UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026071 |
|---|---|
| Receipt number | 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 16:35:04 |
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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
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
yoshikoh@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University medical hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029953
