UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038444 |
|---|---|
| Receipt number | R000043807 |
| Scientific Title | The effects of the nap environmental system on 16-hour night shift nurses |
| Date of disclosure of the study information | 2019/10/30 |
| Last modified on | 2023/06/12 13:09:45 |
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Basic information
Public title
The effects of the nap environmental system on 16-hour night shift nurses
Acronym
The effects of the nap environmental system on 16-hour night shift nurses
Scientific Title
The effects of the nap environmental system on 16-hour night shift nurses
Scientific Title:Acronym
The effects of the nap environmental system on 16-hour night shift nurses
Region
| Japan |
Condition
Condition
Healthy nurses who work on 16-hour night shift
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of the nap environmental system on nurses' sleeps, fatigues and activities by using after 16-hour night shift
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective fatigue
Sleep parameters measured by an activity monitoring device
Subjective evaluation of sleep in using the nap environmental system
Key secondary outcomes
Rest / activity parameters measured from post using the nap environmental system until one day after night shift finished
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Take 30-minuite rest / nap with the nap environmental system after 16-hour night shift and go back home
Interventions/Control_2
Go back home without using the nap environmental system after 16-hour night shift
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
Nurses who work 16-hour night shift
Key exclusion criteria
Novice nurse
Who receive any medical treatments
Who regularly use a sleeping pill
Who are pregnant
Who has difficulty for safely using the nap environmental system, such as epilepsy or claustrophobia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
0600812
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido 060-0812, Japan
TEL
011-706-3323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
0600812
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-3323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Hokkaido University
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-3323
r-yano@med.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043807
| 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 |
