Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis

NCT06306508 | Completed

• 1 other identifier: HUvbayraktaroglu
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis in Children

Outcome Measures

Primary Outcomes (1)

• Modified shuttle walk test (MST)

  Functional capacity

  only baseline

Secondary Outcomes (15)

• Forced expiratory volume at one second (FEV1)

  only baseline

• Forced vital capacity (FVC)

  only baseline

• Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC)

  only baseline

• Peak expiratory flow (PEF)

  only baseline

• Maximum inspiratory pressure (MIP)

  only baseline

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• For a child
• To be between 7-17 years old,
• Living with family or caregiver.
• For the parent
• Being the mother, father or other caregiver of the child,
• Voluntarily agreeing to participate in the study on behalf of both the child and oneself.

You may not qualify if:

• For the child
• Having cognitive impairment that would prevent participation in the study or being able to cooperate with the measurements and not being able to adapt,
• History of previous lung or liver transplantation,
• History of hospitalization within the last 1 month,
• Having a neurological or orthopedic comorbidity that affects mobility.
• For the parent
• Having cognitive impairment at a level that prevents participation in the study
• Not living in the same household with the child.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Haliç University

Istanbul, Eyup, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 12, 2024
• Study Start: February 16, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

TU (1)