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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04926441
Other study ID # COVID_International
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date April 30, 2021

Study information

Verified date June 2021
Source The Opole University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Polish, Slovak and Lithuanian Students.


Description:

The COVID-19 pandemic has had the effect of accelerating changes in educational processes around the world. It resulted in a rapid conversion from face-to-face to online classes. This has disrupted the regular pattern of education and standard practices that have been followed for many years. It is a big organizational challenge for the academics but most importantly for the students. Remote learning has resulted in long-term social isolation and limitations in interaction with peers. It has also been noted that about 30% of students have symptoms of depression and increased levels of perceived stress, which during the COVID-19 pandemic affects about 50% of young people. Many factors have an impact on this condition, besides the epidemic situation, the social mood and the numerous restrictions, the prolonged time spent online and the reduced level of physical activity have an additional negative impact on their mental health. Due to the dynamic situation of the pandemic, there is a lack of current studies on the mental state of young people especially in the context of ongoing e-learning. Therefore, it was decided to investigate what is the prevalence of depressive disorders and the level of perceived stress during the ongoing remote learning in the group of students of 8 European Universities among Poland, Slovakia and Lithuania.


Recruitment information / eligibility

Status Completed
Enrollment 4870
Est. completion date April 30, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - Students attending the course cycle Exclusion Criteria: - Inability to self-complete the research questionnaires; - Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Stress Levels and Mental Well-Being assessment
At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.

Locations

Country Name City State
Lithuania Lithuanian Sports University Kaunas
Poland Jan Dlugosz University in Czestochowa Czestochowa
Poland Faculty of Physical Education and Physiotherapy, Opole University of Technology Opole
Poland The University School of Physical Education in Wroclaw Wroclaw
Slovakia Matej Bel University Banská Bystrica
Slovakia Slovak Medical University in Bratislava Banská Bystrica
Slovakia Technical University of Košice Košice
Slovakia Constantine the Philosopher University in Nitra Nitra

Sponsors (1)

Lead Sponsor Collaborator
The Opole University of Technology

Countries where clinical trial is conducted

Lithuania,  Poland,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perception of Stress Questionnaire (PSQ) The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment. 20 minutes
Primary Beck's Depression Inventory The BDI-II is a tool used to determine the degree of intensity of depressive symp-toms. The 21-item questionnaire consists of two parts: emotional and somatic. Depending on the number of points obtained, the severity of depression can be assessed. A range of 0-10 points indicates no depression, 11-27 indicates moderate mood disorder, and 28 indicates major depressive disorder. The cutoff for dividing patients into depressive and non-depressive subgroups was a score of 10, following the guidelines given by Beck et al. 20 minutes
Primary Authors' survey The survey contains five sections on the impact of e-learning on various aspects of life. The survey responses were structured on a 5-point Likert scale from 1 to 5, where 1 refers to "strongly disagree" statement and 5 to "definitely agree". Questions were grouped into areas: Social life (3 questions), Education skills (4 questions), Eco-nomic field (2 questions), Nutrition habits and drugs (2 questions). The questionnaire showed satisfactory reliability with a Cronbach alpha of 0.82. 10 minutes
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