Status Approved
First Submitted Date
2021/02/04
Registered Date
2021/02/18
Last Updated Date
2021/02/04
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005907 |
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Unique Protocol ID | 7001355-202101-HR-415 |
Public/Brief Title | The relationship between job stress and resilience of nursing hospital nurses in the COVID-19 situation |
Scientific Title | The relationship between job stress and resilience of nursing hospital nurses in the COVID-19 situation: Mediating Effects of Nursing Professional Intuition and Organizational Communication |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 7001355-202101-HR-415 |
Approval Date | 2021-01-28 |
Institutional Review Board Name | Konkuk University Institutional Review Board |
Institutional Review Board Address | 120, Neungdong-ro, Gwangjin-gu, Seoul |
Institutional Review Board Telephone | 02-2049-6289 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Bommi Park |
Title | Dr. |
Telephone | +82-43-840-3960 |
Affiliation | Konkuk University |
Address | 268, Chungwon-daero, Chungju-si, Chungcheongbuk-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Jiyeon Jung |
Title | Dr. |
Telephone | +82-2-3290-4751 |
Affiliation | Korea University |
Address | 145, Anam-ro, Seongbuk-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Jiyeon Jung |
Title | Dr. |
Telephone | +82-2-3290-4751 |
Affiliation | Korea University |
Address | 145, Anam-ro, Seongbuk-gu, Seoul, Republic of Korea |
4. Status
Study Site | Multi-center Number of center : 6 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 Actual | |
Target Number of Participant | 230 | |
Primary Completion Date | 2021-02-22 , Anticipated | |
Study Completion Date | 2022-01-27 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Seocho Cham Convalescence Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Songpa Cham Senior Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Seongbuk Cham Convalescence Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | Gangnam-gu Haengbok Convalescence Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | Cham Senior Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Seoul Silverlight Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-01-29 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Konkuk University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Konkuk University |
Organization Type | University |
7. Study Summary
Lay Summary | COVID-19 is a rapidly spreading and prevalent respiratory disease worldwide. Healthcare professionals who are in close contact with COVID-19 patients experience mental health problems such as stress, depression, anxiety, post-traumatic stress disorder, and exhaustion. Simultaneously, the number of older adults aged 65 and over is predicted to increase rapidly from about 6.67 million in 2016 (13.5% of the total population) to about 12.95 million in 2030 (24.5% of the total population) in Korea. The number of nursing hospitals more than doubled from 670 in 2008 to 1.529 in 2017 due to increased demand. In such a problematic situation, nurses are at the forefront of infectious diseases and are experiencing significant difficulties. Policies and systems are required to overcome fatigue and exhaustion caused by excessive workload, stress, fear of infection. Therefore, in this study, by looking at the effects of nursing professional intuition and organizational communication on resilience as a mediating effect of nursing hospital nurses' job stress, intervention studies, systems, and interventional studies on mediating effects that can reduce nurses' job stress and increase resilience. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Cross-sectional |
Target Number of Participant | 230 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Nursing hospital nurses |
Cohort/Group Description Nurses working at 6 nursing hospitals in Seoul |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Nurses working at 6 nursing hospitals in Seoul |
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Sampling Method | With the Ministry of Nursing's approval at 6 nursing hospitals located in Seoul, through the recruitment announcement, only those who have interest and interest in this study and wish to participate in this study will use convenient sampling and snowball sampling. |
Condition(s)/Problem(s) |
* (Z00-Z99)Factors influencing health status and contact with health services (Z56.6)Problems related to other physical and mental strain related to work healthcare providers with psychological distress |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~65Year |
|
Description Those who want to participate in research as a nurse in 6 nursing hospitals in Seoul |
|
Exclusion Criteria |
Those with less than 3 months of experience working in nursing hospitals |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Job stress |
|
Timepoint | baseline |
|
Primary Outcome(s) 2 | ||
Outcome | Resilience |
|
Timepoint | baseline |
|
Secondary Outcome(s) 1 | ||
Outcome | Nursing Professional Intuition |
|
Timepoint | baseline |
|
Secondary Outcome(s) 2 | ||
Outcome | Organizational Communication |
|
Timepoint | baseline |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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