- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453566
Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34662
- Uskudar University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elite Athletes between age of 18-35
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elite Athletes
|
Online Survey
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at inclusion
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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).
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one week
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The Visual Analogue Scale (VAS)
Time Frame: at inclusion
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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.
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at inclusion
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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.
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one month
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Satisfaction with Life Scale
Time Frame: at inclusion
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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.
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at inclusion
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Brunel mood scale (BRUMS)
Time Frame: at inclusion
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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.
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at inclusion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mesut Karahan, PhD, Uskudar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61351342/ 2020-286
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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