Turkish Version of Nijmegen Questionnaire

Hyperventilation Syndrome Clinical Trial

Official title:

The Validity and Reliability of the Turkish Version of the Nijmegen Questionnaire in Evaluating Respiratory Dysfunction in Asthmatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254952
• Other study ID #: GO 20/199
• Status: Completed
• Start date: September 15, 2019
• Est. completion date: February 21, 2021

Study information

• Verified date: May 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Nijmegen Questionnaire allows to assess and identify respiratory symptoms and dysfunction, and to assess unexplained respiratory symptoms and symptoms of hyperventilation syndrome. Determining whether Turkish version of Nijmegen Questionnaire is a valid and reliable tool in asthmatic individuals will guide researchers for further studies on identifying appropriate treatment approaches for the patient and developing different treatment strategies. Hyperventilation syndrome is a recognized form of respiratory dysfunction associated with biochemical factors. Hyperventilation syndrome is defined as breathing above the body's metabolic requirements. This results in decreased carbon dioxide pressure in the arterial blood, respiratory alkalosis, and increased symptoms. Complex symptoms such as shortness of breath, chest tightness, paresthesia, anxiety, and dizziness may occur. There is no laboratory test which is the gold standard in the diagnosis of hyperventilation syndrome. If it is concluded that the Turkish version of the Nijmegen Questionnaire is a valid and reliable test in individuals with asthma, a new tool will be introduced to the literature for the evaluation of pulmonary dysfunction in asthmatic individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 21, 2021
• Est. primary completion date: February 21, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hyperventilation
• Hyperventilation Syndrome

Locations

Country	Name	City	State
Turkey	Aslihan Cakmak	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Quality of life questionnaire	The overall quality of life will be determined by the Nottingham Health Profile (NHP). The NHP consists of 38 substances that the individual can complete without the need for a person. The questionnaire has six sub scales: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items) and physical mobility (8 items). For each subsection there is a possible range of points ranging from 0-100 points. Higher scores indicate more limitations in quality of life.	1st day
Secondary	Disease-specific quality of life	Disease-specific quality of life will be determined by the Asthma Quality of Life Questionnaire (AQLQ). The Asthma Quality of Life Questionnaire was found to be valid and reliable in Turkish. The quality of life questionnaire in individuals with asthma is a 32-item disease-specific questionnaire in four health domains, including activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). Scores range 1-7, with higher scores indicating better quality of life.	1st day
Secondary	Assessment of anxiety and depression	The Beck Depression Inventory (BDI) measures physical, emotional, cognitive, and motivational symptoms of depression. The aim of the scale is to determine the level of depression symptoms and the change in severity. BDI is a scale that includes 21 self-assessment sentences and there are four options in each symptom category. Each item is scored between 0-3 points and the total score varies between 0 and 63. The validity and reliability study of the scale was conducted in Turkish. The cut-off value of the Turkish form was determined to be 17.	1st day