UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030326
Receipt No. R000034633
Scientific Title Effectiveness of using a workbook as supplementary teaching material for improvement of understanding of stroke rehabilitation nursing
Date of disclosure of the study information 2017/12/10
Last modified on 2019/11/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effectiveness of using a workbook as supplementary teaching material for improvement of understanding of stroke rehabilitation nursing
Acronym Effectiveness of workbook-use for stroke rehabilitation nursing
Scientific Title Effectiveness of using a workbook as supplementary teaching material for improvement of understanding of stroke rehabilitation nursing
Scientific Title:Acronym Effectiveness of workbook-use for stroke rehabilitation nursing
Region
Japan

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

Objectives
Narrative objectives1 In addition to lectures and practicum, using a workbook specifically demonstrating stroke rehabilitation nursing as a supplementary teaching material, nursing students will understand the role of nursing, acquire knowledge and skills, and become easy to make patient assessment, care plan and its implementation. As a result, we consider that students' anxiety decrease, self-efficacy improve, and attitude become positive. In this research, we evaluate these effects by using a workbook as a supplementary teaching material.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Knowledge test
2. Nursing skill checklist
3. Comprehensive evaluation of clinical practicum (Subjective satisfaction, achievement levels, comprehensive understandings on nursing roles, and use of the workbook)
4. STAI (State-Trait Anxietry Inventory-Form JYZ)
These do not relate to academic grading.
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
Other
Interventions/Control_1 Creat a workbook on stroke rehabilitation nursing and lecture on nursing students about the contents and use of the workbook before clinical practicum. Nursing students use this workbook during practical training. The use of the workbook is left to the subjectivity of each student.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The third grade nursing students at Hiroshima University who attend clinical practicum on rehabilitation nursing.
Key exclusion criteria Not above
Target sample size 70

Research contact person
Name of lead principal investigator
1st name MICHIKO
Middle name
Last name MORIYAMA
Organization Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name Division of Nursing Science
Zip code 734-8553
Address Hiroshima
TEL 082-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name MICHIKO
Middle name
Last name MORIYAMA
Organization Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name Health Science Major
Zip code 734-8553
Address Hiroshima
TEL 082-257-5365
Homepage URL
Email morimich@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University, Graduate School of Biomedical & Health Sciences
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University Research Ethics Committee
Address Kasumi 1-2-3, Minami-ku
Tel 082-257-1576
Email kasumi-kenkyu@office.hiroshima-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
2017 Year 12 Month 10 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034633
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000034633
Number of participants that the trial has enrolled 64
Results
1. After the average score of the knowledge confirmation test was improved, but the state anxiety did not change.
2. 42.1% of students answered 4: I think so by using the workbook.
3. the higher the overall evaluation score, the easier it was to understand the role of the nurse and easy to use the workbook.
4. Workbook could be used in groups with high overall evaluation scores.
5. The student's impression was that the workbook was easy to understand and useful.
Results date posted
2019 Year 11 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants are third-year students of Hiroshima University School of Medicine, Department of Health and Nursing.
Participant flow
1) Registration of the Target 
Orientation for Stroke Recovery Rehabilitation Nursing Practice (hereinafter, Practice) for Students has ended.
After that, i invited the participation of the research using explanatory documents. Participation in research is conducted independently of the class, and
the purpose of the research, the flow of research, and ethical considerations, and obtained written consent. An ID number (serial number) was provided to the student who obtained consent, and all questionnaires were number ed. 
 
2) Collection of baseline data To students who have agreed, questionnaires were distributed and baseline data was collected. 
 
3) Conducting group training After collecting the questionnaire, the workbook was distributed and a group training was conducted for about 30 minutes. The training includes how to create a workbook, how to frame the workbook and how to use the workbook, and the contents of the workbook. We also watched the essence of the Yumanitude video (about 10 minutes). 
 
4) Students in the Convalegi Nursing Practice participated in the Adult Nursing Practice III (Recovery Period) held from September to December 2017 and used the workbook. 
 
5) Conduct post-training evaluations 
After the end of the practice on the last day of the training, the students filled out a questionnaire and submitted it to the researcher. Knowledge verification test only
at the end of the training, it was filled in at the training site and posted in the collection box set up by the researcher. For the other questionnaires, it was submitted to the designated box the week after the end of the training.
Adverse events
In order to prevent the disadvantages of the subject from occurring, students who do not participate in the study are recruited from among those who have not participated in the study after completing Adult Nursing Practice III. After handing the workbook to the applicant, we decided to receive the same classes as those of the research participants.
Outcome measures
Knowledge confirmation test
Technical checklist
STAI
Post-practice satisfaction and review questionnaire (overall evaluation)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 25 Day
Date of IRB
2017 Year 08 Month 25 Day
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.