- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06306508
Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis
March 5, 2024 updated by: Seda Saka, Halic University
Investigation of the Effect of Parental Illness Beliefs and Anxiety Level on Functional and Physical Level of the Child in Children With Cystic Fibrosis
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Eyup
-
Istanbul, Eyup, Turkey, 34060
- Recruiting
- Haliç University
-
Contact:
- Vildan Bayraktaroglu, PT, MSc
- Phone Number: (0212) 924 24 44
- Email: vildanbayraktaroglu@halic.edu.tr
-
Principal Investigator:
- Seda Saka, PT, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified shuttle walk test (MST)
Time Frame: only baseline
|
Functional capacity
|
only baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory volume at one second (FEV1)
Time Frame: only baseline
|
It is being evaluated to assess lung function.
A spirometry is used for the assessment.
|
only baseline
|
Forced vital capacity (FVC)
Time Frame: only baseline
|
It is being evaluated to assess lung function.
A spirometry is used for the assessment.
|
only baseline
|
Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC)
Time Frame: only baseline
|
It is being evaluated to assess lung function.
A spirometry is used for the assessment.
|
only baseline
|
Peak expiratory flow (PEF)
Time Frame: only baseline
|
It is being evaluated to assess lung function.
A spirometry is used for the assessment.
|
only baseline
|
Maximum inspiratory pressure (MIP)
Time Frame: only baseline
|
It is being evaluated to assess inspiratory muscle strength.
A intraoral pressure meter device is used for the assessment.
|
only baseline
|
Maximum expiratory pressure (MEP)
Time Frame: only baseline
|
It is being evaluated to assess expiratory muscle strength.
A intraoral pressure meter device is used for the assessment.
|
only baseline
|
Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: only baseline
|
The PAQ-C is a scale that assesses moderate to vigorous physical activity over the past seven days.
For each item of the questionnaire, except for the tenth question that inquires about the disease status, an evaluation is made on a 5-point scale and an activity score between 1-5 is found.
After the scores of the answers given to the nine questions are summed and divided by the number of questions, the score obtained is the total physical activity score of the child from the questionnaire.
An average score of "1" indicates a low level of physical activity, while an average score of "5" indicates high physical activity.
|
only baseline
|
Munich physical fitness test (MFT)
Time Frame: only baseline
|
The test consists of six parameters: ball bounce, target catch, forward bending, vertical jump, hang and step test.
With this test, peer comparison according to age and gender and interpretation of motor performance can be made with objective scores.
The total fitness score is the average of the six parameter scores.
Physical fitness is classified as inadequate (≤35), normal (36-45), adequate (46-55), good (56-65) or very good (≥66) according to the total score.
|
only baseline
|
Quadriceps strength
Time Frame: only baseline
|
It is being evaluated to assess quadriceps muscle strength.
A hand-held dynamometer is used for the assessment.
|
only baseline
|
Handgrip strength
Time Frame: only baseline
|
It is being evaluated to assess handgrip strength.
A hand dynamometer is used for the assessment.
|
only baseline
|
Cystic Fibrosis Questionnaire Revised (CFQ-R)
Time Frame: only baseline
|
The CFQ-R assesses quality of life.
The CFQ-R is a cystic fibrosis-specific scale developed separately for both the child and the parent.
Both versions are used in this study.
The child version of the questionnaire consists of 35 items and the parent version consists of 50 items.
Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized.
Scores range from 0 to 100, with higher scores indicating better health.
CD-Rom Program available for scoring the CFQ-R.
|
only baseline
|
Parental Attitude Scale (PAS)
Time Frame: only baseline
|
The PAS was developed to measure parents' child-rearing attitudes.
Democratic (17 items), Authoritarian (11 items), Overprotective (9 items), Permissive (9 items).
In scoring, scores and corresponding responses were 5 for "always", 4 for "most of the time", 3 for "sometimes", 2 for "rarely" and 1 for "never".
Having a high score meant to adopt the behavior style represented by that domain.
|
only baseline
|
Parent Attitude Scale
Time Frame: only baseline
|
The scale has three sub-dimensions: acceptance/affection, control/supervision and psychological autonomy.
Accordingly, since the scale is scored as Always 5; Mostly 4; No opinion 3; Occasionally 2; Never 1, the individual to whom the scale is applied receives a minimum score of 15 and a maximum score of 75 from each dimension separately.
Each dimension is evaluated according to whether the scores are low or high.
In whichever dimension the score is higher, it is accepted that the child perceives parental attitude in that way.
|
only baseline
|
Perceived Social Support Scale (PSS)
Time Frame: only baseline
|
PSS was developed to measure the social support perceived by children.
The scale includes 5 items on social support perceived from mother and 5 items on social support perceived from father, and 4 items on social support perceived from peers.
A minimum of 14 points and a maximum of 70 points can be obtained from the scale.
As the total score increases, the child's perception of social support increases.
|
only baseline
|
Breathlessness Beliefs Questionnaire (BBQ)
Time Frame: only baseline
|
The questionnaire was developed based on the Tampa Kinesiophobia Scale to assess patients' dysfunctional beliefs about dyspnea due to reduced physical activity.
The items question the patient's beliefs about the effects of dyspnea and whether activity should be avoided.
The questionnaire has a minimum score of 11 and a maximum score of 55.
As the total score increases, the belief in dysfunctional dyspnea increases.
|
only baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2024
Primary Completion (Estimated)
February 16, 2025
Study Completion (Estimated)
February 16, 2025
Study Registration Dates
First Submitted
February 26, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUvbayraktaroglu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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