia through which valuable evidence could be provided to improve treatments and to make effective decisions. Cognitive function, fatigue and health related quality of life in children with beta thalassemia will be assessed by using valid and reliable scales. All the patients and controls will be subjected to assessment using the Arabic version of the Wechsler Intelligence Scale for Children which assess cognitive function and provide the output of the Verbal comprehension index ,Perceptual reasoning index, processing speed index, working memory index and a combined Full-Scale IQ test. The assessment included 15 subtests. Health related quality of life will be assessed using the Arabic version of child proxy report of the Pediatric Quality of Life Inventory Generic Core Scale (version 4)( PedsQL). The PedsQL Inventory Generic Core Scales is a brief 23 items multidimensional instrument assessing the physical, emotional, social and school functioning domains. It is a reliable and valid tool designed to measure Health related quality of life The fatigue will be assessed using the Arabic version of child report of the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale which covers three domains, including General Fatigue (6 items), Sleep/Rest Fatigue (6 items) and Cognitive Fatigue (6 items) . Every child will be evaluated alone in spacious and quiet room free from any visual and auditory distractions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05469230
Study type Observational
Source Cairo University
Contact
Status Completed
Phase
Start date January 15, 2022
Completion date May 30, 2023

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