Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic

February 23, 2022 updated by: Melih Zeren, Izmir Bakircay University
It has been reported that in the first stages of the pandemic, a significant portion of the general population experienced psychological problems such as anxiety, depression and post-traumatic disorders. These problems persist today. A balanced diet, physical activity participation and relaxation techniques are recommended for preventing such problems. In studies conducted before the pandemic, it is reported that breathing exercises have positive effects on anxiety, sleep and quality of life in both patients and healthy individuals. Aim of this study is to investigate the effects of breathing exercises applied via teleconference on fear of COVID-19, anxiety, sleep and quality of life in healthy adult population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey
        • Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • volunteering to participate in the study
  • having a smart phone that can be used for teleconferencing purposes

Exclusion Criteria:

  • have had COVID-19
  • hospital admission for suspected COVID-19 in the past week
  • having acute respiratory tract infection
  • having any diagnosed chronic respiratory, cardiovascular, metabolic or neurological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breathing Exercises group
Breathing exercises will be applied via teleconference by a physiotherapist 1 day a week. Individuals will perform exercises by themselves at their homes on the remaining 6 days of the week. Exercise program will be applied for 4 weeks. Individuals will also be informed about COVID-19 for once at baseline.
Other: Breathing Exercises
Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises
Other: Information on COVID-19
Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.
Other: Control group
Individuals will be informed about COVID-19 for once at baseline.
Other: Information on COVID-19
Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of COVID-19
Time Frame: Change from baseline at 2nd, 3rd and 4th week
Fear of COVID-19 will be evaluated using The Fear of COVID-19 scale. The scale consists of seven items, each with a five-point Likert scale of options. The participant is instructed to choose an option that best represents their perception about the statement presented. Higher score indicates higher levels of fear.
Change from baseline at 2nd, 3rd and 4th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Change from baseline at 2nd, 3rd and 4th week
Anxiety will be evaluated using Hamilton Anxiety Rating Scale. Scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Change from baseline at 2nd, 3rd and 4th week
Sleep quality
Time Frame: Change from baseline at 4th week
Sleep quality will be evaluated using The Pittsburgh Sleep Quality Index. Questionnaire assesses sleep quality over a 1-month time interval. It consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Change from baseline at 4th week
Health-related quality of life
Time Frame: Change from baseline at 2nd, 3rd and 4th week
Health-related quality of life will be evaluated using EQ-5D-3L. Questionnaire describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem).
Change from baseline at 2nd, 3rd and 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Collaborators

Nuh Naci Yazgan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

September 14, 2021

Study Completion (Actual)

September 14, 2021

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bakircaymzeren04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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