UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048706 |
|---|---|
| Receipt number | R000055497 |
| Scientific Title | An e-learning program for continuing midwifery education on handling abuse cases: development and evaluation |
| Date of disclosure of the study information | 2022/08/20 |
| Last modified on | 2022/08/20 11:40:30 |
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Basic information
Public title
An e-learning program for continuing midwifery education on handling abuse cases: development and evaluation
Acronym
An e-learning program for continuing midwifery education on handling abuse cases: development and evaluation
Scientific Title
An e-learning program for continuing midwifery education on handling abuse cases: development and evaluation
Scientific Title:Acronym
An e-learning program for continuing midwifery education on handling abuse cases: development and evaluation
Region
| Japan |
Condition
Condition
none (healthy adult)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to develop an e-learning program to help obstetric nurses acquire the knowledge necessary to provide support for cases with high risks of abuse and to evaluate the program's usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of knowledge
Key secondary outcomes
Sense of efficacy
Satisfaction
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
Attending an e-learning course of approximately 90 minutes.
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
Female
Key inclusion criteria
Nurses with experience working in hospitals, clinics, or midwifery centers handling deliveries in the Kanto rejion.
Key exclusion criteria
Those who have already retired and do not plan to be reemployed in a hospital, clinic, or midwifery center that handles deliveries in the future.
Those who are involved in community health as a public health nurse.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Baba |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code
1568506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan.
TEL
+81-3-6834-2293
baba-kr@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Baba |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code
1568506
Address
Kamikitazawa 2-1-6, Setagaya-ku, Tokyo, Japan.
TEL
+81-3-6834-2293
Homepage URL
baba-kr@igakuken.or.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of the Mitsubishi Foundation for Social Welfare Services in 2014
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Lukes International University Research Ethics Committee
Address
Akashi-cho 10-1, Chuo-ku, Tokyo, Japan
Tel
+81-3-3543-6391
kenkyujimu@luke.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
| 2022 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
71
Results
A paired t-test showed that the posttest scores of knowledge and efficacy were significantly higher (t=14.4, p<.001, t=11.0, p<.001). McNemar's test was conducted on the percentage of correct answers for each item in the pretest and posttest. Eight items were found to have statistically significant differences (p<.001).
Results date posted
| 2022 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 36 years, and the average number of years working in obstetrics was 9.6 years.
Participant flow
Posters inviting participation in the study were displayed in the obstetric wards of medical facilities near Tokyo. The posters included a QR code to provide details of the study, which participants accessed. After understanding the purpose and significance of the study, those who consented were asked to complete a questionnaire seeking background information and a pretest. After completing the pretest, participants were provided access to the e-learning course, and those who completed the entire e-learning process were asked to complete the posttest and satisfaction questionnaire.
Adverse events
None
Outcome measures
Degree of knowledge
Sense of efficacy
Satisfaction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 07 | 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
| 2022 | Year | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055497
