UMIN-CTR Clinical Trial

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
Email	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
Email	baba-kr@igakuken.or.jp

Sponsor
Institute	St. Luke's International University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055497