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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032069
Receipt No. R000036515
Scientific Title Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses in the Stroke Care Unit
Date of disclosure of the study information 2018/04/03
Last modified on 2019/05/13

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Basic information
Public title Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses in the Stroke Care Unit
Acronym Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses
Scientific Title Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses in the Stroke Care Unit
Scientific Title:Acronym Efficacy of the Oral Health Care Protocol on Practical Skill of Nurses
Region
Japan

Condition
Condition Acute stage of stroke
Classification by specialty
Neurosurgery Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will clarify the changes in practical skills of SCU nurses' oral care by introducing oral care protocol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Four items and consciousness (8 items), knowledge (4 items), technology (4 items), awareness and knowledge, technology and promotion of activities before and after the use of the oral care protocol, questionnaire survey conducted, consciousness and knowledge, 11 items), promotion of activities (5 items), the change in the total score (after introduction and before introduction) is the main evaluation item. Main evaluation items are compared before and after introduction by Paired-t test.
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Perform questionnaire surveys before and after the oral care protocol introduction. The contents of the questionnaire are "5: Very applicable", "4: It is quite true", "3: Extremely applicable", "3: Extremely applicable", "3: : Approximately applicable "" 2: Not very applicable "" 1: Not applicable at all ", and a partial multiple answer format.
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 Male and Female
Key inclusion criteria All 25 SCU nurses involved in nursing patients in the acute phase of stroke
Key exclusion criteria SCU nurse manager (nurse president, chief nurse) involved in nursing patients in the acute phase of stroke
Target sample size 23

Research contact person
Name of lead principal investigator
1st name kayo
Middle name
Last name wada
Organization Fukuoka University Chikushi Hospital Nursing department
Division name 4 th floor SCU
Zip code 8188502
Address Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 - 1
TEL 0929211011
Email wadak@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name chiaki
Middle name
Last name komoda
Organization Fukuoka University Chikushi Hospital
Division name 4 th floor SCU
Zip code 8188502
Address Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 - 1
TEL 0929211011
Homepage URL
Email komo@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Fukuoka University Chikushi Hospital
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 Fukuoka University Chikushi Hospital
Address Fukuoka prefecture Chikushino city zokumyouin 1 - chome 1 -1
Tel 0929211011
Email komo@fukuoka-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 04 Month 03 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 44
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
2018 Year 01 Month 29 Day
Date of IRB
2018 Year 04 Month 13 Day
Anticipated trial start date
2018 Year 06 Month 04 Day
Last follow-up date
2019 Year 04 Month 28 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 04 Month 02 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036515

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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