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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04769284
Other study ID # Mental health student
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 12, 2021
Est. completion date February 21, 2021

Study information

Verified date February 2021
Source Instituto de Investigación Sanitaria Aragón
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

University students report high levels of stress, anxiety and depression every year, which, according to some research, responsible for university administration and popular media, constitutes a global crisis of mental health of students at these levels. Exposure to academic stress directly compromises students' motivation and attitudes towards learning. High levels of perceived distress in the face of inadequate resources to deal with the situation leaves people at risk of developing major psychiatric problems, especially when this distress is prolonged or severe.


Description:

Main goal:Study the impact of socio-demographic, personal and health factors that determine the performance / perception of pandemic stress) in students of Bachelor's degrees in Health Sciences. Secondary objectives: - Analyze the relationship between socio-demographic and personal characteristics and the perception of stress related to the Covid-19 pandemic. - Identify the relationship between the perception of stress related to the Covid-19 pandemic and the role of gender / physical activity and the academic performance of undergraduate students in Health Sciences. Methodology All variables will be obtained only once by means of a survey through google form. The questionnaire will be disseminated to all students of the degrees, by institutional email, through direct contact with the delegates of each course. After the first two weeks, a reminder will be made following the same routes. There will be no follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 332
Est. completion date February 21, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Students of the degree of nursing, occupational therapy and physiotherapy belonging to the Faculty of Health Sciences Exclusion Criteria: - Not belonging to any degree in Health Sciences of the Faculty of Health Sciences

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mental health student
An ad-hoc questionnaire was designed that included sociodemographic variables related to the characteristics of the students. The variables sex, age, degree, employment situation, coexistence situation, economic situation, origin environment, country of origin, time of residence in the Spanish State were collected. Personal variables: Gender stereotypes: Short version of the Bem Sex Rol Inventory (BRSI). International Physical Activity Questionnaire (IPAQ) Abbreviated Goldberg Anxiety Scale EADG Modified version of EPP-10 related to COVID-19 (EPP-10-C)

Locations

Country Name City State
Spain Faculty of Health Sciences. Zaragoza's University Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Yolanda Marcen Roman Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scopin — View Citation

Bao Y, Sun Y, Meng S, Shi J, Lu L. 2019-nCoV epidemic: address mental health care to empower society. Lancet. 2020 Feb 22;395(10224):e37-e38. doi: 10.1016/S0140-6736(20)30309-3. Epub 2020 Feb 7. — View Citation

Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 — View Citation

Odriozola-González P, Planchuelo-Gómez Á, Irurtia MJ, de Luis-García R. Psychological symptoms of the outbreak of the COVID-19 confinement in Spain. J Health Psychol. 2020 Oct 30:1359105320967086. doi: 10.1177/1359105320967086. [Epub ahead of print] — View Citation

Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. Review. — View Citation

Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 29;:. — View Citation

Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Sociodemographic variables An ad-hoc questionnaire was designed that included sociodemographic variables related to the characteristics of the students. The variables sex, age, qualification, employment situation, coexistence situation, economic situation, origin environment, country of origin were collected. 4 minutes
Primary Modified version of EPP-10 related to COVID-19 (EPP-10-C) EEP-10-C; modified version of the 10-item perceived stress scale (EEP-10), it is also composed of 10 items; each offers 5 response options: never, almost never, occasionally, almost always, and always. Items 1, 2, 3, 6, 9 and 10 are scored directly from 0 to 4 and items 4, 5, 7 and 8, conversely, from 4 to 0 3 minutes
Primary Abbreviated Goldberg Anxiety Scale EADG It examines four fundamental psychiatric areas: depression, anxiety, social inadequacy, and hypochondria. It contains 9 questions and the cut-off points are equal to or greater than 4 for the anxiety scale, and equal to or greater than 2 for the depression scale. 3 minutes
Secondary Gender stereotypes: Short version of the Bem Sex Rol Inventory (BRSI). The 12-item questionnaire collected 6 instrumental or masculine items (strong personality, acts as a leader, has the character of a leader, dominant personality, defender of their beliefs and makes decisions easily), and 6 expressive or feminine items (tender, gentle, warm, affectionate, understanding and sensitive to the needs of others). People answered each of the questions about their self-perception, using a 7-point Likert-type scale 4 minutes
Secondary Short International Physical Activity Questionnaire (IPAQ) The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) carried out in the last seven days, as well as walking and sitting time in a work day.
Reference Mets values are: walking 3.3 Mets, moderate physical activity: 4 Mets, vigorous physical activity: 8 Mets.
4 minutes
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