UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036165 |
|---|---|
| Receipt number | 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 | 2021/04/01 10:22:02 |
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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
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
f-misawa@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
73
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
| 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
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041204
