<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453566</url>
  </required_header>
  <id_info>
    <org_study_id>61351342/ 2020-286</org_study_id>
    <nct_id>NCT04453566</nct_id>
  </id_info>
  <brief_title>Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.</brief_title>
  <official_title>Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uskudar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uskudar University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction&#xD;
      measures among elite athletes during COVID-19 and measure the relationship between these&#xD;
      measures and the changes in training characteristics in elite athletes during the COVID-19&#xD;
      pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 11 March 2020, the World Health Organization declared the COVID-19 outbreak as a pandemic.&#xD;
      On the same day, the first COVID-19 case reported in Turkey and nationwide quarantine&#xD;
      regulations started after a spike in case numbers. In the world of sports, the effects of the&#xD;
      COVID-19 pandemic started with staging games without spectators, gradually all sports events&#xD;
      and team practices were postponed. Soon later, athletes advised to quarantine at home and&#xD;
      continue training individually. Similar to previous study results, the COVID-19 outbreak&#xD;
      expected to cause a profound and wide range of psychosocial impacts on people during&#xD;
      outbreaks of infection. In fact, preliminary results from a study in China showed a moderate&#xD;
      to severe degree psychological impact on more than half of the respondents. However, the&#xD;
      effect of COVID-19 on mental health symptoms in elite athletes has not been investigated.&#xD;
&#xD;
      In this study, the investigator aims to investigate stress, anxiety, mood, life satisfaction&#xD;
      measures among elite athletes during COVID-19 and explore the potential relationship between&#xD;
      these measures and the changes in training characteristics during the COVID-19 pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Actual">August 24, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sociodemographic information and training characteristics</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Beck Anxiety Inventory (BAI)</measure>
    <time_frame>one week</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Visual Analogue Scale (VAS)</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>one month</time_frame>
    <description>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 &amp; 4 = 0) to the four positively stated items (items 4, 5, 7, &amp; 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>at inclusion</time_frame>
    <description>The Satisfaction with Life Scale (Diener, Emmons, Larsen, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brunel mood scale (BRUMS)</measure>
    <time_frame>at inclusion</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">208</enrollment>
  <condition>COVID-19</condition>
  <condition>Life Satisfaction</condition>
  <condition>Anxiety</condition>
  <condition>Mental Health Wellness 1</condition>
  <condition>Athlete</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Elite Athletes</arm_group_label>
    <description>Elite Athletes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online Survey</intervention_name>
    <description>Online Survey</description>
    <arm_group_label>Elite Athletes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elite Athletes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elite Athletes between age of 18-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Athletes with history of COVID-19 disease&#xD;
&#xD;
          -  Athetes with first-degree family members who have/had the COVID-19 disease&#xD;
&#xD;
          -  Athletes with non-covid related injuries restraining from physical activity&#xD;
&#xD;
          -  History of psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mesut Karahan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uskudar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uskudar University</name>
      <address>
        <city>Istanbul</city>
        <zip>34662</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uskudar University</investigator_affiliation>
    <investigator_full_name>Ihsan Balkaya</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Athlete</keyword>
  <keyword>Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453566
org study id: 61351342/ 2020-286
nct id: NCT04453566
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Retrospective
measure: Sociodemographic information and training characteristics
time frame: at inclusion
description: 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.
measure: The Beck Anxiety Inventory (BAI)
time frame: one week
description: 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).
measure: The Visual Analogue Scale (VAS)
time frame: at inclusion
description: 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.
measure: Perceived Stress Scale (PSS)
time frame: one month
description: 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.
measure: Satisfaction with Life Scale
time frame: at inclusion
description: 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.
measure: Brunel mood scale (BRUMS)
time frame: at inclusion
description: 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.
arm group label: Elite Athletes
description: Elite Athletes
intervention type: Other
intervention name: Online Survey
description: Online Survey
arm group label: Elite Athletes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mesut Karahan, PhD
role: Principal Investigator
affiliation: Uskudar University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Uskudar University
investigator full name: Ihsan Balkaya
investigator title: Medical Doctor
mesh term: COVID-19
mesh term: Anxiety Disorders