NCT07544472

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 6, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

breathingAwarenessrespirationvigilance

Outcome Measures

Primary Outcomes (1)

  • 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.

    first day

Secondary Outcomes (1)

  • STAI

    first day

Study Arms (1)

single group

descriptive study

Other: Survey using a questionnaire.

Interventions

survey questions

single group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Participants

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Kütahya, 43020, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • SEVAL TAMER

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof . Dr

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 22, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

June 10, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations