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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031690
Receipt No. 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

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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
Email 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
Email info@kotsubaki.com

Sponsor
Institute Kotsubaki internal medical clinic
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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