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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046651
Receipt No. R000053206
Scientific Title Comparative study
Date of disclosure of the study information 2022/01/16
Last modified on 2022/01/14

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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
Email 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
Email omura@mei.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email 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
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
2021 Year 12 Month 20 Day
Date of IRB
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
2022 Year 01 Month 14 Day


Link to view the page
URL(English) 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


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