COVID-19NCT04453566
Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.
An observational study of COVID-19 and Life Satisfaction, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Life Satisfaction, Anxiety
- What is being tested?
- Online Survey
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2020to 24 Aug 2020
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Elite Athletes
Who may be able to join
- Elite Athletes between age of 18-35
Who cannot join
- Athletes with history of COVID-19 disease
- Athetes with first-degree family members who have/had the COVID-19 disease
- Athletes with non-covid related injuries restraining from physical activity
- History of psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic.
Read the detailed description
On 11 March 2020, the World Health Organization declared the COVID-19 outbreak as a pandemic. On the same day, the first COVID-19 case reported in Turkey and nationwide quarantine regulations started after a spike in case numbers. In the world of sports, the effects of the COVID-19 pandemic started with staging games without spectators, gradually all sports events and team practices were postponed. Soon later, athletes advised to quarantine at home and continue training individually. Similar to previous study results, the COVID-19 outbreak expected to cause a profound and wide range of psychosocial impacts on people during outbreaks of infection. In fact, preliminary results from a study in China showed a moderate to severe degree psychological impact on more than half of the respondents. However, the effect of COVID-19 on mental health symptoms in elite athletes has not been investigated.
In this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and explore the potential relationship between these measures and the changes in training characteristics during the COVID-19 pandemic.
- Conditions
- COVID-19, Life Satisfaction, Anxiety, Mental Health Wellness 1, Athlete, Stress
- Being tested
- Online Survey
- Keywords
- COVID-19, Athlete, Mental Health
- Medical subject headings
- COVID-19, Personal Satisfaction, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyOther
Online Survey
| Study group | Role | What they receive |
|---|---|---|
| Elite Athletes | Elite Athletes Receives: Other: Online Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic information and training characteristics
Sociodemographic information and training characteristics Participants asked to provide sociodemographic information. Also, the difference in training frequency, duration, and quality after COVID-19 pandemic measured via 22 self-created questions.
Measured: at inclusion
The Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (Beck et al., 1988) has been widely used to measure the severity of anxiety by self-report and showed to has internal consistency and high test-retest reliability. The Turkish version of the BAI proved to be a reliable and valid measure (Ulusoy et al., 1993). The participant rates how much each symptom has bothered the participant in the past week in the 21-item self-report questionnaire. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (4).
Measured: one week
The Visual Analogue Scale (VAS)
The Visual Analogue Scale (0 not stressed at all - 10 maximum amount of stress) used to measure self-reported stress and anxiety in elite athletes before and during the COVID-19 pandemic. The VAS showed to be an efficient tool for assessing self-reported stress and anxiety.
Measured: at inclusion
Perceived Stress Scale (PSS)
The 14-item version of PSS scale asks patients how often they had experienced thoughts and feelings such as control irritations and stress during the previous one month, with responses ranging from 0 (never) to 4 (very often). The Turkish PSS proved to be a reliable and valid tool to measure perceived stress. The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.
Measured: one month
Satisfaction with Life Scale
The Satisfaction with Life Scale (Diener, Emmons, Larsen, \& Griffin, 1985) is a 5-item measure designed to measure global cognitive judgments of one's life satisfaction. The answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.
Measured: at inclusion
Brunel mood scale (BRUMS)
The BRUMs scale is based on the Profile of Mood States. The Turkish version of the BRUMS scale studied on Turkish athletes, 24-item measures and six subscales in the original version decreased to 19 items and four subscales: anger, depression, vigor, fatigue. The results of the study proved to be valid and reliable (Cakiroglu et al., 2016). Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within the subscale are summed and a score range from 0 to 16.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start27 May 2020
- Primary completion15 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Medical College
- Responsible party
- Principal investigator, Ihsan Balkaya, Uskudar University
- Investigators
- Mesut Karahan, PhD, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453566
- Sponsor's protocol ID
- 61351342/ 2020-286
- Status last verified
- Apr 2021
- First submitted
- 29 Jun 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.
