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NCT Number: NCT07304362

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 6-11 years at the time of the study.

Children receiving treatment at the Cystic Fibrosis Diagnosis and Treatment Center during the study period.

Children able to understand and complete the Health Literacy Scales (no visual, auditory, or cognitive impairments that would prevent scale completion).

Children with sufficient proficiency in Turkish to answer the scales.

Children and parents who voluntarily agree to participate.

Children who have not previously received any health literacy education.

Exclusion criteria

Children with severe visual, auditory, or cognitive impairments that would prevent them from understanding or completing the scales.

Children who have already received health literacy education.

Children who are outside the age range of 6-11 years.

Children not receiving follow-up at the Cystic Fibrosis Diagnosis and Treatment Center during the study period.

Treatment and study plan

Online Education Program

Behavioral

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.

Primary outcomes

  1. Children's health literacy levels

    Time frame: 4 weeks after the intervention

    Will be assessed using the Health Literacy Scale for School-Age Children, indicating the child's ability to understand, interpret, and apply health information.

  2. Parents' health literacy levels

    Time frame: 4 weeks after the intervention

    Will be measured via the Turkey Health Literacy Scale-32 to assess parents' ability to understand, interpret, and apply health-related information.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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