- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06289972
Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire
March 5, 2024 updated by: Seda Saka, Halic University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
22
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
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having cognitive impairment at a level that prevents cooperation with the scales,
- Not living in the same household with a child with cystic fibrosis.
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 |
---|---|---|
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.
|
baseline, after 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version
Time Frame: baseline, after 15 days
|
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.
|
baseline, after 15 days
|
Parent Attitude Scale (PAS)
Time Frame: baseline, after 15 days
|
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.
|
baseline, after 15 days
|
Perceived Social Support Scale (PSS)
Time Frame: baseline, after 15 days
|
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.
|
baseline, after 15 days
|
Parent Attitude Scale
Time Frame: baseline, after 15 days
|
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.
|
baseline, after 15 days
|
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 20, 2024
Primary Completion (Estimated)
February 20, 2025
Study Completion (Estimated)
February 20, 2025
Study Registration Dates
First Submitted
February 26, 2024
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Actual)
March 4, 2024
Study Record Updates
Last Update Posted (Estimated)
March 6, 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
- HUvbayraktaroglu1
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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