- ClinicalTrials.gov ID
- NCT04453566
- Acronym / sponsor ID
- 61351342/ 2020-286
- Conditions
- COVID-19, Life Satisfaction, Anxiety, Mental Health Wellness 1, Athlete, Stress
- Keywords
- COVID-19, Athlete, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- New York Medical College
- Study start
- 27 May 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 1 Jul 2020 (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.
In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic.
Detailed description
On 11 March 2020, the World Health Organization declared the COVID-19 outbreak as a pandemic. On the same day, the first COVID-19 case reported in Turkey and nationwide quarantine regulations started after a spike in case numbers. In the world of sports, the effects of the COVID-19 pandemic started with staging games without spectators, gradually all sports events and team practices were postponed. Soon later, athletes advised to quarantine at home and continue training individually. Similar to previous study results, the COVID-19 outbreak expected to cause a profound and wide range of psychosocial impacts on people during outbreaks of infection. In fact, preliminary results from a study in China showed a moderate to severe degree psychological impact on more than half of the respondents. However, the effect of COVID-19 on mental health symptoms in elite athletes has not been investigated.
In this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and explore the potential relationship between these measures and the changes in training characteristics during the COVID-19 pandemic.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elite Athletes | – | Other: Online SurveyElite Athletes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Elite Athletes
Key inclusion criteria (1 listed)
- Elite Athletes between age of 18-35
Key exclusion criteria (4 listed)
- Athletes with history of COVID-19 disease
- Athetes with first-degree family members who have/had the COVID-19 disease
- Athletes with non-covid related injuries restraining from physical activity
- History of psychiatric disease
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 |
|---|---|---|
| Online SurveyOnline Survey | Other | Elite Athletes |
Primary outcome
Sociodemographic information and training characteristics
Time frame: at inclusion
Sociodemographic information and training characteristics Participants asked to provide sociodemographic information. Also, the difference in training frequency, duration, and quality after COVID-19 pandemic measured via 22 self-created questions.
The Beck Anxiety Inventory (BAI)
Time frame: one week
The Beck Anxiety Inventory (Beck et al., 1988) has been widely used to measure the severity of anxiety by self-report and showed to has internal consistency and high test-retest reliability. The Turkish version of the BAI proved to be a reliable and valid measure (Ulusoy et al., 1993). The participant rates how much each symptom has bothered the participant in the past week in the 21-item self-report questionnaire. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (4).
The Visual Analogue Scale (VAS)
Time frame: at inclusion
The Visual Analogue Scale (0 not stressed at all - 10 maximum amount of stress) used to measure self-reported stress and anxiety in elite athletes before and during the COVID-19 pandemic. The VAS showed to be an efficient tool for assessing self-reported stress and anxiety.
Perceived Stress Scale (PSS)
Time frame: one month
The 14-item version of PSS scale asks patients how often they had experienced thoughts and feelings such as control irritations and stress during the previous one month, with responses ranging from 0 (never) to 4 (very often). The Turkish PSS proved to be a reliable and valid tool to measure perceived stress. The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.
Satisfaction with Life Scale
Time frame: at inclusion
The Satisfaction with Life Scale (Diener, Emmons, Larsen, \& Griffin, 1985) is a 5-item measure designed to measure global cognitive judgments of one's life satisfaction. The answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.
Brunel mood scale (BRUMS)
Time frame: at inclusion
The BRUMs scale is based on the Profile of Mood States. The Turkish version of the BRUMS scale studied on Turkish athletes, 24-item measures and six subscales in the original version decreased to 19 items and four subscales: anger, depression, vigor, fatigue. The results of the study proved to be valid and reliable (Cakiroglu et al., 2016). Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within the subscale are summed and a score range from 0 to 16.
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 30 Apr 2021.
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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.
Mesut Karahan, PhD principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Life Satisfaction, run by Uskudar 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 1 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 30 Apr 2021. 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?
Sociodemographic information and training characteristics (time frame: at inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2021.