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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910932
• Other study ID #: bakircaymzeren04
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: September 14, 2021

Study information

• Verified date: February 2022
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Healthy Adults

Intervention

Other:
• Breathing Exercises
Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises
• 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.

Locations

Country	Name	City	State
Turkey	Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Nuh Naci Yazgan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 2nd, 3rd and 4th week
Secondary	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.	Change from baseline at 2nd, 3rd and 4th week
Secondary	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.	Change from baseline at 4th week
Secondary	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).	Change from baseline at 2nd, 3rd and 4th week