Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280066
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-01-05
Brief Title:
An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers
Sponsor:
Kirsehir Ahi Evran Universitesi
Organization:
Kirsehir Ahi Evran Universitesi
Study Overview
Official Title:
An Intervention-based Approach to Strengthen Life Skills and Psychological Resilience of Children With Cystic Fibrosis and Their Mothers
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 healthThe 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 mothersIn 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 mothersIn 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 designIn the literature review Gpower analysis was performed α 005 β 099 d 188 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 FormRespiratory 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None