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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

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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)
Email

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
Email

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
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
Email

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
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


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