Healthy Adult ParticipantsBreathe-VQNCT07544472
Validity and Reliability of the Turkish Version of the 'Breathing Vigilance Questionnaire'
An observational study of Healthy Adult Participants, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, assessment questionnaires related to dyspnea measure beliefs about breathing-related symptoms but do not directly measure breath awareness. For this purpose, the Breath Vigilance Questionnaire (BVQ) is a subjective questionnaire developed from the Pain Awareness Questionnaire that directly measures… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Survey using a questionnaire.
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 10 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy Participants
Who may be able to join
- individuals without a self-reported diagnosis of respiratory and/or cardiac problems
- individuals without a COVID-19 diagnosis and/or chronic COVID syndrome ("long COVID") within the last 3 months (primary respiratory dysfunction is excluded as we are dealing with this)
- individuals who can read and write in Turkish
Who cannot join
- Individuals with symptomatic heart disease, a history of lung surgery, neurological disorders, and malignancies that may affect exercise performance, and those with severe cognitive impairment who have difficulty understanding and completing the questionnaire items will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Kütahya, Kütahya, 43020
About this study
In the literature, assessment questionnaires related to dyspnea measure beliefs about breathing-related symptoms but do not directly measure breath awareness. For this purpose, the Breath Vigilance Questionnaire (BVQ) is a subjective questionnaire developed from the Pain Awareness Questionnaire that directly measures breath-specific awareness and includes questions evaluating the interaction between conscious monitoring and control of breathing and anxiety. The questionnaire, consisting of 6 questions, was developed on healthy individuals and its validity and reliability were established. It uses a 5-point Likert scale from 1 (never) to 5 (always), with scores ranging from 6 to 30, and higher scores indicate higher breath awareness .
The reliability and validity of the Turkish version of the Breath Vigilance Questionnaire will assist researchers in assessing dysfunctional breathing and developing treatment strategies by evaluating breath awareness. Therefore, the study aimed to investigate the validity and reliability of the Turkish version.
Read the detailed description
The normal breathing pattern is a synchronized movement progressing from the thorax to the abdominal region, including the pelvis. Any breathing pattern outside of this synchronized movement is called an abnormal breathing pattern or dysfunctional breathing. In recent years, it has been defined as "a change in the normal biomechanical patterns of breathing resulting in intermittent or chronic symptoms related to breathing and/or non-breathing". A 2018 study reported that it was observed more frequently in up to 50% of COPD patients than in asthmatic and healthy individuals. However, it has been reported that respiratory dysfunction can also be observed idiopathically, without any underlying problem (cardiopulmonary or organic cause), and is seen in one out of every five people, due to psychological/behavioral factors such as anxiety, depression, perfectionism, feelings of inferiority.
- Conditions
- Healthy Adult Participants
- Being tested
- Survey using a questionnaire.
- Keywords
- breathing, Awareness, respiration, vigilance
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
survey questions
| Study group | Role | What they receive |
|---|---|---|
| single group | descriptive study Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nijmegan Questionnaire
the Nijmegan Questionnaire, whose Turkish validity and reliability were established by Aslıhan et al., is the most frequently used test for the subjective assessment of dysfunctional respiration. The questionnaire, which allows for the evaluation and description of unexplained respiratory symptoms and signs of hyperventilation, consists of 16 items related to different systems such as cardiovascular, neurological, respiratory, gastrointestinal, and psychological factors, answered on a 5-point scale from 0 (never) to 4 (very often). A score greater than 23 indicates respiratory dysfunction. It has a sensitivity and specificity of 91% and 95%, respectively, regarding the clinical diagnosis of hyperventilation.
Measured: first day
Secondary outcomes (1)
STAI
The Turkish translation of the scale, for which validity and reliability studies have been conducted, includes the State Anxiety Scale section, which aims to assess sudden changes in emotional reactions, and the Trait Anxiety Scale section, which aims to measure the persistence of anxiety that a person generally tends to experience. The 20-item questions in both sections are evaluated using a four-point Likert scale ranging from "Never" to "Completely". For the study, Form 2 will be used, with reference to the original article. In the scoring system, which ranges from 20 to 80 points, lower values indicate low anxiety levels and higher values indicate high anxiety levels.
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Tamer, Kutahya Health Sciences University
- Investigators
- SEVAL TAMER, Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544472
- Sponsor's protocol ID
- Kütahya Health Sciences
- Acronym
- Breathe-VQ
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I wasn't sure about its necessity.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the 'Breathing Vigilance Questionnaire'
- ClinicalTrials.gov ID
- NCT07544472
- Acronym / sponsor ID
- Breathe-VQ / Kütahya Health Sciences
- Conditions
- Healthy Adult Participants
- Keywords
- breathing, Awareness, respiration, vigilance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 22 Apr 2026 (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 the literature, assessment questionnaires related to dyspnea measure beliefs about breathing-related symptoms but do not directly measure breath awareness. For this purpose, the Breath Vigilance Questionnaire (BVQ) is a subjective questionnaire developed from the Pain Awareness Questionnaire that directly measures breath-specific awareness and includes questions evaluating the interaction between conscious monitoring and control of breathing and anxiety. The questionnaire, consisting of 6 questions, was developed on healthy individuals and its validity and reliability were established. It uses a 5-point Likert scale from 1 (never) to 5 (always), with scores ranging from 6 to 30, and higher scores indicate higher breath awareness .
The reliability and validity of the Turkish version of the Breath Vigilance Questionnaire will assist researchers in assessing dysfunctional breathing and developing treatment strategies by evaluating breath awareness. Therefore, the study aimed to investigate the validity and reliability of the Turkish version.
Detailed description
The normal breathing pattern is a synchronized movement progressing from the thorax to the abdominal region, including the pelvis. Any breathing pattern outside of this synchronized movement is called an abnormal breathing pattern or dysfunctional breathing. In recent years, it has been defined as "a change in the normal biomechanical patterns of breathing resulting in intermittent or chronic symptoms related to breathing and/or non-breathing". A 2018 study reported that it was observed more frequently in up to 50% of COPD patients than in asthmatic and healthy individuals. However, it has been reported that respiratory dysfunction can also be observed idiopathically, without any underlying problem (cardiopulmonary or organic cause), and is seen in one out of every five people, due to psychological/behavioral factors such as anxiety, depression, perfectionism, feelings of inferiority.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | – | Other: Survey using a questionnaire.descriptive study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Participants
Key inclusion criteria (3 listed)
- individuals without a self-reported diagnosis of respiratory and/or cardiac problems
- individuals without a COVID-19 diagnosis and/or chronic COVID syndrome ("long COVID") within the last 3 months (primary respiratory dysfunction is excluded as we are dealing with this)
- individuals who can read and write in Turkish
Key exclusion criteria (1 listed)
- Individuals with symptomatic heart disease, a history of lung surgery, neurological disorders, and malignancies that may affect exercise performance, and those with severe cognitive impairment who have difficulty understanding and completing the questionnaire items will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaire.survey questions | Other | single group |
Primary outcome
Nijmegan Questionnaire
Time frame: first day
the Nijmegan Questionnaire, whose Turkish validity and reliability were established by Aslıhan et al., is the most frequently used test for the subjective assessment of dysfunctional respiration. The questionnaire, which allows for the evaluation and description of unexplained respiratory symptoms and signs of hyperventilation, consists of 16 items related to different systems such as cardiovascular, neurological, respiratory, gastrointestinal, and psychological factors, answered on a 5-point scale from 0 (never) to 4 (very often). A score greater than 23 indicates respiratory dysfunction. It has a sensitivity and specificity of 91% and 95%, respectively, regarding the clinical diagnosis of hyperventilation.
1 secondary outcome
STAI
Time frame: first day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- main articleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I wasn't sure about its necessity.
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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.
SEVAL TAMER principal investigator
Kütahya Health Sciences 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 Healthy Adult Participants, run by Kutahya Health Sciences 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVAL TAMER (+90 506 865 42 68, seval.tamer@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nijmegan Questionnaire (time frame: first day). 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 22 Apr 2026.