Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Primary Purpose
Healthy Adults
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing Exercises
Information on COVID-19
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Adults
Eligibility Criteria
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
Sites / Locations
- Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Breathing Exercises group
Control group
Arm Description
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.
Individuals will be informed about COVID-19 for once at baseline.
Outcomes
Primary Outcome Measures
Fear of COVID-19
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.
Secondary Outcome Measures
Anxiety
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.
Sleep quality
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.
Health-related quality of life
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).
Full Information
NCT ID
NCT04910932
First Posted
June 1, 2021
Last Updated
February 23, 2022
Sponsor
Izmir Bakircay University
Collaborators
Nuh Naci Yazgan University
1. Study Identification
Unique Protocol Identification Number
NCT04910932
Brief Title
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Official Title
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Nuh Naci Yazgan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathing Exercises group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Individuals will be informed about COVID-19 for once at baseline.
Intervention Type
Other
Intervention Name(s)
Breathing Exercises
Intervention Description
Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises
Intervention Type
Other
Intervention Name(s)
Information on COVID-19
Intervention Description
Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.
Primary Outcome Measure Information:
Title
Fear of COVID-19
Description
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.
Time Frame
Change from baseline at 2nd, 3rd and 4th week
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
Change from baseline at 2nd, 3rd and 4th week
Title
Sleep quality
Description
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.
Time Frame
Change from baseline at 4th week
Title
Health-related quality of life
Description
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).
Time Frame
Change from baseline at 2nd, 3rd and 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
City
Kayseri
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
35467962
Citation
Kepenek-Varol B, Zeren M, Dincer R, Erkaya S. Breathing and Relaxation Exercises Help Improving Fear of COVID-19, Anxiety, and Sleep Quality: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jul;28(7):579-586. doi: 10.1089/jicm.2021.0381. Epub 2022 Apr 25.
Results Reference
derived
Learn more about this trial
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
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