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

NCT ID: NCT06306508

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2024-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis Cystic Fibrosis in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Halic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seda Saka

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haliç University

Istanbul, Eyup, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUvbayraktaroglu

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.