UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048333 |
|---|---|
| Receipt number | R000055089 |
| Scientific Title | A controlled intervention study of a shift work schedule with forward rotation among shift-working nurses |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/01/10 09:28:33 |
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Basic information
Public title
A controlled intervention study of a shift work schedule with forward rotation among shift-working nurses
Acronym
A controlled intervention study of a shift work schedule with forward rotation among shift-working nurses
Scientific Title
A controlled intervention study of a shift work schedule with forward rotation among shift-working nurses
Scientific Title:Acronym
A controlled intervention study of a shift work schedule with forward rotation among shift-working nurses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This intervention study with cross-over design aims to examine the effects of a shift work schedule with forward rotation on fatigue, sleep, and near miss among nurses.
Basic objectives2
Others
Basic objectives -Others
This study examines the influences of changing from backward to forward rotating 3-shift systems on fatigue and sleep among shift-working nurses.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue, sleep, quality of life, 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 not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
In the intervention condition, the participants will be required to work on a new shift work schedule with forward rotation 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: more than 3 years
3.individual without current medication treatment
4. current shift worker
Key exclusion criteria
Candidates who do not meet the selection criteria.
Target sample size
60
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
TEL
044-865-6111
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
TEL
044-865-6111
Homepage URL
kubo@h.jniosh.johas.go.jp
Sponsor or person
Institute
National Institute of Occupational Safety and Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
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
| 2022 | Year | 10 | 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
| 2022 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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 | 07 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055089
