UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044355 |
|---|---|
| Receipt number | R000050657 |
| Scientific Title | COVID-19 Pandemic Effects on Japanese Nursing Students |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2023/08/01 19:15:34 |
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Basic information
Public title
COVID-19 Pandemic Effects on Japanese Nursing Students
Acronym
COVID-19 Pandemic Effects on Japanese Nursing Students
Scientific Title
COVID-19 Pandemic Effects on Japanese Nursing Students
Scientific Title:Acronym
COVID-19 Pandemic Effects on Japanese Nursing Students
Region
| Japan |
Condition
Condition
Normal subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was to assess the mental health of nursing students under COVID-19 pandemic.
Basic objectives2
Others
Basic objectives -Others
The secondary aim is to investigate the factors associated with the mental health of nursing students during the COVID-19 pandemic.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of GAD-7, PHQ-9, and ISI-7
Key secondary outcomes
Factors associated with GAD-7, PHQ-9, and ISI-7
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Students who have given their consent to participate in this study.
2. Nursing students at a four-year university.
Key exclusion criteria
None
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Kako |
Organization
University of Hyogo
Division name
College of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kitaoji-ho, Akashi, Hyogo
TEL
078-925-9432
jun_kako@cna.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kako |
Organization
University of Hyogo
Division name
College of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kitaoji-ho, Akashi, Hyogo
TEL
078-925-9432
Homepage URL
jun_kako@cna.u-hyogo.ac.jp
Sponsor or person
Institute
College of Nursing Art and Science, University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
College of Nursing Art and Science, University of Hyogo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Hyogo
Address
13-71 Kitaoji-ho, Akashi, Hyogo
Tel
078-925-9432
jun_kako@cna.u-hyogo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立大学（兵庫県）、関西福祉大学（兵庫県）、川崎医療福祉大学（岡山県）、岡山県立大学（岡山県）、日本赤十字九州国際看護大学（福岡県）、名桜大学（沖縄県）、防衛医科大学校（埼玉県）、北里大学（神奈川県）、愛知医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1197
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multi-institutional cross-sectional observational study to investigate the impact of COVID-19 pandemic on the mental health of nursing students.
Management information
Registered date
| 2021 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050657
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
