UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of an education program to improve nurse's self-confidence for oral care.
Acronym	Efficacy of oral care education program for nurses.
Scientific Title	The efficacy of an education program to improve nurse's self-confidence for oral care.
Scientific Title:Acronym	Efficacy of oral care education program for nurses.
Region	Japan

Condition
Condition	Cerebral stroke
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of an oral care education program for improving nurse's self-confidence, knowledge, and technique of the care in acute cerebral stroke care setting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-confidence level in oral care (much confidence, a little confidence, not much confidence, no confidence)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are 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	Interventions: (a) Lecture of oral care by a dental surgeon, (b) The participants (nurses) become in pair and practice oral care, (c) The paired participants provide positive feedback to each other about the performed oral care.
Interventions/Control_2	Control_1: (a) Lecture of oral care by physician, (b) The participants (nurses) become in pair and practice oral care.
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	Nurses who are working at stroke ward in Yokohama City University Hospital
Key exclusion criteria	Nurse manager, and nurses who not consent to participate in this study
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nagano Ikumi
Organization	Yokohama City University Hospital
Division name	Nursing Department
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2800
Email	care93kenkyu@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Nagano Ikumi
Organization	Yokohama City University Hospital
Division name	Nursing Department
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2800
Homepage URL
Email	care93kenkyu@yahoo.co.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2017 Year 03 Month 01 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	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 01 Month 30 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 31 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028348