Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

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Brief Title

Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

Official Title

Assessment of Cognitive Function, Fatigue and Health Related Quality of Life in Children With Beta Thalassemia

Brief 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.
    

Detailed 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 Type

Observational


Primary Outcome

assessing the change in cognitive function


Condition

Cognitive Change


Study Arms / Comparison Groups

 Typically developed children group
Description:  Typically developed children will be from both genders. the age range will be (8-16) years old and will be recruited from public governmental schools

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

January 15, 2022

Completion Date

December 30, 2022

Primary Completion Date

August 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Beta thalassemia group (Study group): Both genders will be included and their age
             range from 8 to 16 years old

          -  Typically developed children (control group):

               -  Healthy children will be recruited from public governmental schools

               -  Healthy controls, matching the patients in age, gender and educational level.

               -  It will be ensured from their past medical history and clinical examination that
                  they and their first-degree relatives never had any chronic disease, including
                  thalassemia.

               -  Both genders will be included

               -  Their age range from 8 to 16 years old

        Exclusion Criteria:

          -  Beta thalassemia group (study group): Any child Suffering from any other chronic
             diseases other than thalassemia

             • Having visual or auditory problems

          -  Typically developed children (control group):

        any child suffering from medical illness, musculoskeletal deformities, visual and auditory
        problems.
      

Gender

All

Ages

8 Years - 16 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Esraa ibrahim, M.Sc, 01011267858, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05469230

Organization ID

P.T.REC/012/003783


Responsible Party

Principal Investigator

Study Sponsor

Cairo University


Study Sponsor

Esraa ibrahim, M.Sc, Principal Investigator, Cairo University


Verification Date

July 2022