Clinical trial NCT06306508: Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis
Official title: Investigation of the Effect of Parental Illness Beliefs and Anxiety Level on Functional and Physical Level of the Child in Children With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Cystic Fibrosis in Children
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 43
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cystic fibrosis and their parents who visited a private hospital's Pediatric Chest Diseases Outpatient Clinic made up the study's population. 37 parents of children with cystic fibrosis and their 37 offspring who match the inclusion and exclusion criteria and willingly consent to take part in the study will make up the sample.

Brief summary: Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study.

Detailed description: Cystic fibrosis (CF) is an inherited disease characterized by pulmonary involvement. Children with CF may have low levels of physical activity, physical fitness and functional capacity, and peripheral muscle weakness. Parents who take care of children with CF may be protective of their children's social environment due to reasons such as the risk of infection. Based on the idea that parents may have potential limitations on their children with CF, the aim of this study was to examine the effect of parental illness beliefs and anxiety levels on the functional and physical level of the child. Children with CF will be administered Modified Shuttle Walking Test, Munich Physical Fitness Test, quadriceps muscle strength and hand grip strength test, respiratory function and respiratory muscle strength test, Child Physical Activity Questionnaire, Shortness of Breath Beliefs Questionnaire, Revised Cystic Fibrosis Questionnaire, Parental Attitude Scale, Perceived Social Support Scale. Parents will be administered the Shortness of Breath Beliefs Questionnaire (Parent version), Revised Cystic Fibrosis Questionnaire (Parent version), Parent Attitude Scale, Fear of Disease Progression Questionnaire for Parents. The level of correlation between the outcomes of the scales administered to parents and the assessment outcomes administered to children will be examined.

Eligibility criteria: * Inclusion Criteria:

  1. For a child

     1. To be between 7-17 years old,
     2. Living with family or caregiver.
  2. For the parent

     1. Being the mother, father or other caregiver of the child,
     2. Voluntarily agreeing to participate in the study on behalf of both the child and oneself.
* Exclusion Criteria:

  1. For the child

     1. Having cognitive impairment that would prevent participation in the study or being able to cooperate with the measurements and not being able to adapt,
     2. History of previous lung or liver transplantation,
     3. History of hospitalization within the last 1 month,
     4. Having a neurological or orthopedic comorbidity that affects mobility.
  2. For the parent

     1. Having cognitive impairment at a level that prevents participation in the study
     2. Not living in the same household with the child.

Primary outcomes:
measure: Modified shuttle walk test (MST)
timeFrame: only baseline
Secondary outcomes:
measure: Forced expiratory volume at one second (FEV1)
timeFrame: only baseline
measure: Forced vital capacity (FVC)
timeFrame: only baseline
measure: Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC)
timeFrame: only baseline
measure: Peak expiratory flow (PEF)
timeFrame: only baseline
measure: Maximum inspiratory pressure (MIP)
timeFrame: only baseline
measure: Maximum expiratory pressure (MEP)
timeFrame: only baseline
measure: Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: only baseline
measure: Munich physical fitness test (MFT)
timeFrame: only baseline
measure: Quadriceps strength
timeFrame: only baseline
measure: Handgrip strength
timeFrame: only baseline
measure: Cystic Fibrosis Questionnaire Revised (CFQ-R)
timeFrame: only baseline
measure: Parental Attitude Scale (PAS)
timeFrame: only baseline
measure: Parent Attitude Scale
timeFrame: only baseline
measure: Perceived Social Support Scale (PSS)
timeFrame: only baseline
measure: Breathlessness Beliefs Questionnaire (BBQ)
timeFrame: only baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haliç University
state: Eyup
Study officials:
References: