Turkish Version of Nijmegen Questionnaire

NCT04254952 | Completed

• 1 other identifier: GO 20/199
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to provide Turkish version of Nijmegen Questionnaire for the evaluation of respiratory dysfunction in asthmatic subjects. The incidence of hyperventilation syndrome in asthmatic patients can be determined with the results of the study.

Conditions

Hyperventilation Syndrome

Outcome Measures

Primary Outcomes (5)

• Dyspnea perception

  Dyspnea will be evaluated with a modified Borg scale. The modified Borg scale is a category scale that evaluates dyspnea between the scores of 0-10. Patients will be asked to mark the appropriate value on the scale.

  1st day

• Breathe-holding time

  Individuals are asked to hold their breaths in the sitting position by closing their nostrils and in functional residual volume (after a normal exhalation). In order to eliminate the learning effect, the measurement is repeated three times and the averages of the times are recorded in seconds.

  1st day

• End-tidal CO2 measurement

  A portable capnograph with a nasal cannula will be used for the measurement of mean ETCO2 and resting respiration rate over a ten-minute period. Individuals will be asked to breathe through the nose and not speak during the measurement.

  1st day

• Asthma control test

  Test is used to evaluate asthma control. The questionnaire consists of five items. The total test score ranges from 5 (weak control) to 25 (fully controlled) (14). A total score of \<20 indicates uncontrollable asthma.

  1st day

• Nijmegen Questionnaire

  The Nijmegen Questionnaire has been validated as a screening tool for the detection of hyperventilation syndrome (HVS), consisting 16 items. A score of over 23 out of 64 suggests a positive diagnosis of HVS. It has also been used to detect dysfunctional breathing in patients with asthma.

  1st day

Secondary Outcomes (3)

• Quality of life questionnaire

  1st day

• Disease-specific quality of life

  1st day

• Assessment of anxiety and depression

  1st day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthmatic patients

You may qualify if:

• Having mild to moderate clinically stable asthmatic patients
• Being able to cooperate
• Being 18 years old or older

You may not qualify if:

• Having severe orthopedic, neurological, cardiovascular disorders or cognitive problems
• Unable to cooperte

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Aslihan Cakmak

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

• Deniz Inal-Ince, Prof

  Hacettepe University

  STUDY DIRECTOR

• Gul Karakaya, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Aslihan Cakmak, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Senem Simsek, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: February 5, 2020
• Study Start: September 15, 2019
• Primary Completion: February 21, 2021
• Study Completion: February 21, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)