UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039584
Receipt No. R000045141
Scientific Title A simple ergonomic work-rest measure reducing local muscular discomfort when wearing lead aprons in gastrointestinal fluoroscopic procedures
Date of disclosure of the study information 2020/02/24
Last modified on 2021/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A simple ergonomic work-rest measure reducing local muscular discomfort when wearing lead aprons in gastrointestinal fluoroscopic procedures
Acronym A simple ergonomic work-rest measure reducing local muscular discomfort when wearing lead aprons
Scientific Title A simple ergonomic work-rest measure reducing local muscular discomfort when wearing lead aprons in gastrointestinal fluoroscopic procedures
Scientific Title:Acronym A simple ergonomic work-rest measure reducing local muscular discomfort when wearing lead aprons
Region
Japan

Condition
Condition cervical syndrome
low back pain
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the effectiveness of simple ergonomic work-rest measures under gastrointestinal fluoroscopic procedures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measure muscle fatigue using electromyography
Key secondary outcomes 1. Stabilometry
2. Fatigue evaluated on visual analog scale
3. Demographic information and adherence

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Apron release during a short rest
Interventions/Control_2 Carry out the ergonomic time out
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Doctors who attend to gastrointestinal fluoroscopic procedures.
2. Who work all day for the procedures.
Key exclusion criteria 1. Who restricted for diet and/or exercise.
2. Who have musle disease under medical treatment.
3. Who wear glasses.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yasuki
Middle name
Last name Hori
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 4678601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku
TEL +81528538211
Email yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Yasuki
Middle name
Last name Hori
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code 4678601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL +81528538211
Homepage URL
Email yhori@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Nagoya City University Graduate School of Medical Sciences, Department of Occupational and Environmental Health
2. Nagoya City University School of Design and Architecture, Graduate School of Design and Architecture
3. The University of Occupational and Environmental Health, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization The IRB board of Nagoya City University Graduate School of Medical Sciences
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
Tel +81528587215
Email clinical_research@med.nagoya-cu.ac.jp

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
2020 Year 02 Month 24 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 No longer recruiting
Date of protocol fixation
2020 Year 02 Month 24 Day
Date of IRB
2020 Year 05 Month 18 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 24 Day
Last modified on
2021 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.