UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of an anti-fatigue mat on the reduction of lower limbs fatigue of scrub nurses
Title of the study (Brief title)	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	Yoshiko Hayashi
Organization	Yamaguchi University medical hospital
Division name	Surgery Department
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	Yoshiko Hayashi
Organization	Yamaguchi University medical hospital
Division name	Surgery Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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