Trials / Completed

CompletedNCT06280066

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 28 (actual)

Sponsor: Kirsehir Ahi Evran Universitesi · Academic / Other
Sex: All
Age: 8 Years – 12 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-04-02
Primary completion: 2024-06-02
Completion: 2025-07-30
First posted: 2024-02-28
Last updated: 2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06280066. Inclusion in this directory is not an endorsement.