UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046651 |
|---|---|
| Receipt number | R000053206 |
| Scientific Title | Comparative study |
| Date of disclosure of the study information | 2022/01/16 |
| Last modified on | 2024/01/18 14:42:11 |
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Basic information
Public title
Relationship between the use of assistive device for nursing care and nursing care quality
Acronym
Relevance of the assistive devices for nursing care to nursing care quality
Scientific Title
Comparative study
Scientific Title:Acronym
Comparative study
Region
| Japan |
Condition
Condition
Patient handling
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the nursing care quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of comfort
Key secondary outcomes
Working time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
with/ without assistive device for nursing care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(Caregiver)
Nursing students acquiring basic nursing skills
Female
A person who have given written consent to participate in the study
(Simulated patient)
A healthy person who is interested in nursing and care, and who can understand the research and play the role of a patient
Female
A person who have given written consent to participate in the study
Key exclusion criteria
(Caregiver)
A person who is currently experiencing back pain that is interfering with his/her life
A person who has health problems and is unable to endure the study.
A person who is considered unsuitable by the project leader or subproject leader.
(Simulated patient)
A person whose weight is 62 kg or more
A person who is considered unsuitable by the project leader or subproject leader.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
Osaka University
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6879-2526
omura@mei.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
Osaka University
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6879-2526
Homepage URL
omura@mei.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS)
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
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
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
大阪大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 16 | 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
20
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
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
