UMIN-CTR Clinical Trial

Basic information
Public title	Real feeling of fresh nurses during COVID-19 pandemic
Acronym	Real feeling of fresh nurses during COVID-19 pandemic
Scientific Title	Real feeling of fresh nurses during COVID-19 pandemic
Scientific Title:Acronym	Real feeling of fresh nurses during COVID-19 pandemic
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to obtain suggestions for new employee education for the next fiscal year by clarifying the reality felt by new nurses who have practiced infectious diseases.
Basic objectives2	Others
Basic objectives -Others	Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	No.1 Gender No.2 Age No.3 Assignment center No.4 Satisfaction with clinical training No.5 The clinical training lived in the field No.6 What I wanted to learn more in clinical training No.7 What I felt difficult during clinical training No.8 What I found difficult after starting work as a nurse No.9 I did the actual work and felt a gap with the clinical training No.10 8 items related to human relations in the workplace No.11 14 items related to physical factors No.12 12 items related to mental factors No.13 7 items related to busy work and treatment No.14 9 items related to job satisfaction and fun No.15 6 items related to the sense of responsibility for business No.16 6 items related to Corona
Key secondary outcomes

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	21 years-old <=
Age-upper limit	49 years-old >=
Gender	Male and Female
Key inclusion criteria	Less than 1 year as a nurse
Key exclusion criteria	Over 1 year of experience as a nurse
Target sample size	110

Research contact person
Name of lead principal investigator	1st name ikumi Middle name Last name yoshitani
Organization	Saitama Medical University International Medical Center
Division name	Nursing department
Zip code	350-1298
Address	1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL	042-984-4111
Email	is5831@5931.saitama-med-ac.jp

Public contact
Name of contact person	1st name ikumi Middle name Last name yoshitani
Organization	Saitama Medical University International Medical Center
Division name	Nursing department
Zip code	350-1298
Address	1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL	042-984-4111
Homepage URL
Email	is5831@5931.saitama-med-ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical University International Medical Center
Address	1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
Tel	042-984-4111
Email	imc_irb@saitama-med-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

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	87
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 09 Month 08 Day
Date of IRB	2021 Year 09 Month 15 Day
Anticipated trial start date	2021 Year 10 Month 27 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 01 Month 16 Day
Last modified on	2022 Year 01 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052427

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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