UMIN-CTR Clinical Trial

Basic information
Public title	Association between the personality trait and stress coping of nursing students
Acronym	Association between the personality trait and stress coping of nursing students
Scientific Title	Association between the personality trait and stress coping of nursing students
Scientific Title:Acronym	Association between the personality trait and stress coping of nursing students
Region	Japan

Condition
Condition	none
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the association between personality trait of nursing students and stress, or stress coping
Basic objectives2	Others
Basic objectives -Others	Association
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The personal difference of stress reaction (blood pressure, pulse, SRS:Stress Pespnse Scale) by two kinds of stress experiences
Key secondary outcomes	The personal difference of stress reaction (blood pressure, pulse, SRS:Stress Pespnse Scale) by two kinds of stress coping

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	education
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	nursing student
Key exclusion criteria	none
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kitoh Middle name Last name Chiharu
Organization	Suzuka University of Medical Science
Division name	Faculty of Nursing
Zip code	513-8670
Address	3500-3,Minamitamagaki,Suzuka-city,Mie,Japan
TEL	059-340-0550
Email	c-kitoh@suzuka-u.ac.jp

Public contact
Name of contact person	1st name Isobe Middle name Last name Atsuo
Organization	Suzuka University of Medical Science
Division name	Study promotion section
Zip code	513-8670
Address	3500-3,Minamitamagaki,Suzuka-city,Mie,Japan
TEL	059-340-0550
Homepage URL
Email	isobe@suzuka-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

Funding Source
Organization	Suzuka University of Medical Science
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	Suzuka University of Medical Science
Address	3500-3,Minamitamagaki,Suzuka-city,Mie,Japan
Tel	059-340-0550
Email	isobe@suzuka-u.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	2019 Year 11 Month 21 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
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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 28 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 21 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044050