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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036165
Receipt No. R000041204
Scientific Title Basic studies for inventing psychological stress reduction tools for personal and daily use among nursing students.
Date of disclosure of the study information 2019/03/12
Last modified on 2019/03/12

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Basic information
Public title Basic studies for inventing psychological stress reduction tools for personal and daily use among nursing students.
Acronym Basic studies for inventing psychological stress reduction tools for personal and daily use among nursing students.
Scientific Title Basic studies for inventing psychological stress reduction tools for personal and daily use among nursing students.
Scientific Title:Acronym Basic studies for inventing psychological stress reduction tools for personal and daily use among nursing students.
Region
Japan

Condition
Condition Stress-related diseases
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this studies is to invent psychological stress reduction tools for personal and daily use among nursing students.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Public Health Research Foundation Stress Check Form (PHRFSCL-SF)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Coping list group. Each member of the group records his/her stress coping.
Interventions/Control_2 Solution list group. Each member of the group records his/her good experiences.
Interventions/Control_3 Control group. Each member of the group records his/her recollections.
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 Nursing Students
Key exclusion criteria 1.Students who are receiving psychiatry or psychosomatic care.
2. Students with a low score on the stress check scale (PHRFSCL-SF).
3. Students who are attending lectures of the principal investigator.
4. Students whose score of the stress check scale (PHRFSCL-SF) shows obvious worsening.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Fuminori
Middle name
Last name MISAWA
Organization Fukushima Medical University
Division name Integrated Center for Humanities and Sciences
Zip code 960-1295
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1838
Email f-misawa@fmu.ac.jp

Public contact
Name of contact person
1st name Fuminori
Middle name
Last name MISAWA
Organization Fukushima Medical University
Division name Integrated Center for Humanities and Sciences
Zip code 960-1295
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1838
Homepage URL
Email f-misawa@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukushima Medical University Ethical Committee
Address 1 Hikarigaoka, Fukushima, Japan
Tel 024-547-1838
Email f-misawa@fmu.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 03 Month 12 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 15 Day
Date of IRB
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 10 Month 04 Day
Last follow-up date
2021 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 03 Month 12 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041204

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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