Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04696562 |
| Other study ID # |
OCengiz |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2021 |
| Est. completion date |
April 30, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Ankara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The world is facing an extremely important global epidemic. Coronavirus disease 2019
(COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected
all countries of the world, was declared as a pandemic by the World Health Organization (WHO)
on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and
throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging
from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress
Syndrome-ARDS). COVID-19 has many symptoms (i.e. fever, loss of appetite). In cases where the
disease has a more severe course, in addition to the symptoms mentioned above, complications
such as a severe pneumonia, acute respiratory distress syndrome (ARDS) kidney failure and
fatal heart damage may develop. Dyspnea is one of the most prominent symptoms for COVID-19.
Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important
place in the treatment of patients. Dyspnea is one of the most prominent symptoms for
COVID-19. Our clinical observations are of the opinion that dyspnea is observed even in
patients with mild COVID-19 pneumonia. Applying deep breathing exercise with triflo in
COVID-19 patients, can contribute to relieving dyspnea, reducing / eliminating anxiety, and
increasing quality of life. In the light of this information, the aim of this study is to
determine the effect of deep breathing exercise with triflo on dyspnea, anxiety and quality
of life in patients with dyspnea who are hospitalized for COVID-19.
Research Hypotheses H1: Patients with COVID-19 pneumonia who undergo deep breathing exercise
with triflo will have a lower dyspnea level than the patient group in which this exercise is
not applied.
H2: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will
have a lower anxiety level than the patient group in whom this exercise was not applied.
H3: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will
have a higher quality of life than the patient group in whom this exercise was not applied.
Description:
The world is facing an extremely important global epidemic. Coronavirus disease 2019
(COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected
all countries of the world, was declared as a pandemic by the World Health Organization (WHO)
on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and
throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging
from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress
Syndrome-ARDS). COVID-19 has many symptoms. Dyspnea is one of the most prominent symptoms for
COVID-19. The relationship between dyspneaand COVID-19 is not fully explained. Our clinical
observations are of the opinion that dyspnea is observed even in patients with mild COVID-19
pneumonia.
Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important
place in the treatment of patients. Deep breathing exercise applied within the scope of
pulmonary rehabilitation expands the airways, facilitates gas exchange, increases the amount
of oxygen reaching the cells, provides the release of tracheabronchial secretions, regulates
the pulmonary circulation and thus increases the lung capacity. Deep breathing exercise also
plays a role in lowering blood pressure and in reducing / relieving anxiety. Studies have
stated that patients who are trained about deep breathing have better exercise status, that
deep breathing exercise have increased systolic and diastolic blood pressure of and anxiety
at statistically significant level. Triflo is a device that helps the patient to breathe
deeply. It is seen as more advantageous in terms of use, as it provides visual information
about the depth of breathing. The use of Triflo is used to support the determination of the
patient's inspiration capacity, normal inspiration and deep breathing.
COVID-19, it has been determined that it improves respiratory function, quality of life and
anxiety of the elderly and has little effect on depression.
The effects of COVID-19 disease on the lung and respiratory system appear to be quite
serious. Since there is not enough information about the long-term results yet, its effect on
patients and lungs after active period is not clearly known. The one of the most important
data the investigators have now is that most of the patients experience dyspnea. In the
literature, there has been no study examining the effect of respiratory exercise on dyspnea,
anxiety and quality of life in patients diagnosed with COVID-19 pneumonia. However, applying
deep breathing exercise with triflo in COVID-19 patients, can contribute to relieving
dyspnea, reducing / eliminating anxiety, reducing / eliminating respiratory system
complications, preserving / improving respiratory function, maintaining or increasing lung
volume, accelerating recovery and increasing quality of life. In the light of this
information, the aim of this study is to determine the effect of deep breathing exercise with
triflo on dyspnea, anxiety and quality of life in patients with dyspnea who are hospitalized
for COVID-19.
MATERIALS AND METHODS This single-centered, randomized controlled study will be held in
Ankara city hospital in Turkey. Ethics committee approval was obtained from Ankara City
Hospital Ethics Committee (Date:12/23/2020 Number:E.Kurul-E1-20-1403). The investigators also
have received permission from the Ministry of Health of the Republic of Turkey for the study
(Date:12/04/2020- Name and number: Hatice ÖNER CENGİZ-2020-12-04T12_09_16). Before the study,
"enlightened informed consent" will be obtained from all participants. The entire study will
be conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010
guidelines and directives.
Data will be collected between January 2021 and March 2021 from 44 patients treated at Ankara
City Hospital COVID-19 clinics.
Randomized block assignment was used to assign 44 patients to the intervention group (n = 22)
and the control group (n = 22). The investigators did block randomization, via a computer
program (sealed envelope, https://www.sealedenvelope.com/ , randomization code:
34780089372265). A randomized block procedure (Vickers, 2006) was performed as follows: (a) a
block size of 4 was selected; (b) subjects were calculated as having eleven conditions (ABBA,
ABBA, BAAB, AABB, BAAB, BABA, AABB, BABA, ABBA, BABA and BAAB); and (c) blocks were randomly
selected to determine the assignment of all 44 participants, with an allocation ratio of 1:1.
