DyspneaNCT03517826
Validity and Reliability of The Turkish Version of Breathlessness Beliefs Questionnaire
An observational study of Dyspnea and COPD, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to evaluate the validity and reliability of the Turkish version of the Breathlessness Beliefs Questionnaire-BBQ in our study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2018to 10 Dec 2018
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- FEV1/FVC<%70
- To be able to read and understand Turkish
Who cannot join
- Having undergone a COPD exacerbation in the last 6 weeks
- Having comorbidities affecting ambulance
- Having cognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of The Turkish Version of Breathlessness Beliefs
In our study, we aimed to evaluate the validity and reliability of the Turkish version of the Breathlessness Beliefs Questionnaire-BBQ in our study.
Read the detailed description
Pulmonary diseases are a common cause of mortality and morbidity throughout the world. In pulmonary diseases such as asthma and COPD, the main symptom is dyspnea and it causes activity limitation. Dyspnea is defined as the difficulty that a person experiences during breathing. As a result of painful situations or injuries, avoidance of physical activity or movement due to the fear of repetition of the problem are defined as kinesophobia. Pulmonary patients are compensated by reducing the rate of activity, while avoiding dyspnea.This reduces the severity of the symptom that precedes the symptom that may occur. As a result, dyspnea causes kinesyphobia. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, quality of life is reduced. The Breathlessness Beliefs Questionnaire (BBQ) was developed based on the Tampa Kinesiophobia Scale to assess dyspnea and dyspnoea-related kinesophobia and anxiety in respiratory diseases.
- Keywords
- COPD, Dyspnea, Kinesiophobia
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness Beliefs Questionnaire-BBQ
Breathlessness Beliefs Questionnaire-BBQ Breathlessness Perception Questionnaire; is a measure evaluating kinesophobia and anxiety due to the breathlessness of 17 questions answered by one's own practice. Patients score from 1 to 5 (I strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.
Measured: 3 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start25 Apr 2018
- Primary completion1 Nov 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Bezmialem Vakif University
- Investigators
- Seda Saka, MSc, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517826
- Sponsor's protocol ID
- bvussaka02
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Peuter S, Janssens T, Van Diest I, Stans L, Troosters T, Decramer M, Van den Bergh O, Vlaeyen JW. Dyspnea-related anxiety: The Dutch version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2011;8(1):11-9. doi: 10.1177/1479972310383592. Epub 2010 Dec 20.
PubMed 21172990Wu Q, Guo A, Zhao Y, Li S, Huang H. Reliability and validity of the Chinese version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2018 May;15(2):114-122. doi: 10.1177/1479972317715551. Epub 2017 Jun 21.
PubMed 28635313
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of The Turkish Version of Breathlessness Beliefs
- ClinicalTrials.gov ID
- NCT03517826
- Acronym / sponsor ID
- bvussaka02
- Keywords
- COPD, Dyspnea, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 7 May 2018 (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.
In our study, we aimed to evaluate the validity and reliability of the Turkish version of the Breathlessness Beliefs Questionnaire-BBQ in our study.
Detailed description
Pulmonary diseases are a common cause of mortality and morbidity throughout the world. In pulmonary diseases such as asthma and COPD, the main symptom is dyspnea and it causes activity limitation. Dyspnea is defined as the difficulty that a person experiences during breathing. As a result of painful situations or injuries, avoidance of physical activity or movement due to the fear of repetition of the problem are defined as kinesophobia. Pulmonary patients are compensated by reducing the rate of activity, while avoiding dyspnea.This reduces the severity of the symptom that precedes the symptom that may occur. As a result, dyspnea causes kinesyphobia. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, quality of life is reduced. The Breathlessness Beliefs Questionnaire (BBQ) was developed based on the Tampa Kinesiophobia Scale to assess dyspnea and dyspnoea-related kinesophobia and anxiety in respiratory diseases.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (2 listed)
- FEV1/FVC<%70
- To be able to read and understand Turkish
Key exclusion criteria (3 listed)
- Having undergone a COPD exacerbation in the last 6 weeks
- Having comorbidities affecting ambulance
- Having cognitive disorders
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
Breathlessness Beliefs Questionnaire-BBQ
Time frame: 3 Minutes
Breathlessness Beliefs Questionnaire-BBQ Breathlessness Perception Questionnaire; is a measure evaluating kinesophobia and anxiety due to the breathlessness of 17 questions answered by one's own practice. Patients score from 1 to 5 (I strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.
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 4 Feb 2019.
- Results publication: PubMed 21172990De Peuter S, Janssens T, Van Diest I, Stans L, Troosters T, Decramer M, Van den Bergh O, Vlaeyen JW. Dyspnea-related anxiety: The Dutch version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2011;8(1):11-9. doi: 10.1177/1479972310383592. Epub 2010 Dec 20.
- Results publication: PubMed 28635313Wu Q, Guo A, Zhao Y, Li S, Huang H. Reliability and validity of the Chinese version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2018 May;15(2):114-122. doi: 10.1177/1479972317715551. Epub 2017 Jun 21.
- Individual participant dataSharing planned: Undecided
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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.
Seda Saka, MSc principal investigator
Bezmialem Vakif University
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 Dyspnea and COPD, run by Bezmialem Vakif 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 2 inclusion and 3 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 4 Feb 2019. 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?
Breathlessness Beliefs Questionnaire-BBQ (time frame: 3 Minutes). 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 NCT03517826, which also lists 2 linked publications.
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 4 Feb 2019.