- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06601556
Psychiatric Problems in Thalassemic Children
Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital
Aims of the study :
- Assessment the prevalence of psychiatric problems in thalassemic children .
- Assessment the prevalence of cognitive problems in thalassemic children .
- 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 .
Study Overview
Status
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 .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marwa Amary Marwa Amary, Resident doctor
- Phone Number: +201110673238
- Email: marwa.amary34@gmail.com
Study Contact Backup
- Name: Dalia Dalia mahran, Professor
- Phone Number: +201007120821
- Email: daliaym2001@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• 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)
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• 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 |
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gellan Gellan Karamallah, Lecturer, Assiut University
- Study Director: Khaled Khaled Elsayh, Professor, Assiut University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Psychiatric in thalassemia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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