跳至主要内容
临床试验/NCT06601556
NCT06601556尚未招募不适用

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

Assiut University0 个研究点目标入组 150 人开始时间: 2024年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
• Assessment the prevalence of psychiatric problems in thalassemic children

研究概览

简要总结

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 .

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 6 to < 12 years.

排除标准

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

结局指标

主要结局

• Assessment the prevalence of psychiatric problems in thalassemic children

时间窗: 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)

次要结局

  • • Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Amary

Resident doctor

Assiut University

相似试验

Psychiatric Problems in Thalassemic Children | 临床试验