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

NCT06280066 | Completed

• 1 other identifier: 2023/607
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis; Children; Psychological Health; Resilience,Psychological; Laughter Yoga; Laughter Therapy; Mothers; Lung Functions

Keywords

cystic fibrosis; children; psychological resilience; laughter yoga; laughter therapy; mothers; psychological health; lung functions

Outcome Measures

Primary Outcomes (8)

• The Respiratory Function Test

  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.

• The Revised Cystic Fibrosis Questionnaire Child Form

  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

  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.

• Functional Disability Inventory Child

  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

  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

  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

  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.

• Brief Psychological Resilience Scale

  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.

Study Arms (4)

Children Intervention Group

EXPERIMENTAL

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

Mothers Intervention Group

EXPERIMENTAL

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

Children Controlled Group

NO INTERVENTION

No intervention.

Mothers Controlled Group

NO INTERVENTION

No intervention.

Interventions

Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers OTHER

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.

Children Intervention Group; Mothers Intervention Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Personal Satisfaction; Behavior

Study Officials

• Yağmur Sezer Efe

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• Selin Söyünmez

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Advanced mixed-methods intervention design.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 28, 2024
• Study Start: April 2, 2024
• Primary Completion: June 2, 2024
• Study Completion: July 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)