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NCT Number: NCT06601556

Psychiatric Problems in Thalassemic Children

Aims of the study :

1. Assessment the prevalence of psychiatric problems in thalassemic children . 2. Assessment the prevalence of cognitive problems in thalassemic children . 3. Determine factors associated with psychiatric and cognitive problems in thalassemic children .

Sociodemographic information, other associated factors , CBCL (Child Behaviour Check List) and Children's Sleep Habits Questionnaire will be collected by thalassemic child's caregiver interview at Assiut university ,Children hospital , pediatric hematology unit .

Raven´s Colored Progressive Matrices will be solved by thalassemic patient at Assiut university , Children hospital , pediatric hematology unit .

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Key information

About this study

Beta-thalassemia is a chronic and genetically determined hematological disorder characterized by severe hemolytic anemia as a result of deficient synthesis of β chains of hemoglobin.

β-Thalassemia major is considered the commonest hemoglobinopathy in the Mediterranean area particularly Egypt with an estimated carrier rate of 9-10.2 % . From about registered β-thalassemia cases ; 95% of them are β-thalassemia major, and 5% are thalassemia intermediate.

It demands frequent blood transfusions to maintain life, while haemosiderosis and other complications of the disease require a continuous and distressing treatment regimen that includes parenteral iron chelation treatment and regular medical supervision.

The drawbacks of the disease in many aspects of life become strongly evident during the school age when children ask for independence . It has been related with psychosocial aspect and a significant negative effect on areas of school functioning because of the likelihood of physical deformity, growth retardation and delayed puberty besides the difficulty of management (such as regular transfusion and time-consuming iron chelation treatment) Social stigma associated with having thalassaemia have significant psychosocial and emotional impact on patients and their families(3) , so The affected children become more liable to emotional, social, psychological and behavioural problems .

No available studies about psychiatric problems among thalassemic children in Egypt . Also study that were conducted in the age < 12 years are few .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age between 6 to < 12 years.

Exclusion criteria

  • Patients who had bone marrow transplant and were cured of thalassemia .
  • Neurological illness preventing them from expressing themselves and not able to communicate well

Treatment and study plan

Primary outcomes

  1. • Assessment the prevalence of psychiatric problems in thalassemic children

    Time frame: One year

    By using CBCL (Child Behaviour Check List) is a questionnaire based standardized tool used for assessing behavioural problems(6) . CBCL for school aged children (6-18 years) in local language is filled by the primary caregivers/parents after obtaining written consent . It contains 113 questions categorized into eight domains which are anxious/depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behaviour and aggressive behaviour.(7)

Secondary outcomes

  1. • Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children

    Time frame: One year

    By using Raven´s Colored Progressive Matrices (CPM)-Sets A, AB, B standardized for the population between 6 and 11 years old, comprises 36 items, in which the subject is required to indicate the correct target among six alternatives. Grouped into three sets (A, AB, B) of 12 items in each one, the CPM solving requires different abilities, namely: A Series, requiring visuo-perceptual ability; AB Series, symmetric ability; and B Series, conceptual and analogic thought abilities

    Associated factor by sociodemographic data Name, age, gender, residence (urban or rural and live with family or extended family) and education (student or not , and if not the last degree) and socioeconomic level by by Fahmy and El Sherbini Socio- economic status (SES) scale.the scale consist of 7 domains with total score 84, each domain contain many items that collectively it can measure the socioeconomic status of the family

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Dalia mahran, Professor

CONTACT

[email protected]

+201007120821

Marwa Amary Marwa Amary, Resident doctor

CONTACT

[email protected]

+201110673238

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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