Sickle Cell Anemia in ChildrenNCT07802210
Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease
A study testing video intervention and game intervention in people with Sickle Cell Anemia in Children, run by Aula Ibrahim abd alrazak at 1 site in Iraq.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Sickle Cell Anemia in Children
- What is being tested?
- video intervention and game intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- children who have a history of mental illness
- children with advanced complications of SCD, such as multi-system organ damage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Pediatric Hematology Center - Ibn Al-Baladi Maternity & Children Hospital and Hereditary Blood Diseases Center, Al-Karamah Teaching Hospital, Baghdad government.
Baghdad, Baghdad Governorate
MOHAMMED Alnedawi, 07730994914, hamadly994@gmail.com
About this study
Official title: 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).
Read more
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.
- Conditions
- Sickle Cell Anemia in Children
- Being tested
- video intervention, game intervention
- Keywords
- sickle cell disease, sickle cell anemia, innovative educational, self efficacy, self care agency
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video interventionOther
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 ."
game interventionOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| video intervention arm | Experimental | participation in this arm will watch video Receives: Other: video intervention |
| game intervention arm | Experimental | participation in this arm will play educational game Receives: Other: game intervention |
| control arm | No intervention | participation on this arm will not receive any video or game |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-care capacity level
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,
Measured: pre and immediately post intervention and post 2 after 1 month
self efficacy
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.
Measured: pre and immediately post intervention and post 2 after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Anemia in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Ibrahim abd alrazak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aula Ibrahim abd alrazak, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802210
- Sponsor's protocol ID
- UB.SCD.adolescent.pt
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Innovative Educational Methods in Empowering Children With Sickle Cell Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07802210
- Acronym / sponsor ID
- UB.SCD.adolescent.pt
- Conditions
- Sickle Cell Anemia in Children
- Keywords
- sickle cell disease, sickle cell anemia, innovative educational, self efficacy, self care agency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aula Ibrahim abd alrazakUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| video intervention arm | Experimental | Other: video interventionparticipation in this arm will watch video |
| game intervention arm | Experimental | Other: game interventionparticipation in this arm will play educational game |
| control arm | No intervention | –participation on this arm will not receive any video or game |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- children who have a history of mental illness
- children with advanced complications of SCD, such as multi-system organ damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video interventionParticipants 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 ." | Other | video intervention arm |
| game interventionParticipants 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 . | Other | game intervention arm |
Primary outcome
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,
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Anemia in Children
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Active, not recruitingPhase 2
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Sickle Cell Anemia in Children
Recruiting
Exercise in Child Health
Cystic Fibrosis, Sickle Cell Disease
RecruitingPhase 2
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video intervention and game intervention in people with Sickle Cell Anemia in Children, run by Aula Ibrahim abd alrazak at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aula I Al Ali, Phd student (0096407733617988, ula.ibrahim1204a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-care capacity level (time frame: pre and immediately post intervention and post 2 after 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.