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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032084
Receipt No. R000036573
Scientific Title The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Date of disclosure of the study information 2018/04/03
Last modified on 2018/04/05

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Basic information
Public title The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Acronym The Effect Of Oral Care Protocol For Acute Phase Stroke
Scientific Title The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Scientific Title:Acronym The Effect Of Oral Care Protocol For Acute Phase Stroke
Region
Japan

Condition
Condition Cerebral Infarction,Cerebral Hemorrhage,Subarachnoid Hemorrhage
Classification by specialty
Neurology Neurosurgery Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the effect of introducing original oral care protocol for acute phase stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oral Cleanliness(Admission Time And After 1 Week)
Key secondary outcomes Lips,Tongue,Gums,Tissues,Saliva,Natural Teeth,Denture,Dental Pain

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 We introduce an original oral care protocol which describes frequency and procedure of oral care.
We evaluate patient's oral cavity at the time of admission and one week later with OHAT.
We examine the patients with acute phase stroke who depend for "tooth brushing","denture attachment / deattachment" or "gargle" on BDR index.
Evaluators of oral cavity evaluations are the research nurses who studied the evaluation of OHAT before the oral care protocol and after the oral care protocol they are done by the SCU nurse who studied the oral care protocol and OHAT.
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 At Fukuoka University Chikushi Hospital SCU, there are 50 to 60 new hospitalized patients in about 3 months and there are also patients who are independent in BDR index "tooth brushing", "detaching of denture" and "gargle" at the time of admission, so they are in hospital Of 50 subjects who agreed to consent explanation documents from patients and their families in acute patients with partial assistance or whole-aid stroke, either "toothpaste" "detachment of denture" or "gargle" with BDR index of . In addition, the basics is the first day of hospitalization, but for emergency surgery and nighttime hospitalization the next day evaluation date shall be taken.
Key exclusion criteria At the time of hospitalization, patients with "Body Toothbrushing", "Removing Denture" and "Mouthwear" all became autonomous at the time of hospitalization, patients who were hospitalized and could not evaluate one week after hospitalization.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kayowada
Organization Fukuoka University chikishi Hospital nursing department
Division name 4 th floor stroke care unit
Zip code
Address 1-11chome zokumyoin-in chikushino-shi,fukuoka-ken
TEL 092-921-1011
Email wadak@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kayowada
Organization Fukuoka University Chikushi Hospital
Division name 4 th floor stroke care unit
Zip code
Address 1-11chome zokumyoin-in chikushino-shi,fukuoka-ken
TEL 092-921-1011
Homepage URL
Email wadak@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
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 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
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 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 04 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 03 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036573

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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