NCT07304362

The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy

The Effect of Education Given to School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy Levels

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: University of Yalova · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled experimental study is planned to examine the effect of an online education program provided to school-age children aged 6-11 years diagnosed with cystic fibrosis and their parents on health literacy levels. The study population will consist of 123 school-age children with cystic fibrosis and their parents who are followed at the Cystic Fibrosis Outpatient Clinic of Marmara University Pendik Training and Research Hospital. The study sample will include 104 children and their parents, who will be randomly assigned to either the intervention group (n = 52) or the control group (n = 52). Data will be collected using the Introductory Information Form, the Health Literacy Scale for School-Age Children, and the Turkey Health Literacy Scale-32. Following the pre-test assessments, an online education program developed by the researcher will be delivered to the intervention group. The control group will not receive any additional intervention. Both groups will complete post-test assessments four weeks after the pre-test.

Detailed description

The study population will consist of school-age children aged 6-11 years who are diagnosed with cystic fibrosis and meet the inclusion criteria, along with their parents, followed at the Cystic Fibrosis Outpatient Clinic of Marmara University Pendik Training and Research Hospital. This study is planned to be designed as a randomized controlled experimental study with a pretest-posttest design in order to determine the effect of an online education program that will be delivered to children with cystic fibrosis and their parents on health literacy levels. The study will aim to evaluate parents' ability to understand, evaluate, and use health information accurately, as well as children's understanding of their disease, their responsibility in managing their health, and the development of healthy lifestyle behaviors. To ensure homogeneous distribution of the groups, randomization will be performed using a computer-based system (http://www.randomization.com, balanced permutation method). Children who meet the inclusion criteria and whose parents provide consent will be randomly assigned to either the intervention group or the control group according to the randomization list. The online education program, developed by the researcher, will be administered to the intervention group following the pretest. The control group will not receive any additional intervention. Both groups will complete posttest assessments four weeks after the pretest. Study Variables • Independent Variable: The independent variable of the study will be the online education program that will be delivered to school-age children with cystic fibrosis and their parents. • Dependent Variables: The dependent variables will be the health literacy levels of children diagnosed with cystic fibrosis and their parents. • Control Variables: The control variables will include the descriptive characteristics of the children (age, gender).

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
BEHAVIORAL	Online Education Program	Children with cystic fibrosis and their parents in the intervention group will receive an online education program designed to improve health literacy. The program will be delivered once, immediately after the pretest, through an online platform. The session will last approximately 30-40 minutes and will follow a standardized educational protocol reviewed by expert faculty members. Posttest assessment will be conducted 4 weeks after the intervention. The program aims to enhance parents' ability to interpret, apply, and make decisions based on health information, and to help children understand and take responsibility for their own health.

Timeline

• Start date: 2025-06-10
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Turkey (Türkiye)