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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453566
Other study ID # 61351342/ 2020-286
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 27, 2020
Est. completion date August 24, 2020

Study information

Verified date April 2021
Source Uskudar University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date August 24, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

Other:
Online Survey
Online Survey

Locations

Country Name City State
Turkey Uskudar University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Uskudar University New York Medical College

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at inclusion
Primary 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). one week
Primary 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. at inclusion
Primary 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. one month
Primary 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. at inclusion
Primary 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. at inclusion
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