An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers

April 13, 2026 updated by: Selin Soyunmez, Kirsehir Ahi Evran Universitesi

An Intervention-based Approach to Strengthen Life Skills and Psychological Resilience of Children With Cystic Fibrosis and Their Mothers

Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers. The study is conducted in two phases using an advanced mixed-methods intervention design. In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood and its incidence tends to increase. CF affects many systems, especially the respiratory and gastrointestinal systems, and is life-threatening with its progressive course. In addition to the complications that arise due to the disease affecting many systems, the limited life expectancy and poor prognosis also bring psychological and social problems for children and their families. Especially if it is a genetically inherited disease, it may cause the parent to blame himself or herself and experience psychological problems. It is stated that in order to make it easier for children with CF and their families to cope with the negativities brought about by the disease, their psychological resilience levels should be strengthened and health professionals should encourage families to do so. Apart from increasing the level of psychological resilience, other methods that contribute to the reduction of psychological problems include yoga, meditation and laughter yoga. Laughter yoga is a series of exercises that combine gratuitous laughter with yoga breathing techniques, as well as stretching-relaxation techniques, laughter and deep breathing exercises. It is reported that laughter yoga physiologically increases breathing in the body, relaxes muscles, strengthens mental function by reducing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects the quality of life and increases psychological well-being. In this context, an intervention program was created for children with CF and their mothers, including psychological resilience training, laughter yoga, concentrated breathing exercise and meditation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Turkey (Türkiye), 38000
        • Erciyes University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion Criteria for Children:

  • Being between the ages of 8-12,
  • FEV 1 value, which is considered as the acceptance criterion in the terminal period in cystic fibrosis, is over 40%,
  • Not having any physical or mental disability,
  • Ability to communicate in Turkish,
  • Not having an additional diagnosis such as type 1 diabetes or phenyl ketonuria,
  • Volunteering to participate in the research.

Inclusion Criteria for Mothers:

  • Having a child diagnosed with CF between the ages of 8-12,
  • Not having any physical or mental disability,
  • Ability to communicate in Turkish,
  • Volunteering to participate in the research.

Exclusion Criteria:

Exclusion Criteria for Children:

  • Being on mechanical ventilation,
  • Being in the preparation phase for lung transplantation
  • Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.

Exclusion Criteria for Mothers:

  • Lack of internet connection at home,
  • Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Children Intervention Group
Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions).
Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
The content of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers will include the Psychological Resiliency Program for Children and Adolescents developed by Akar (2018), laughter yoga, meditation, breathing exercises and therapeutic story sessions.
Experimental: Mothers Intervention Group
Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions).
Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
The content of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers will include the Psychological Resiliency Program for Children and Adolescents developed by Akar (2018), laughter yoga, meditation, breathing exercises and therapeutic story sessions.
No Intervention: Children Controlled Group
No intervention.
No Intervention: Mothers Controlled Group
No intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Revised Cystic Fibrosis Questionnaire Child Form
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The scale that evaluates the quality of life due to the impact of cystic fibrosis-specific health status is a 4-point Likert type. A higher score indicates a better CF-specific health-related quality of life.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Psychological Resilience Attitude and Skills Scale Child Form
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Scores range from 34 to 136 on the scale, and as the score increases, the level of psychological resilience of children increases.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Brief Psychological Resilience Scale
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
A minimum of 6 and a maximum of 30 points can be obtained from this scale, which will be used to determine the psychological resilience levels of mothers, and higher scores indicate higher psychological resilience.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Functional Disability Inventory Child
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
It is a child self-report tool that evaluates the impact of the disease on physical and psychosocial functioning in daily social roles and daily activities at home and at school. The scale is a 5-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 60. As the score obtained from the scale increases, the level of disability increases.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The Revised Cystic Fibrosis Questionnaire Parent Form
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The CFQ-R Parent version is a self-report instrument consisting of 44 items grouped into 11 domains assessing physical functioning, emotional functioning, vitality, school performance, eating disorders, weight, body image, treatment burden, health perceptions, and respiratory and digestive symptoms. A higher score on the CFQ-R Parent version indicates a better CF-specific health-related quality of life.The total point range is 0-100, with higher scores indicating better CF-specific health-related quality of life.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Depression Anxiety and Stress Scale
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
It will be used to determine mothers' depression, anxiety, and stress levels. The scale is a 4-point Likert type and consists of 3 subscales (depression, anxiety, and stress) and 21 questions. The minimum score that can be obtained from the scale is 0, and the maximum score is 21. A high score on the sub-dimension of the scale indicates that the level of that sub-dimension is high.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Post-Traumatic Growth Scale
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
As the score obtained from this scale, which will be used to determine the post-traumatic growth levels of mothers, increases, the post-traumatic growth level also increases.The scale is a 6-point Likert-type scale, consisting of 5 sub-dimensions and a total of 21 items. The minimum score that can be obtained from the scale is 0, and the maximum score is 105. As the score increases, the level of post-traumatic growth also increases.
The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The Respiratory Function Test
Time Frame: The measurement will start two weeks before the intervention, immediately after the intervention.
Children will have a respiratory function test performed at the center where the research will be conducted. As a result of the rest, the children's FEV1 and FVC values will be examined.
The measurement will start two weeks before the intervention, immediately after the intervention.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirsehir Ahi Evran Universitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TC Erciyes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yağmur Sezer Efe, TC Erciyes University
  • Principal Investigator: Selin Söyünmez, TC Erciyes University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/607

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

product manufactured in and exported from the U.S.

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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