The investigators used the G*Power (Version 3.1.9) test to determine the sample size. In the
analysis performed as a priori, The design of the study required a minimum sample size of 44
participants.
The data of the patient will be collected by the researchers by using the Patient
Sociodemographic and Medical Data Form, Dyspnea-12 Scale, Beck Anxiety Inventory and SF-36
Short Form face-to-face and via telephone interviews. During the application of the scales,
all measures will be taken to prevent virus spread.
Sociodemographic and Medical Data Form Sociodemographic and Medical Data Form prepared by the
researchers consists of 14 questions including age, gender, marital status, education level,
body mass index, presence of chronic disease, symptoms due to COVID-19 infection,
experiencing dyspnea, frequency of dyspnea, factors affecting dyspnea, the number of
respirations, oxygen saturation, blood gas analysis results.
Observation indicators:
Primary outcome: Oxygen saturation, respiratory assessment and dyspnea level Secondary
outcomes: Anxiety and quality of life level
1. Oxygen saturation and respiratory rate: The respiratory rate of the patient and oxygen
saturation from the fingertips of the patients will be evaluated by the researchers
using the same pulse oximeter device.
2. Dyspnea: The dyspnea level of the patients will be evaluated with the Dyspnea-12 form.
Dyspnea-12 scale consists of 2 sub-dimensions and a total of 12 items. The Turkish
validity and reliability study of the scale was conducted in 2018, and its Cronbach's
alpha reliability coefficient was found to be 0.97. Permission to use the scale has been
obtained.
3. Anxiety: The anxiety level of the patients will be evaluated with the Beck Anxiety
Inventory. Beck Anxiety Inventory is a scale developed in 1988 and used to determine the
frequency of anxiety symptoms experienced by individuals. The Turkish validity and
reliability study of the scale is available in the book "Clinical Scales Used in
Psychiatry" and is widely used in studies conducted in our country.
4. Life quality: Life quality levels of patients will be evaluated with the World Health
Organization Quality of Life Scale Short Form. The World Health Organization Quality of
Life Scale Short Form is the abbreviation of World Health Organization Quality of Life
Assessment (WHOQOL) scale, which was prepared to evaluate how the individual perceives
the quality of life, consisting of 100-questions and reduced to 26 questions. The scale,
which includes closed-ended questions, consists of four sub-domains: physical, social,
environmental and psychological. The scale does not have a full score, and an increase
in score indicates an improvement in quality of life. The Turkish validity and
reliability study of the scale was conducted in 1999 and the number of questions was
increased to 27 by adding a national question to the scale during their study.
Implementation of the initiative The investigators will include 22 patients in the
intervention group, 22 patients in the control group and with the block randomization method,
starting from the date the study was planned in this study. The investigators will obtain
informed consent from patients who agreed to participate in the study and who meet the
inclusion criteria. The investigators will monitor each patient until they are discharged.
The investigators will exclude patients who were transferred to the intensive care unit or
died during follow-up. All patients included in the study will receive all medical treatment
administered in the hospital.
Interventions group. The investigators will apply a sociodemographic and medical data form,
Dyspnea-12 scale, Beck Anxiety Inventory and SF-36 Short Form to 22 patients included in the
intervention group on the first day of hospitalization. The investigators will give the
triflo device to patients in the intervention group. The investigators will send the training
video The investigators have prepared on how to apply the triflo deep breathing exercise to
the patient's mobile phone to prevent virus spread and The investigators will ask the patient
to do deep breathing with the triflo 5-10 times an hour by watching this video. The
investigators will make the patients do the exercise through video calls, provide information
on whether they are doing it right or not, and answer their questions. After the patients
have breakfast in the morning, they will start their exercises and The investigators will
make them do it 5-10 times an hour until they go to sleep. Until the patients are discharged,
The investigators will evaluate respiratory rate, oxygen saturation with a pulse oximeter
device without oxygen support and make them fill the Dyspnea-12 scale. The investigators will
fill the Dyspnea-12 scale, Beck Anxiety Inventory and SF-36 Short Form while the patients are
discharged.
Control group. The control group will comprise 22 patients treated for COVID-19 pneumonia at
the hospital where the study was conducted. The investigatorswill make these patients fill
the Sociodemographic and medical data form, Dyspnea-12 scale, Beck Anxiety Inventory and
SF-36 Short Form at the beginning of the study; Dyspnea-12 scale every day until discharge ;
the Dyspnea-12 scale, Beck Anxiety Inventory, and SF-36 Short Form during discharge.
Data will be evaluated with Statistical Package for Social Sciences 25 (SPSS) program using
tests suitable for the distribution of data.
