- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07802210
Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease
Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease: A Randomized Controlled Trial
Sickle-cell disease (SCD) is a genetic disorder that affects hemoglobin, the molecule in red blood cells responsible for carrying oxygen. The disease causes red blood cells to become rigid and sickle-shaped, leading to blockages in blood flow and subsequent pain and organ damage (World Health Organization (WHO),2025).
Patients with sickle cell disease suffer from various complications of the disease during their lifetime, including anemia, sickle cell crises, acute chest syndrome, stroke, renal failure, retinal detachment and priapism. However, unforeseen and chronic pain crisis are the most common symptoms reported by the patients which are considered as the most common causes of referral to the emergency department and hospital to receive medical care in sickle cell patients (Poku, Atkin,& Kirk,.2023).
Objective(s) of the study:
- To evaluate the effectiveness of Innovative Educational Methods on self-efficacy in children with sickle cell anemia.
- To evaluate the effectiveness of Innovative Educational Methods on self-care capacity in children with sickle cell anemia.
- To find out the relationship between the effectiveness of Innovative Educational Methods on self-efficacy, self-care capacity and demographic characteristics of children with sickle cell anemia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: aula I Al Ali, Phd student
- Phone Number: 0096407733617988
- Email: ula.ibrahim1204a@conursing.uobaghdad.edu.iq
Study Locations
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Iraq
- Pediatric Hematology Center - Ibn Al-Baladi Maternity & Children Hospital and Hereditary Blood Diseases Center, Al-Karamah Teaching Hospital, Baghdad government.
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Contact:
- MOHAMMED Alnedawi
- Phone Number: 07730994914
- Email: hamadly994@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- children with sickle cell anemia and visited Ibn Al-Baladi ,Al-Karamah center for hereditary blood diseases
- age 12-18 years
- being able to read and write
- agrees and willing to participate in the study
Exclusion Criteria:
- children who have a history of mental illness
- children with advanced complications of SCD, such as multi-system organ damage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: video intervention arm
participation in this arm will watch video
|
Participants in this group will watch an educational video lasting under 5 minutes.
The video covers key information about anemia, including its definition, pathophysiology, symptoms, underlying causes, potential complications, and preventive pain crisis in simple way by use AI programs to generation it ."
|
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Experimental: game intervention arm
participation in this arm will play educational game
|
Participants in this group will play an educational game .
The game covers key information about anemia, including its definition, pathophysiology, symptoms, underlying causes, potential complications, and preventive pain crisis in simple way by use AI programs to generation it .
|
|
No Intervention: control arm
participation on this arm will not receive any video or game
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-care capacity level
Time Frame: pre and immediately post intervention and post 2 after 1 month
|
The Appraisal of Self-Care Agency Scale-Revised (ASA-R) According to Orem's self-care theory, Kearney and Fleischer originally developed this scale to assess the health-related self-care capacity level The scale consists of 15 items,
|
pre and immediately post intervention and post 2 after 1 month
|
|
self efficacy
Time Frame: pre and immediately post intervention and post 2 after 1 month
|
Sickle Cell Self-Efficacy Scale (SCSES): The Sickle Cell Self-Efficacy Scale, adapted from Edwards et al. (2001), was used to assess patients' abilities to manage their SCD and carry out daily activities effectively. |
pre and immediately post intervention and post 2 after 1 month
|
Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UB.SCD.adolescent.pt
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
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