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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041804
Receipt No. R000047724
Scientific Title A controlled intervention study of a new shift work schedule for enhancing recovery from fatigue among nurses
Date of disclosure of the study information 2020/11/01
Last modified on 2020/09/15

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Basic information
Public title A controlled intervention study of a new shift work schedule for enhancing recovery from fatigue among nurses
Acronym A controlled intervention study of a new shift work schedule for enhancing recovery from fatigue among nurses
Scientific Title A controlled intervention study of a new shift work schedule for enhancing recovery from fatigue among nurses
Scientific Title:Acronym A controlled intervention study of a new shift work schedule for enhancing recovery from fatigue among nurses
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The 2-month intervention study with cross-over design aims to examine the effects of a new shift work schedule with less quick returns and more nighttime sleep on fatigue, sleep, and near miss among nurse.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Fatigue, sleep, and near miss
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 In the intervention condition, the participants will be required to work on a new shift work schedule during 2 months.
Interventions/Control_2 In the condition, the participants will be required to work on a conventional shift work schedule during 2 months.
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
50 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria is as follows;

1)age; 20 to 50 years old
2)career; 3 years ore more
3)individual without current medication treatment
4)current shift worker
Key exclusion criteria Non-shift worker
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohide
Middle name
Last name Kubo
Organization National Institute of Occupational Safety and Health, Japan
Division name Occupational Stress and Health Management Research Group
Zip code 214-8585
Address Nagao 6-21-1, Tama-Ku, Kawasaki 214-8585 Japan
TEL 044-865-6111
Email kubo@h.jniosh.johas.go.jp

Public contact
Name of contact person
1st name Tomohide
Middle name
Last name Kubo
Organization National Institute of Occupational Safety and Health, Japan
Division name Occupational Stress and Health Management Research Group
Zip code 214-8585
Address Nagao 6-21-1, Tama-Ku, Kawasaki 214-8585 Japan
TEL 044-865-6111
Homepage URL
Email kubo@h.jniosh.johas.go.jp

Sponsor
Institute National Institute of Occupational Safety and Health, Japan
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare, Japan
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 Institutional Review Board of National Institute of Occupational Safety and Health, Japan
Address Nagao 6-21-1, Tama-Ku, Kawasaki 214-8585 Japan
Tel 044-865-6111
Email kubo@h.jniosh.johas.go.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
2020 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
2020 Year 08 Month 31 Day
Anticipated trial start date
2020 Year 10 Month 16 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 15 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047724

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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