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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06383286
Other study ID # AnkaraYBUfby
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date March 1, 2022

Study information

Verified date April 2024
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 1, 2022
Est. primary completion date March 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Being a physically disabled athlete - Preparation for the Paralympic Games - Volunteering to participate in the study Exclusion Criteria: - Serious psychiatric illness - Regular use of sedatives or neuropsychiatric drugs - presence of active alcohol or drug addiction - Presence of a systemic or neurological problem that develops independent of disability pathology.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ankara Yildirim Beyazit Univercity Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary State-Trait Anxiety Inventory (STAI) This inventory consists of two subscales(state and trait), each consisting of 20 questions. The state anxiety scale determines how the individual feels at a particular moment and under certain conditions, while the trait anxiety scale determines how the individual feels independent of the situation and conditions he or she is in. 8 months
Primary The Center for Epidemiological Studies Depression Scale (CES-D) The CES-Depression Scale is a short self-report scale developed by the American National Institute of Mental Health to be used in scientific studies to evaluate the depressive symptoms of the general population. The scale has 20 items and asks questions about feelings and thoughts about the past week. 8 months
Primary Fatigue Severity Scale It is used to determine the fatigue status of the participants. The scale consists of 9 items and evaluates the last week. 8 months
Primary International Physical Activity Questionnaire short form The questionnaire, consisting of seven questions, provides information about sitting, walking, moderately activities, and time spent on vigorous activities. The total score is calculated by adding walking, moderate-intensive, vigorous activity, and the duration (minutes) and frequency (days) of these activities 8 months
Primary Perceived Stress Scale (PSS-14) Consisting of 14 items, the PSS is designed to measure how stressful certain situations in a person's life are perceived. 8 months
See also
  Status Clinical Trial Phase
Recruiting NCT04748497 - Performance Assessement for Paralympic Athletes N/A