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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032337
Receipt No. R000036786
Scientific Title The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Date of disclosure of the study information 2018/04/29
Last modified on 2018/04/20

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Basic information
Public title The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Acronym The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Scientific Title The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Scientific Title:Acronym The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Region
Japan

Condition
Condition Mass bleeding
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of simulation education on nurse's correspondence during mass bleeding in the operating room.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perform OSCE simulation for both groups and evaluate.
For evaluation, comprehension level is evaluated by behavioral evaluation by checklist and comparison of knowledge tests before and after.
Key secondary outcomes We will conduct a questionnaire and comprehension degree survey two weeks after the simulation and confirm the validity of the implementation time by seeing the change in understanding level over time.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Intervention period is half day in both groups

Interventions/Control_2 The number of interventions was 5 in both groups
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
22 years-old <=
Age-upper limit
39 years-old >
Gender Male and Female
Key inclusion criteria It is targeted to those who were adopted in our hospital operating room in FY 2017 and who agreed among nurses who passed one year after entering the hospital
Key exclusion criteria It does not include experienced nurse at the time of entering our hospital
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ritsuko Murai
Organization Nagoya University Hospital
Division name Nursing department
Zip code
Address 65 Tsurumai-cho, Showa-ku,Nagoya city
TEL 052-741-2111
Email ritsu819@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mika Kitano
Organization Nagoya University Hospital
Division name Nursing department
Zip code
Address 65 Tsurumai-cho, Showa-ku,Nagoya city
TEL 052-741-2111
Homepage URL
Email sarupo-piyopiyo@umin.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya 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
Address
Tel
Email

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 04 Month 29 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
2018 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 20 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036786

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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