NCT07802210

Brief 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). 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:

  1. 1.To evaluate the effectiveness of Innovative Educational Methods on self-efficacy in children with sickle cell anemia.
  2. 2.To evaluate the effectiveness of Innovative Educational Methods on self-care capacity in children with sickle cell anemia.
  3. 3.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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 29, 2026

Last Update Submit

August 29, 2026

Conditions

Keywords

sickle cell diseasesickle cell anemiainnovative educationalself efficacyself care agency

Outcome Measures

Primary Outcomes (2)

  • 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,

    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.

    pre and immediately post intervention and post 2 after 1 month

Study Arms (3)

video intervention arm

EXPERIMENTAL

participation in this arm will watch video

Other: video intervention

game intervention arm

EXPERIMENTAL

participation in this arm will play educational game

Other: game intervention

control arm

NO INTERVENTION

participation on this arm will not receive any video or game

Interventions

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 .

game intervention arm

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 ."

video intervention arm

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • children who have a history of mental illness
  • children with advanced complications of SCD, such as multi-system organ damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Center - Ibn Al-Baladi Maternity & Children Hospital and Hereditary Blood Diseases Center, Al-Karamah Teaching Hospital, Baghdad government.

Baghdad, Baghdad Governorate, Iraq

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
P.h.d student

Study Record Dates

First Submitted

August 29, 2026

First Posted

September 3, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations