UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019762 |
|---|---|
| Receipt number | R000022821 |
| Scientific Title | The single group study on how to take the rest using a phase mask for night shift workers |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2015/12/10 13:16:50 |
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Basic information
Public title
The single group study on how to take the rest using a phase mask for night shift workers
Acronym
The single group study on how to take the rest using a phase mask for night shift workers
Scientific Title
The single group study on how to take the rest using a phase mask for night shift workers
Scientific Title:Acronym
The single group study on how to take the rest using a phase mask for night shift workers
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One of the effective methods in the rest nap during the night shift, and by using a phase mask to reveal that is effective in reduce fatigue take high quality nap.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Falling asleep feeling questionnaire, OSA sleep feeling questionnaire MA version
Key secondary outcomes
BIS monitor
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The subjects get to participate for a total of two times during the night shift.The first time nap as usual, the second time to take a nap by using the eye mask.The plan to make that twice during the one month as the period.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurse of the relevant ward
Night shift (at 15:30 for the next day 9:00) nurses who are engaged in work
Age more than 20 years of age
Gender unquestioned
After receiving a sufficient explanation Upon participation in this study, on the thorough understanding, those who sentence consent voluntary participant himself was obtained
Key exclusion criteria
Who there is an abnormality in the range that touches the eye mask, such as scratch swelling, eczema around the certain person or eyes and eye diseases and inflammation in the eye
Any person who is abnormalities such as scratches and swelling, eczema in part to affix the BIS of electrode
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sawa Tanaka |
Organization
Yamaguchi University Hospital
Division name
Nursing department Spirit neurology ward
Zip code
Address
Ube City, Yamaguchi Prefecture Minamikogushi 1-1-1
TEL
0836-22-2111
sawa.t@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawa Tanaka |
Organization
Yamaguchi University Hospital
Division name
Nursing department Spirit neurology ward
Zip code
Address
Ube City, Yamaguchi Prefecture Minamikogushi 1-1-1
TEL
0836-22-2111
Homepage URL
sawa.t@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital Nursing department Spirit neurology ward
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Hospital Nursing department
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2015 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
