UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004430 |
|---|---|
| Receipt number | R000005297 |
| Scientific Title | Effects of participatory intervention for improving the psychosocial work environment on mental health among nurses: a cluster randomized controlled trial (Methodological investigation of organization-directed intervention for the stress management for nurses) |
| Date of disclosure of the study information | 2010/10/21 |
| Last modified on | 2013/06/15 13:36:32 |
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Basic information
Public title
Effects of participatory intervention for improving the psychosocial work environment on mental health among nurses: a cluster randomized controlled trial
(Methodological investigation of organization-directed intervention for the stress management for nurses)
Acronym
Cluster RCT of participatory intervention on psychosocial work environment among nurses
Scientific Title
Effects of participatory intervention for improving the psychosocial work environment on mental health among nurses: a cluster randomized controlled trial
(Methodological investigation of organization-directed intervention for the stress management for nurses)
Scientific Title:Acronym
Cluster RCT of participatory intervention on psychosocial work environment among nurses
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of participatory intervention for improving the psychosocial work environment aimed at stress prevention among nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of indicator related to mental health at 6 months or 12 months after the start of intervention.
Key secondary outcomes
Changes of indicators related to psychosocial work environment at 6 months or 12 months after the start of intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group;
Implementation of activities for improving the psychosocial work environment over 3 months.
Thirty minutes group meeting and man-to-man interview once a month.
1. Identify current situation
2. Discuss and suggest action plan
3. Follow-up progress of activities
Interventions/Control_2
Control group;
Routine practice except for questionnaire survey before and after intervention.
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
1. Nurses working in hospital
2. Respondents to questionnaire survey
3. Study participants with consent
4. Nurses belonging to units involving direct patients care
Key exclusion criteria
1. Non-Responders to questionnaire survey
2. Study participants without consent
3. Nurses belonging to units involving indirect patients care
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayako Uchiyama |
Organization
Tokyo Medical University
Division name
Department of Preventive Medicine and Public Health
Zip code
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3351-6141(ext.237)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Uchiyama |
Organization
Tokyo Medical University
Division name
Department of Preventive Medicine and Public Health
Zip code
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Preventive Medicine and Public Health, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 10 | Month | 21 | 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
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
| 2009 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2013 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005297
| 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 |
