UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039584 |
|---|---|
| Receipt number | 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 | 2023/08/29 08:45:50 |
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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
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
yhori@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/36069285/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36069285/
Number of participants that the trial has enrolled
25
Results
The mean occlusion rate was 5.2 and 1.6 for upper and lower limb movements, respectively. Of the 32 landmarks, 28 (87.5%) had occlusion rates of 10% or less. The mean SDs of 4.2 mm for distance and 1.2 for orientation were found. Most of the R2 values were over 0.9. In the case of right upper/lower limb measurement for orientation.
Results date posted
| 2023 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
None
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 07 | Day |
Baseline Characteristics
Completed accuracy and precision of ergonomic motion tracking system for endoscopy suite (EMTES)
Participant flow
Completed accuracy and precision of ergonomic motion tracking system for endoscopy suite (EMTES)
Adverse events
None
Outcome measures
Completed accuracy and precision of ergonomic motion tracking system for endoscopy suite (EMTES)
Plan to share IPD
None
IPD sharing Plan description
None
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
Processing
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045141
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