Cystic FibrosisNCT06306508
Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis
An observational study of Cystic Fibrosis and Cystic Fibrosis in Children, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis in Children
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2024to 11 Jul 2024
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis in Children
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified shuttle walk test (MST)
Functional capacity
Measured: only baseline
Secondary outcomes (15)
Forced expiratory volume at one second (FEV1)
It is being evaluated to assess lung function. A spirometry is used for the assessment.
Measured: only baseline
Forced vital capacity (FVC)
It is being evaluated to assess lung function. A spirometry is used for the assessment.
Measured: only baseline
Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC)
It is being evaluated to assess lung function. A spirometry is used for the assessment.
Measured: only baseline
Peak expiratory flow (PEF)
It is being evaluated to assess lung function. A spirometry is used for the assessment.
Measured: only baseline
Maximum inspiratory pressure (MIP)
It is being evaluated to assess inspiratory muscle strength. A intraoral pressure meter device is used for the assessment.
Measured: only baseline
Maximum expiratory pressure (MEP)
It is being evaluated to assess expiratory muscle strength. A intraoral pressure meter device is used for the assessment.
Measured: only baseline
Physical Activity Questionnaire for Children (PAQ-C)
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.
Measured: only baseline
Munich physical fitness test (MFT)
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.
Measured: only baseline
Quadriceps strength
It is being evaluated to assess quadriceps muscle strength. A hand-held dynamometer is used for the assessment.
Measured: only baseline
Handgrip strength
It is being evaluated to assess handgrip strength. A hand dynamometer is used for the assessment.
Measured: only baseline
Cystic Fibrosis Questionnaire Revised (CFQ-R)
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.
Measured: only baseline
Parental Attitude Scale (PAS)
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.
Measured: only baseline
Parent Attitude Scale
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.
Measured: only baseline
Perceived Social Support Scale (PSS)
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.
Measured: only baseline
Breathlessness Beliefs Questionnaire (BBQ)
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.
Measured: only baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start16 Feb 2024
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306508
- Sponsor's protocol ID
- HUvbayraktaroglu
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fidanoglu V, Selcuk Z, Saka S, Cakir E. Dyspnea-related kinesiophobia as a barrier on cystic fibrosis: The role of children and parents. Respir Med. 2025 Nov;248:108364. doi: 10.1016/j.rmed.2025.108364. Epub 2025 Sep 19.
PubMed 40976451
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06306508
- Acronym / sponsor ID
- HUvbayraktaroglu
- Conditions
- Cystic Fibrosis, Cystic Fibrosis in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified shuttle walk test (MST)
Time frame: only baseline
Functional capacity
15 secondary outcomes
Forced expiratory volume at one second (FEV1)
Time frame: only baseline
Forced vital capacity (FVC)
Time frame: only baseline
Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC)
Time frame: only baseline
Peak expiratory flow (PEF)
Time frame: only baseline
Maximum inspiratory pressure (MIP)
Time frame: only baseline
Maximum expiratory pressure (MEP)
Time frame: only baseline
Physical Activity Questionnaire for Children (PAQ-C)
Time frame: only baseline
Munich physical fitness test (MFT)
Time frame: only baseline
Quadriceps strength
Time frame: only baseline
Handgrip strength
Time frame: only baseline
Cystic Fibrosis Questionnaire Revised (CFQ-R)
Time frame: only baseline
Parental Attitude Scale (PAS)
Time frame: only baseline
Parent Attitude Scale
Time frame: only baseline
Perceived Social Support Scale (PSS)
Time frame: only baseline
Breathlessness Beliefs Questionnaire (BBQ)
Time frame: only baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 40976451Fidanoglu V, Selcuk Z, Saka S, Cakir E. Dyspnea-related kinesiophobia as a barrier on cystic fibrosis: The role of children and parents. Respir Med. 2025 Nov;248:108364. doi: 10.1016/j.rmed.2025.108364. Epub 2025 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Cystic Fibrosis in Children, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified shuttle walk test (MST) (time frame: only baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.