AzTrials
AzTrials

Stress, PsychologicalNCT04769284

Psychological State of Students of Health Sciences During COVID-19

An observational study of Stress, Psychological and Anxiety, run by Yolanda Marcen Roman at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Stress, Psychological, Anxiety, Depression
What is being tested?
Mental health student
How many people
332 participants
Where
1 siteSpain
Study dates
12 Feb 2021to 21 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study population will be made up of nursing, physiotherapy and occupational therapy students from the Faculty of Health Sciences of Zaragoza. Students will be able to answer the questions through their electronic devices. At no time will it be known which student has responded since he is totally anonymous and voluntary.

Who may be able to join

  • Students of the degree of nursing, occupational therapy and physiotherapy belonging to the Faculty of Health Sciences

Who cannot join

  • Not belonging to any degree in Health Sciences of the Faculty of Health Sciences

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Health Sciences. Zaragoza's University

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Psychological State of University Students of Health Sciences During COVID-19

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.

Read the detailed 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.

Being tested
Mental health student
Keywords
university students, physical activity, gender stereotype
Medical subject headings
Stress, Psychological, Anxiety Disorders, Depression, COVID-19, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental health studentOther

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 minutes

  2. 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.

    Measured: 3 minutes

Secondary outcomes (2)

  1. 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

    Measured: 4 minutes

  2. 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.

    Measured: 4 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start12 Feb 2021
  3. Primary completion20 Feb 2021
  4. Study completion21 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04769284
Sponsor's protocol ID
Mental health student
Status last verified
Feb 2021
First submitted
23 Feb 2021
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The study design could be reported

Publications

  • 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. No abstract available.

    PubMed 32043982

  • 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. No abstract available.

    PubMed 31986257

  • Odriozola-Gonzalez P, Planchuelo-Gomez A, Irurtia MJ, de Luis-Garcia R. Psychological symptoms of the outbreak of the COVID-19 confinement in Spain. J Health Psychol. 2022 Mar;27(4):825-835. doi: 10.1177/1359105320967086. Epub 2020 Oct 30.

    PubMed 33124471

  • 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.

    PubMed 32113704

  • 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 scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.

    PubMed 32183901

  • 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 Feb 26.

    PubMed 32112714

  • 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. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.

    PubMed 32155789

Questions about this trial

What is this clinical trial studying?

An observational study of Stress, Psychological and Anxiety, run by Yolanda Marcen Roman at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified version of EPP-10 related to COVID-19 (EPP-10-C) (time frame: 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04769284, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in