Healthy AdultsNCT04910932
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
A study testing Breathing Exercises and Information on COVID-19 in people with Healthy Adults, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Breathing Exercises and Information on COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteering to participate in the study
- having a smart phone that can be used for teleconferencing purposes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University, Department of Physiotherapy and Rehabilitation
Kayseri
About this study
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.
- Conditions
- Healthy Adults
- Being tested
- Breathing Exercises, Information on COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExercisesOther
Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises
Information on COVID-19Other
Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercises group | Experimental | 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. Receives: Other: Breathing Exercises; Other: Information on COVID-19 |
| Control group | Other | Individuals will be informed about COVID-19 for once at baseline. Receives: Other: Information on COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 2nd, 3rd and 4th week
Secondary outcomes (3)
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.
Measured: Change from baseline at 2nd, 3rd and 4th week
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.
Measured: Change from baseline at 4th week
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).
Measured: Change from baseline at 2nd, 3rd and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start10 Jun 2021
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Nuh Naci Yazgan University
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910932
- Sponsor's protocol ID
- bakircaymzeren04
- Status last verified
- Feb 2022
- First submitted
- 1 Jun 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35467962
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04910932
- Acronym / sponsor ID
- bakircaymzeren04
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Nuh Naci Yazgan University
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises group | Experimental | Other: Breathing Exercises, Other: Information on COVID-19Breathing 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. |
| Control group | Other | Other: Information on COVID-19Individuals will be informed about COVID-19 for once at baseline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- volunteering to participate in the study
- having a smart phone that can be used for teleconferencing purposes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExercisesBreathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises | Other | Breathing Exercises group |
| Information on COVID-19Information about COVID-19 based on the advices in "COVID-19 advice for the public" section of World Health Organization website. | Other | Breathing Exercises group, Control group |
Primary outcome
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.
3 secondary outcomes
Anxiety
Time frame: Change from baseline at 2nd, 3rd and 4th week
Sleep quality
Time frame: Change from baseline at 4th week
Health-related quality of life
Time frame: Change from baseline at 2nd, 3rd and 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 35467962Kepenek-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises and Information on COVID-19 in people with Healthy Adults, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of COVID-19 (time frame: Change from baseline at 2nd, 3rd and 4th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.