UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032069 |
|---|---|
| Receipt number | 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 09:29:58 |
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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
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
komo@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
