protocolSection identificationModule nctId: NCT06280066, orgStudyIdInfo id: 2023/607, briefTitle: An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, collaborators name: TC Erciyes University, descriptionModule briefSummary: 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., conditionsModule conditions: Cystic Fibrosis, conditions: Children, conditions: Resilience,Psychological, conditions: Laughter Yoga, conditions: Laughter Therapy, conditions: Mothers, conditions: Psychological Health, conditions: Lung Functions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, outcomesModule primaryOutcomes measure: The Respiratory Function Test, primaryOutcomes measure: The Revised Cystic Fibrosis Questionnaire Child Form, primaryOutcomes measure: Psychological Resilience Attitude and Skills Scale Child Form, primaryOutcomes measure: Functional Disability Inventory Child, primaryOutcomes measure: The Revised Cystic Fibrosis Questionnaire Parent Form, primaryOutcomes measure: Depression Anxiety and Stress Scale, primaryOutcomes measure: Post-Traumatic Growth Scale, primaryOutcomes measure: Brief Psychological Resilience Scale, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Erciyes University, city: Kayseri, zip: 38000, country: Turkey, contacts name: Selin Söyünmez, role: CONTACT, phone: +905319762180, email: selinsoyunmez@gmail.com, contacts name: Yağmur Sezer Efe, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Selin Söyünmez, PhD Student, role: PRINCIPAL_INVESTIGATOR, contacts name: Mehmet Köse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False