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Stigma, SocialNCT04900389

The Effect of Nurses' Having COVID-19 on Their Professional Lives

An observational study of Stigma, Social and Anxiety, run by Uludag University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Since the first day of the epidemic, people diagnosed with COVID-19 and their relatives, some countries and groups such as healthcare professionals are exposed to discriminatory behavior and stigmatization in the world. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stigma, Social, Anxiety
How many people
354 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2021to 15 Oct 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The universe of work T.C. Nurses working at Ministry of Health Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital Internal and Surgical Clinics (N: 756). The sample calculation of the study was calculated using the sampling method with known universe. The minimum number of people required in the sample was calculated as (n) 354 when 1% error and 99% confidence interval were taken with the Raosoft sampling method. Reaching the total number of nurses selected from internal and surgical clinics by using simple random sampling method.

Who may be able to join

  • T.R. Working as a Clinical (Internal and Surgical) Nurse at the Ministry of Health Health Sciences University Bursa High Specialization Training and Research Hospital,
  • Agreeing to participate in the research voluntarily,
  • Not having any visual, auditory and psychological problems that would hinder conducting surveys and scales,
  • Be 18 years or older,
  • At least high school graduate.

Who cannot join

  • T.R. Not working as a Clinical (Internal and Surgical) Nurse at the Ministry of Health Health Sciences University Bursa High Specialization Training and Research Hospital,
  • Refusing to voluntarily participate in the research,
  • Having any visual, auditory and psychological problems that prevent making surveys and scales,
  • Being under the age of 18,
  • Not having at least a high school graduate.

Trial locations and contacts

1 site in 1 country.

Aysel Özdemir, PhD contact

0-224-294 24 72

ayozdemir@uludag.edu.tr

Turkey (Türkiye)1 site
  • Bursa Uludag University Faculty of Health Sciences

    Bursa, 16000

    Aysel Özdemir, PhD, +9 0-224-294 24 72, ayozdemir@uludag.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Stigma, Anxiety and Wise Awareness Levels on Their Professional Lives With Respect to The Nurses' COVID-19 Status

Background: Since the first day of the epidemic, people diagnosed with COVID-19 and their relatives, some countries and groups such as healthcare professionals are exposed to discriminatory behavior and stigmatization in the world. Nurses fighting in the front lines from the very beginning of the epidemic and interacting with the patient the most experience anxiety and are exposed to stigma.

Aim: With this study, it was aimed to determine the stigma, anxiety and wise awareness levels of nurses in our country according to their COVID-19 experience and to determine their effect on their professional lives.

Methods: The universe of this case-control study, which will determine the level of stigma, anxiety and wise awareness of those who work as nurses in the clinic according to their COVID-19 passing status, is the universe of T.C. Nurses working at Ministry of Health Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital Internal and Surgical Clinics (N: 756). The sample calculation of the research was calculated using the sampling method with known universe. The minimum number of people in the sample was calculated as (n) 354 when 1% error and 99% confidence interval were taken with the Raosoft sampling method. It was planned to reach the total number of nurses selected from internal and surgical clinics by using simple random sampling method and to collect data from these clinics between 15.05.2021 - 15.06.2021. In this study, socio-demographic information and questions about COVID-19, the Effect of COVID-19 Pandemic on Professional Life, "Coronavirus Anxiety Scale" and Toronto Wisdom Awareness Scale will be used in this study.

