Clinical trial NCT06601556: Psychiatric Problems in Thalassemic Children
Official title: Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psychiatric and Thalassemia
Psychiatry and Thalassemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thalassemic patients between 6 and 12 years old

Brief summary: 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 .

Detailed description: 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 \&amp;lt; 12 years are few .

Eligibility criteria: Inclusion Criteria:

* 1. Age between 6 to \&lt; 12 years.

Exclusion Criteria:

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

Primary outcomes:
measure: • Assessment the prevalence of psychiatric problems in thalassemic children
timeFrame: One year
Secondary outcomes:
measure: • Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Gellan Gellan Karamallah, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Khaled Khaled Elsayh, Professor
role: STUDY_DIRECTOR
References: