UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030326 |
|---|---|
| Receipt number | 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 13:38:02 |
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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
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
morimich@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University, Graduate School of Biomedical & Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034633
| 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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