Psychiatric Problems in Thalassemic Children

NCT ID: NCT06601556

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2026-03-20

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 < 12 years are few .

Conditions

Psychiatric and Thalassemia; Psychiatry and Thalassemia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 1. Age between 6 to < 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Amary

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gellan Gellan Karamallah, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Khaled Khaled Elsayh, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Marwa Amary Marwa Amary, Resident doctor

Role: CONTACT

marwa.amary34@gmail.com

+201110673238

Dalia Dalia mahran, Professor

Role: CONTACT

daliaym2001@yahoo.com

+201007120821

Other Identifiers

Psychiatric in thalassemia

Identifier Type: -

Identifier Source: org_study_id