Cystic FibrosisNCT06289972
Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire
An observational study of Cystic Fibrosis and Parents, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Cystic Fibrosis, Parents
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study will consist of parents of CF patients who come to the Pediatric Chest Diseases Outpatient Clinic of a private hospital for routine control. The sample will consist of parents who fulfill the inclusion and exclusion criteria and volunteer to participate in the study.
Who may be able to join
- To be between 25-75 years old,
- To be literate in Turkish,
- Being a mother, father or other caregiver of a child,
- Voluntarily agreeing to participate in the study,
- Be taking care of the child for at least one year
Who cannot join
- Having cognitive impairment at a level that prevents cooperation with the scales,
- Not living in the same household with a child with cystic fibrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire
The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.
Read the detailed description
Cystic fibrosis (CF) is an inherited disease characterized by pulmonary involvement. Children with CF may have obstructive lung disease and related dyspnea, which may progress to respiratory failure and mortality. Dyspnea may lead to activity limitation. Parents who take care of children with CF may be protective of their children's social environment for some reasons such as the risk of infection. The Breathlessness Beliefs Questionnaire (BBQ) is a Turkish validated scale developed to assess dysfunctional beliefs about dyspnea. Based on the idea that parents may develop dysfunctional dyspnea belief behavior in their children with CF, the aim of this study was to develop a caregiver version of the BBQ (The Breathlessness Beliefs Questionnaire Caregiver Version-BBQ-C) and to investigate the validity and reliability of the scale in assessing dysfunctional dyspnea beliefs in parents of children with CF.
- Conditions
- Cystic Fibrosis, Parents
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C)
The BBQ-C will assess dysfunctional dyspnea beliefs in caregivers.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: baseline, after 15 days
Secondary outcomes (4)
Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version
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. 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: baseline, after 15 days
Parent Attitude Scale (PAS)
The PAS is assess to perceived parental attitude according to child.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: baseline, after 15 days
Perceived Social Support Scale (PSS)
The PSS is assess to perceived social support according to child. 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: baseline, after 15 days
Parent Attitude Scale
Parent Attitude Scale is assess to perceived parental attitude according to parent. 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: baseline, after 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start20 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.
- 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
- Prospective
- Enrolment
- 42 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
- NCT06289972
- Sponsor's protocol ID
- HUvbayraktaroglu1
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Development, Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire
- ClinicalTrials.gov ID
- NCT06289972
- Acronym / sponsor ID
- HUvbayraktaroglu1
- Conditions
- Cystic Fibrosis, Parents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 4 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.
The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.
Detailed description
Cystic fibrosis (CF) is an inherited disease characterized by pulmonary involvement. Children with CF may have obstructive lung disease and related dyspnea, which may progress to respiratory failure and mortality. Dyspnea may lead to activity limitation. Parents who take care of children with CF may be protective of their children's social environment for some reasons such as the risk of infection. The Breathlessness Beliefs Questionnaire (BBQ) is a Turkish validated scale developed to assess dysfunctional beliefs about dyspnea. Based on the idea that parents may develop dysfunctional dyspnea belief behavior in their children with CF, the aim of this study was to develop a caregiver version of the BBQ (The Breathlessness Beliefs Questionnaire Caregiver Version-BBQ-C) and to investigate the validity and reliability of the scale in assessing dysfunctional dyspnea beliefs in parents of children with CF.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study will consist of parents of CF patients who come to the Pediatric Chest Diseases Outpatient Clinic of a private hospital for routine control. The sample will consist of parents who fulfill the inclusion and exclusion criteria and volunteer to participate in the study.
Key inclusion criteria (5 listed)
- To be between 25-75 years old,
- To be literate in Turkish,
- Being a mother, father or other caregiver of a child,
- Voluntarily agreeing to participate in the study,
- Be taking care of the child for at least one year
Key exclusion criteria (2 listed)
- Having cognitive impairment at a level that prevents cooperation with the scales,
- Not living in the same household with a child with cystic fibrosis.
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
The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C)
Time frame: baseline, after 15 days
The BBQ-C will assess dysfunctional dyspnea beliefs in caregivers.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.
4 secondary outcomes
Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version
Time frame: baseline, after 15 days
Parent Attitude Scale (PAS)
Time frame: baseline, after 15 days
Perceived Social Support Scale (PSS)
Time frame: baseline, after 15 days
Parent Attitude Scale
Time frame: baseline, after 15 days
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.
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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 Parents, 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 5 inclusion and 2 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?
The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C) (time frame: baseline, after 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.