Read the detailed description

Study Protocol, Methods and Procedures to be Applied The universe of this case-control study, which will determine the level of stigma, anxiety and wise awareness of those who work as nurses in the clinic according to their COVID-19 passing status, is the universe of T.C. Nurses working at Ministry of Health Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital Internal and Surgical Clinics (N: 756). The sample calculation of the research was calculated using the sampling method with known universe. The minimum number of people in the sample was calculated as (n) 354 when 1% error and 99% confidence interval were taken with the Raosoft sampling method. It was planned to reach the total number of nurses selected from internal and surgical clinics by using simple random sampling method and to collect data from these clinics between 15.05.2021 - 15.06.2021. In this study, socio-demographic information and questions about COVID-19, the Effect of COVID-19 Pandemic on Professional Life, "Coronavirus Anxiety Scale" and Toronto Wisdom Awareness Scale will be used in this study. The part containing sociodemographic information is 11 questions. The section on COVID-19 is composed of 11 questions by literature review. The part of the effect of the COVID-19 Pandemic process on professional life is composed of 11 items (Participants will give points between 0 and 10 for the 1st, 2nd, 3rd and 9th items, 0: none, 10: quite often), (4th, 5th, Participants will score between 0 and 10 for the 6th, 7th, 8th, 10th and 11th items, 0: not at all, 10: quite a lot). Each item of the Coronavirus Anxiety Scale (CAS) is rated on a 5-point scale from 0 (not at all) to 4 (almost daily) based on experience over the past two weeks. A CAS total score of 9 indicates dysfunctional anxiety associated with coronavirus. High scores on a particular item or a high total scale score (9) may indicate problematic symptoms of the participant that may require further evaluation and / or treatment. Toronto Wisdom Awareness Scale (DPSS) consists of 13 items and a 5-Likert-type interval is used for each item (1: strongly disagree, 5: strongly agree). Scoring of the scale will be made according to the name of the factor. Scoring will be done in two separate groups as monitoring without being affected (Items 1, 2, 4, 7, 8, 9, 11) and Curiosity (Items 3, 5, 6, 10, 12, 13). Permission was obtained from the responsible authors who made the validity and reliability of the scales to be used in our study. The survey was conducted by researcher, T.C. The Ministry of Health Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital will be held with nurses working in internal and surgical clinics. Due to the COVID-19 pandemic, the questionnaire form will be given to the nurses working in the clinic for application and will be taken back after a certain period of time. The Coronavirus Anxiety Scale and Toronto Wisdom Awareness Scale will also be included in the continuation of the questionnaire. Participants will score 5 items in CAS from 0 (not at all) to 4 (almost every day). Participants will give points to the items in the TBFÖ as 1: absolutely disagree, 2: disagree, 3: undecided, 4: agree, 5: absolutely agree. The total time is 10 minutes.

Keywords
Stigma, Anxiety, Wise awareness, COVID-19, Nurse
Medical subject headings
Social Stigma, Anxiety Disorders, COVID-19

What participants receive

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

Study groups in NCT04900389
Study groupRoleWhat they receive
Case Group: Nurses with COVID-19The questionnaire form is included in the section on COVID-19. 2nd question; They will mark the answer "Yes" to the question "Have you been diagnosed with COVID-19?" 5th question; Individuals who answer "No" to the question "Have you been subjected to discriminatory behaviors by your environment because you were a healthcare worker during the COVID-19 pandemic process?" Will move on to the 11th question in the same section.
Kontrol Group: Nurses who have not had COVID-19The questionnaire form is included in the section on COVID-19. 2nd question; They will mark "No" to the question "Have you been diagnosed with COVID-19?" And move on to the 4th question in the same section. The 5th question in Annex 2 of the questionnaire form; Individuals who answer "No" to the question "Have you been subjected to discriminatory behaviors by your environment because you were a healthcare worker during the COVID-19 pandemic process?" Will move on to the 11th question in the same section.

What is being measured

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

  1. Anxiety levels of nurses according to their COVID-19 passing status

    The Coronavirus Anxiety Scale (CAS) will be used. Each item of CAS is rated on a 5-point scale from 0 (not at all) to 4 (almost daily) based on experience over the past two weeks. A CAS total score of 9 indicates dysfunctional anxiety associated with coronavirus. High scores on a particular item or a high total scale score (9) may indicate problematic symptoms of the individual that may require further evaluation and / or treatment.

    Measured: 5 months

Secondary outcomes (1)
  1. Wise awareness levels of nurses based on their COVID-19 passing status

    The Toronto Wisdom Awareness Scale (PACS) will be used. The scale consists of 13 items in total and a 5-point Likert type range is used for each item (1: strongly disagree, 5: absolutely agree). Scoring of the scale will be made according to the name of the factor. Scoring will be done in two separate groups as monitoring without being affected (Items 1, 2, 4, 7, 8, 9, 11) and Curiosity (Items 3, 5, 6, 10, 12, 13).

    Measured: 5 months

Timeline

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

  1. First posted25 May 2021
  2. Study start15 May 2021 (estimated)
  3. Primary completion15 Oct 2021 (estimated)
  4. Study completion15 Oct 2021 (estimated)

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
Case-control
Time perspective
Prospective
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900389
Sponsor's protocol ID
2021-4/49
Status last verified
May 2021
First submitted
14 May 2021
Last updated
25 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stigma, Social and Anxiety, run by Uludag University at 1 site in Turkey (Türkiye).

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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 May 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 Turkey (Türkiye). 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?

Results are not available in the source record.

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

Contact Aysel Özdemir, PhD (0-224-294 24 72, ayozdemir@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety levels of nurses according to their COVID-19 passing status (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 May 2021.

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