UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048799 |
|---|---|
| Receipt number | R000055600 |
| Scientific Title | Endoscopic procedures consideration of ergonomic measures for physical burden of assistants. |
| Date of disclosure of the study information | 2022/08/31 |
| Last modified on | 2023/09/01 12:45:06 |
* 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
Endoscopic procedures consideration of ergonomic measures for physical burden of assistants.
Acronym
Endoscopic procedures consideration of ergonomic measures for physical burden of assistants.
Scientific Title
Endoscopic procedures consideration of ergonomic measures for physical burden of assistants.
Scientific Title:Acronym
Endoscopic procedures consideration of ergonomic measures for physical burden of assistants.
Region
| Japan |
Condition
Condition
Musculoskeletal Disorders
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on caregiver duties during endoscopic procedures, we will examine whether the introduction of stretching every 20 minutes as an ergonomic measure will reduce the physical burden on assistants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repeated measurements with crossover group comparisons (normal group/intervention group) will be performed to evaluate the effect of the stretching intervention every 20 minutes on reducing body burden based on the caregivers' NRS ratings for each body part using the Nordic Musculoskeletal Questionnaire (NMQ). A generalized linear model will be used to analyze the amount of change in physical burden from the start to the end of the assistance.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
| Other |
Interventions/Control_1
The intervention group will stretch for 1 minute every 20 minutes starting at the beginning of endoscopic procedures. Questionnaire responses will be given before, 60 minutes, and 120 minutes after the start of the procedure (or at the end of the procedure if the procedure is completed within 120 minutes).
Interventions/Control_2
The usual group will respond to questionnaires before, 60 minutes after, and 120 minutes after the start of endoscopic procedures (or at the end of the procedure if the procedure is completed within 120 minutes).
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Physicians, nurses, endoscopy assistants, and other healthcare professionals who assist in ESD and ERCP
(2) Persons who have given a full explanation of the significance and purpose of the research and obtained consent
Key exclusion criteria
(1) Those with exercise limitations
(2) Those who are currently undergoing some kind of procedure for musculoskeletal disorders
(3) Those who wear glasses regularly (contacts are acceptable)
(4) Persons who are considered ineligible by the principal investigator.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ebara |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Occupational and Environmental Health
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
052-853-8171
ebara@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mafu |
| Middle name | |
| Last name | Tsunemi |
Organization
Graduate School of Medical Sciences, Nagoya City University
Division name
Department of Occupational and Environmental Health
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL
052-853-8171
Homepage URL
yamashita_study@yamashita.or.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamashita Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Nagoya City University Faculty of Medicine Research Ethics Review Committee
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
Tel
052-853-8348
irb_jimu@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
名古屋市立大学病院（愛知県）、医療法人山下病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055600
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
