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

May 26, 2026 updated by: Duygu Demir, University of Yalova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Online Education Group
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.
No Intervention: Control Group
Children in the control group will receive only routine follow-up and standard care. No additional intervention will be provided to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks after the intervention
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.
4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yalova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • duygudemir KF Burcu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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