UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056230 |
|---|---|
| Receipt number | R000064246 |
| Scientific Title | Improvement of nurse's sleep quality by minimizing frequently rotating day and night shifts: a single-arm pre-post study |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2024/11/21 21:23:49 |
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Basic information
Public title
Comparison of sleep quality associated with different work schedules in nurses
Acronym
Comparison of sleep quality associated with different work schedules in nurses
Scientific Title
Improvement of nurse's sleep quality by minimizing frequently rotating day and night shifts: a single-arm pre-post study
Scientific Title:Acronym
Improvement of nurse's sleep quality by minimizing frequently rotating day and night shifts: a single-arm pre-post study
Region
| Japan |
Condition
Condition
Sleep disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an improvement of nurse's sleep quality by minimizing frequently rotating day and night shifts.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep efficiency
Key secondary outcomes
Total Sleep Time
Sleep latency
Wake time after sleep onset
Pittsburgh sleep quality index
Epworth Sleepiness Scale
Fatigue level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Work schedule with few rotating day and night shift
Interventions/Control_2
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
Nurses working at a psychiatric ward in Fujita Health University Hospital
Key exclusion criteria
1. Nursing manager
2. Day or Night shift only
3. Part time worker
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mano |
Organization
Fujita Health University Hospital
Division name
Department of Nursing
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562932000
hp1.nurse@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masushi |
| Middle name | |
| Last name | Kohta |
Organization
Fujita Health University
Division name
Research Center for Implementation Nursing Science Initiative
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
TEL
0562932000
Homepage URL
masushi.kota@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Fujita health university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-machi, Toyoake, Aichi
Tel
0562932000
f-irb@fujita-hu.ac.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
藤田医科大学病院（愛知県）
Fujita Health University Hospital (Aichi prefecture)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064246
