UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037733 |
|---|---|
| Receipt number | R000043038 |
| Scientific Title | Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2019/08/19 18:00:22 |
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Basic information
Public title
Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Acronym
Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Scientific Title
Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Scientific Title:Acronym
Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of action research on back pain prevention measures for ward nurses on personal and organizational changes and health related to back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recognition of low back pain / prevention in preparation factors (such as knowledge of low back pain, low back pain prevention), attitudes to low back pain prevention (interest in the prevention, sense of crisis, etc.) Burden reduction), support in the surroundings (cooperation system), acquisition of preventive technology in the realization factor (implementation of correct Vinilance), resources available for prevention (preparation of goods, rules)
Key secondary outcomes
Behavioral and organizational transformations and health improvements related to back pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Introduction of technology for moving on the bed using a plastic bag with low waist load,Health education related to back pain(Once a month for 6 months),Create an organization to prevent back pain
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All nurses working in the selected ward
Key exclusion criteria
Persons with specific low back pain or other diseases who cannot obtain the doctor's permission to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TAKUMA |
| Middle name | |
| Last name | YAMAMOTO |
Organization
Japanese Red Cross Nursing University Graduate School of Nursing Doctoral Course
Division name
Fundamental nursing
Zip code
1520004
Address
1-15-8 Takaban, Meguro-ku, Tokyo Gakugeidai Hawk Palace 101
TEL
09030487891
217D113@redcross.ac.jp
Public contact
Name of contact person
| 1st name | YUKARI |
| Middle name | |
| Last name | KAWAHARA |
Organization
Japanese Red Cross Nursing University
Division name
Fundamental nursing
Zip code
1500012
Address
4-1-3 Hiroo, Shibuya-ku, Tokyo
TEL
03-3409-0185
Homepage URL
kawahara@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross Nursing University
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Nursing University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Nursing University
Address
4-1-3 Hiroo, Shibuya-ku, Tokyo
Tel
03-3409-0185
kawahara@redcross.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
| 2019 | Year | 08 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043038
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
