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).
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.
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
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.
- Conditions
- Stigma, Social, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Case Group: Nurses with COVID-19 | The 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-19 | The 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.
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)
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.
- First posted25 May 2021
- Study start15 May 2021 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze BULUT, Uludag University
- Investigators
- Aysel Özdemir, PhD, Principal investigator, Uludag UniversityGamze Bulut, Master, Study chair, Uludag University
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stigma, Anxiety and Wise Awareness Levels on Their Professional Lives With Respect to The Nurses' COVID-19 Status
- ClinicalTrials.gov ID
- NCT04900389
- Acronym / sponsor ID
- 2021-4/49
- Conditions
- Stigma, Social, Anxiety
- Keywords
- Stigma, Anxiety, Wise awareness, COVID-19, Nurse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group: Nurses with COVID-19 | – | –The 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-19 | – | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety levels of nurses according to their COVID-19 passing status
Time frame: 5 months
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.
1 secondary outcome
Wise awareness levels of nurses based on their COVID-19 passing status
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysel Özdemir, PhD principal investigator
Uludag University
Gamze Bulut, Master study chair
Uludag University
1 site in 1 country: see every site and its status.
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.