UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036360 |
|---|---|
| Receipt number | R000041284 |
| Scientific Title | Human Factors and Ergonomics during Endoscopy: Endoscopists' mental and physical assessment (Sit-stand workstation) |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/05/08 21:52:46 |
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Basic information
Public title
Human Factors and Ergonomics during Endoscopy: Endoscopists' mental and physical assessment (Sit-stand workstation)
Acronym
Human Factors and Ergonomics during Endoscopy: Sit-stand workstation
Scientific Title
Human Factors and Ergonomics during Endoscopy: Endoscopists' mental and physical assessment (Sit-stand workstation)
Scientific Title:Acronym
Human Factors and Ergonomics during Endoscopy: Sit-stand workstation
Region
| Japan |
Condition
Condition
gastrointestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate endoscopists' mental and physical assessment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of endoscopy-related musculoskeletal injuries; neck, right and left shoulder, finger, wrist, legs, lower back ,and upper back using pre and post questionnaire for endoscopists.
Key secondary outcomes
Endoscopists' mental assessment associated with endoscopic examination and procedure using pre and post questionnaire for endoscopists.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Endoscopic examination and procedures, Cases with written and oral informed consent are included.
Key exclusion criteria
Cases with severe complications are excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Hattori |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
491-8531
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
m.hattori@yamashita.or.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Matsuzaki |
Organization
Medical corporation Yamashita Hospital
Division name
Gastroenterology
Zip code
491-8531
Address
1-3-5, Nakamachi, Ichinomiya
TEL
0586-45-4511
Homepage URL
imatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Medical corporation Yamashita Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical corporation Yamashita Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Yamashita Hospital
Address
1-3-5, Nakamachi, Ichinomiya
Tel
0586-45-4511
h.sakazaki@yamashita.or.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
| 2019 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopists' mental and physical assessment during sit stand workstation is evaluated for endoscopic examinations and procedures.
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041284
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
