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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280066
• Other study ID #: 2023/607
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Selin Söyünmez
• Phone: +905319762180
• Email: selinsoyunmez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi	TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, and 1 and 3 months after the intervention.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.