UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect Of Introducing Original Oral Care Protocol For Acute Phase Stroke
Title of the study (Brief title)	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	kayowada
Organization	Fukuoka University chikishi Hospital nursing department
Division name	4 th floor stroke care unit
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	kayowada
Organization	Fukuoka University Chikushi Hospital
Division name	4 th floor stroke care unit
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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