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

K

Kirsehir Ahi Evran Universitesi

Status

Invitation-only

Conditions

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

Treatments

Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers

Study type

Interventional

Funder types

Other

Identifiers

NCT06280066
2023/607

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 4 patient groups

Children Intervention Group
Experimental group
Description:
Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions).
Treatment:
Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
Mothers Intervention Group
Experimental group
Description:
Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions).
Treatment:
Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
Children Controlled Group
No Intervention group
Description:
No intervention.
Mothers Controlled Group
No Intervention group
Description:
No intervention.

Trial contacts and locations

1

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Central trial contact

Selin Söyünmez; Yağmur Sezer Efe

Data sourced from clinicaltrials.gov

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