NCT04453566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2020

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

June 29, 2020

Last Update Submit

April 28, 2021

Conditions

Keywords

COVID-19AthleteMental Health

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Elite Athletes

Elite Athletes

Other: Online Survey

Interventions

Online Survey

Elite Athletes

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Elite Athletes

You may qualify if:

  • Elite Athletes between age of 18-35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Personal SatisfactionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehaviorMental Disorders

Study Officials

  • Mesut Karahan, PhD

    Uskudar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 1, 2020

Study Start

May 27, 2020

Primary Completion

August 15, 2020

Study Completion

August 24, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations