UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031752 |
|---|---|
| Receipt number | R000036114 |
| Scientific Title | Investigation of patient turning and repositioning for the development of turning device designed to reduce loads of caregivers. |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2019/09/19 10:55:37 |
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Basic information
Public title
Investigation of patient turning and repositioning for the development of turning device designed to reduce loads of caregivers.
Acronym
Investigation of patient turning and repositioning
Scientific Title
Investigation of patient turning and repositioning for the development of turning device designed to reduce loads of caregivers.
Scientific Title:Acronym
Investigation of patient turning and repositioning
Region
| Japan |
Condition
Condition
patient turning and repositioning
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate of the efficiency and features of patient turning and repositioning
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time for patient turning and repositioning
Key secondary outcomes
subjective fatigue
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the method of patient turning by oneself
Interventions/Control_2
the method of patient turning by pairs
Interventions/Control_3
the method of patient turning with assistive device by oneself
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
| Not applicable |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
having an experience as a nurse for a year or more
having an experience of patient turning
Key exclusion criteria
having low back pain and its previous history
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Inoue |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2521
t-inoue@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
Osaka university
Division name
Graduate school of medicine
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2526
Homepage URL
y-omura@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-2 Yamadaoka Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2018 | Year | 03 | 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
30
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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036114
