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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004430 |
Receipt No. | 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 |
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) |
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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) |
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Scientific Title:Acronym | Cluster RCT of participatory intervention on psychosocial work environment among nurses | |
Region |
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Condition | ||
Condition | depressive symptoms | |
Classification by specialty |
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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 |
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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 |
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Interventions/Control_2 | Control group;
Routine practice except for questionnaire survey before and after intervention. |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1. Non-Responders to questionnaire survey
2. Study participants without consent 3. Nurses belonging to units involving indirect patients care |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
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Sponsor | |
Institute | Department of Preventive Medicine and Public Health, Tokyo Medical University |
Institute | |
Department |
Funding Source | |
Organization | Japan Society for the Promotion of Science |
Organization | |
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Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005297 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |