UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of the self-care training on mental health of nurses who work at the hospital
Title of the study (Brief title)	The effects of the self-care training on mental health of nurses who work at the hospital
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of self-care training on mental health of nurses who work at the hospital
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A self-made questionnaire GHQ(General Health Questionnaire) BSCP(the Brief Scales for Coping Profile for Workers) POMS
Key secondary outcomes	narrative

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	Behavior,custom
Interventions/Control_1	the self-care training on mental health
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	Nurses who agree to participate the study among the participants of the training
Key exclusion criteria	Excludes nurses who have present or past history of psychological illness
Target sample size	40

Research contact person
Name of lead principal investigator	Chiyoko Inomata
Organization	Sapporo City University
Division name	School of Nursing
Address	Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido
TEL	011-726-2548
Email	c.inomata@scu.ac.jp

Public contact
Name of contact person	Chiyoko Inomata
Organization	Sapporo City University
Division name	School of Nursing
Address	Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido
TEL	011-726-2548
Homepage URL
Email	c.inomata@scu.ac.jp

Sponsor
Institute	Sapporo City University
Institute
Department

Funding Source
Organization	Sapporo City University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

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	2016 Year 04 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 21 Day
Anticipated trial start date	2016 Year 04 Month 21 Day
Last follow-up date	2016 Year 09 Month 29 Day
Date of closure to data entry	2016 Year 11 Month 04 Day
Date trial data considered complete	2016 Year 11 Month 10 Day
Date analysis concluded	2017 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://kango-sakuin.nurse.or.jp/company/pdf/1704825.pdf
Results
Other related information

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024584