Clinical trial NCT06280066: An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers
Official title: An Intervention-based Approach to Strengthen Life Skills and Psychological Resilience of Children With Cystic Fibrosis and Their Mothers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cystic Fibrosis
Children
Resilience,Psychological
Laughter Yoga
Laughter Therapy
Mothers
Psychological Health
Lung Functions
Keywords: cystic fibrosis
children
psychological resilience
laughter yoga
laughter therapy
mothers
psychological health
lung functions
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2024-02-28
Enrollment: 28
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Respiratory Function Test
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention.
measure: The Revised Cystic Fibrosis Questionnaire Child Form
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: Psychological Resilience Attitude and Skills Scale Child Form
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: Functional Disability Inventory Child
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: The Revised Cystic Fibrosis Questionnaire Parent Form
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: Depression Anxiety and Stress Scale
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: Post-Traumatic Growth Scale
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
measure: Brief Psychological Resilience Scale
timeFrame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Yağmur Sezer Efe
role: PRINCIPAL_INVESTIGATOR
affiliation: TC Erciyes University
name: Selin Söyünmez
role: PRINCIPAL_INVESTIGATOR
References: