UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049854 |
|---|---|
| Receipt number | R000056514 |
| Scientific Title | Exploratory study of Wellness Recovery Action Plan (WRAP) for mental health care of nurses by randomized control trial |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2023/10/13 08:45:34 |
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Basic information
Public title
Exploratory study of Wellness Recovery Action Plan (WRAP) for mental health care of nurses by randomized control trial
Acronym
Exploratory study of WRAP for nurses
Scientific Title
Exploratory study of Wellness Recovery Action Plan (WRAP) for mental health care of nurses by randomized control trial
Scientific Title:Acronym
Exploratory study of WRAP for nurses
Region
| Japan |
Condition
Condition
nurses with mental health problems
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the group in which nurses participated in the WRAP workshop showed improvement in mental health and stress after six months compared to the group in which they do not participate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WHO-5 scores after 6 months of intervention for nurses
Key secondary outcomes
K6 Japanese version
24-item Recovery Assessment Scale (RAS) Japanese version
Five-Item Subjective Agency Scale (SPA-5)
Short version of the Japanese Utrecht Work Engagement Scale (UWES)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
4 hours of WRAP workshop
Interventions/Control_2
Don't take the 4 hours WRAP workshop
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nurse qualification
Those who are engaged in nursing work at the time of consent acquisition
Nursing staff who have received sufficient explanation about participating in this research, and who have obtained the voluntary consent of the research subject after sufficient understanding.
Key exclusion criteria
Nurses who have already created a WRAP plan
Nursing staff judged by the principal researcher to be inappropriate as research subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yayama |
| Middle name | |
| Last name | So |
Organization
Kansai Medical University
Division name
Faculty of nrsing
Zip code
573-1004
Address
2-2-2 Shinmachi, Hirakata, Osaka
TEL
072-804-0047
yayamas@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yayama |
| Middle name | |
| Last name | So |
Organization
Kansai Medical University
Division name
Faculty of nrsing
Zip code
5731004
Address
2-2-2 Shinmachi, Hirakata, Osaka
TEL
072-804-0047
Homepage URL
yayamas@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
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
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
072-804-0101
rinriirb@hirakata.kmu.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 | 12 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
