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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026071
Receipt No. R000029953
Scientific Title Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Date of disclosure of the study information 2017/02/09
Last modified on 2017/02/09

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Basic information
Public title Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Acronym Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Scientific Title Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Scientific Title:Acronym Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Region
Japan

Condition
Condition none
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 IN order to reduce lower limbs fatigue without doing self-care,we used an anti-fatigue mat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes scrub nurses feeling of lower limbs gatigue were conduced using Visual Analog scale.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Scrub nurses worked without mat and a few days later,worked on mat.
Interventions/Control_2 Scrub nurses worked on mat and a few days later,worked without mat.
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 Female
Key inclusion criteria Targeted to nurses who meet all the following criteria:
1) Yamaguchi University Medical Department attached hospital surgery department nurse
2) age is over 20 years old and less than a 50-year-old.
3) women
4) who will make instruments out of over three hours of laparoscopic surgery or laparotomy surgery time
5) instruments out time is three hours or more plan to less than five hours. 6) who later received a sufficient explanation, to participate in this study, sufficient understanding on the free will of the person in document consent was obtained by
Key exclusion criteria We judged that the study person in charge was improper.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiko Hayashi
Organization Yamaguchi University medical hospital
Division name Surgery Department
Zip code
Address Yamaguchi Ube-Shi Minami-kogushi 1-1-1
TEL 0836-22-2614
Email yoshikoh@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Hayashi
Organization Yamaguchi University medical hospital
Division name Surgery Department
Zip code
Address Yamaguchi Ube-Shi Minami-kogushi 1-1-1
TEL 0836-22-2614
Homepage URL
Email yoshikoh@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University medical hospital
Institute
Department

Funding Source
Organization none
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
2017 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 29 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
2017 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029953

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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