UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031690 |
|---|---|
| Receipt number | R000036193 |
| Scientific Title | Blood Pressure and Double Product Variation during Care Work (Semi-night and Daytime Shifts) and the Influence of Nighttime Napping on Early Morning Work |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2018/03/12 19:18:11 |
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Basic information
Public title
Blood Pressure and Double Product Variation during Care Work (Semi-night and Daytime Shifts) and the Influence of Nighttime Napping on Early Morning Work
Acronym
Blood Pressure and Double Product Variation during Care Work
Scientific Title
Blood Pressure and Double Product Variation during Care Work (Semi-night and Daytime Shifts) and the Influence of Nighttime Napping on Early Morning Work
Scientific Title:Acronym
Blood Pressure and Double Product Variation during Care Work
Region
| Japan |
Condition
Condition
shiftwork
Classification by specialty
| Cardiology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study sought to clarify the degree of physical burden experienced during care work by measuring and comparing the hemodynamic indices of blood pressure, heart rate, and double product among nursing care staff working on a two-shift system in a special nursing home for the aged.
Basic objectives2
Others
Basic objectives -Others
In addition, the study examined whether the physical burden of early morning care work can be reduced by nighttime napping.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
HR, Double product
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who had systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more in company health examination were defined as a hypertension group, and participants who had systolic blood pressure less than 140 mm Hg, diastolic blood pressure less than 90 mm Hg were also defined as a non-hypertension group.
Key exclusion criteria
Those using drugs that affect drowsiness, such as antidepressants, sleeping pills, antiallergic agents, etc. were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kato |
Organization
Kotsubaki internal medical clinic
Division name
Internal medicine
Zip code
Address
4275-1, Mita, Shirakicho, Asakita-ku, Hiroshima City, 739-1521, Japan
TEL
0828106700
info@kotsubaki.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Kato |
Organization
Kotsubaki internal medical clinic
Division name
Internal medicine
Zip code
Address
4275-1, Mita, Shirakicho, Asakita-ku, Hiroshima City, 739-1521, Japan
TEL
0828106700
Homepage URL
info@kotsubaki.com
Sponsor or person
Institute
Kotsubaki internal medical clinic
Institute
Department
Personal name
Funding Source
Organization
Kosubaki internal medical clinic
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 15 | 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
| 2012 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
This was a cross-sectional study. The study was conducted among 30 nursing care staff members (7 male, 23 female) in a special nursing home for the aged. The average age of the participants was 39.5 +/- 11.5 years, and in all cases 24 hour blood pressure, heart rate, and double product were measured using ambulatory blood pressure monitoring (ABPM, TM-2431, A&D Co., Ltd., Tokyo). At the end of the shift, the participants confirmed whether they had taken a nap and how much they had slept, in a questionnaire. The results were analyzed using a paired t test, an unpaired t-test, and a one-way analysis of variance.
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036193
| 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 |
