The Effect of Deep Breathing Exercise on Dyspnea, Anxiety and Quality of Life in Patients Treated for COVID-19

NCT04696562 | Completed

• 1 other identifier: OCengiz
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; Breathing Exercises; Dyspnea; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Oxygen saturation (%)

  Oxygen saturation (%) The oxygen saturation of the patient from the fingertips of the patients will be evaluated by the researchers using the same pulse oximeter device everyday.

  until the treatment is completed,an average of 7 days

• Respiratory rate per minute

  The respiratory rate of the patient will be evaluated by the researchers every day by counting the respiratory rate per minute.

  until the treatment is completed,an average of 7 days

• Dyspnea level

  The dyspnea level of the patients will be evaluated with the Dyspnea-12 form.Dyspnea-12 scale is a scale that measures the severity of dyspnea (shortness of breath) and consists of 2 sub-dimensions and a total of 12 items.

  until the treatment is completed,an average of 7 days

Secondary Outcomes (2)

• Anxiety

  post-treatment change (one week change)

• Quality of life level

  post-treatment change (one week change)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group is the group in which the investigors applied deep breathing exercises with triflo.

Behavioral: Deep Breathing Exercise with Triflo

Control group

NO INTERVENTION

The control group is the group that receives standard clinical care.

Interventions

Deep Breathing Exercise with Triflo BEHAVIORAL

The investigators will do deep breathing exercises 5-10 times an hour with the triflo device.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients,
• who are in clinical treatment for COVID-19 pneumonia;
• who are 18 years of age or older, mentally healthy;
• who can speak and understand Turkish;
• who owns and can use smartphones;
• who suffer from dyspnea,
• who do not have chronic diseases related to the respiratory system (lung diseases, heart diseases, etc.);
• who are volunteers, will be included in the study.

You may not qualify if:

• The Patients
• for whom the data required for the study could not be collected;
• who are unable to complete the work (not wanting to continue working, transferred to the intensive care unit and died);
• who do not agree to participate in the study, will be excluded.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Hatice ÖNER CENGİZ

Altındağ, Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Oner Cengiz H, Ayhan M, Guner R. Effect of deep breathing exercise with Triflo on dyspnoea, anxiety and quality of life in patients receiving covid-19 treatment: A randomized controlled trial. J Clin Nurs. 2022 Dec;31(23-24):3439-3453. doi: 10.1111/jocn.16171. Epub 2021 Dec 12.

  PMID: 34897869 DERIVED

MeSH Terms

Conditions

COVID-19; Dyspnea; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hatice ÖNER CENGİZ

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer PhD.

Model Details: This single-centered, randomized controlled study will be held in Ankara city hospital in Turkey. The investigators used the G\*Power (Version 3.1.9) test to determine the sample size. Participants included patients who treated in hospital for covid-19 who fulfilled the inclusion criteria and agreed to participate. 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).

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 6, 2021
• Study Start: January 11, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)