UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062903 |
|---|---|
| Receipt number | R000072024 |
| Scientific Title | Effectiveness of an e-learning program on the prevention of child maltreatment from pregnancy: a randomized controlled trial among nurses in maternity hospitals |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 02:30:18 |
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Basic information
Public title
Effectiveness of an e-learning program on prevention of child maltreatment from pregnancy for midwives and nurses in obstetric facilities: a randomized controlled trial
Acronym
E-learning on child maltreatment prevention for nurses in maternity hospitals: a randomized controlled trial
Scientific Title
Effectiveness of an e-learning program on the prevention of child maltreatment from pregnancy: a randomized controlled trial among nurses in maternity hospitals
Scientific Title:Acronym
Effectiveness of an e-learning program on the prevention of child maltreatment from pregnancy: a randomized controlled trial among nurses in maternity hospitals
Region
| Japan |
Condition
Condition
Midwives and nurses working in maternity hospitals
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate, in a wait-list controlled randomized trial, the effectiveness of an e-learning program on the prevention of child maltreatment from pregnancy, designed to strengthen the ability of midwives and nurses in obstetric facilities to identify parents and infants of concern and to collaborate with other agencies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of the Nursing Engagement with Children Maltreatment Prevention Scale for Obstetric Ward Nurses (NES-CMP; 30 items, 5-point scale) at 3 months after the program (T3). Groups will be compared by analysis of covariance adjusted for the baseline (T0) score.
Key secondary outcomes
1. Total NES-CMP score at 1 month after the program (T2), and subscale scores at T2 and T3
2. Self-efficacy score for nursing practice with parents and infants of concern or in need of support (investigator-developed, 7 items, 6-point Likert scale) at T1, T2 and T3
3. Scores for outcome expectations (4 items), mental image of the trajectory of parents and infants after discharge (3 items), and behavioral intention (6 items) at T1, T2 and T3
4. Knowledge of child maltreatment (9 items) at T1
5. Change from baseline (T0) at each time point
6. Longitudinal change from T0 to T3 in the early-training group
7. Pre-post change in the wait-list group after receiving the program (replication of the effect)
8. Evaluation of the program (comprehensibility of each module, perceived usefulness for practice, satisfaction)
9. Exploratory analysis: mediating effects of self-efficacy, outcome expectations, mental image of the trajectory of parents and infants after discharge, and behavioral intention (T1) on nursing practice (NES-CMP at T3)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Early-training group (intervention). After randomization, participants take an on-demand e-learning program on the prevention of child maltreatment from pregnancy (120 minutes, 8 modules: basic knowledge of child maltreatment; current situation of child maltreatment and the role of obstetric facilities; characteristics and strengths of obstetric facilities; roles and support provided by public health and welfare agencies; basic principles of support and interprofessional collaboration; and three case studies) within a one-month access period. Two automated reminders are sent by the learning management system. Web-based questionnaires are administered at T0 (before the program), T1 (immediately after), T2 (1 month after) and T3 (3 months after).
Interventions/Control_2
Wait-list group (control). After randomization, participants complete the same web-based questionnaires at the same time points (T0, T1, T2 and T3) and report events during the waiting period that may affect outcomes (attendance at related training, experience with parents and infants at risk of maltreatment, and participation in case conferences). After T3, they receive the same e-learning program under the same conditions as the early-training group.
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
1. Midwives or nurses working in obstetric wards or outpatient departments of hospitals or clinics that provide delivery care
2. Engaged in direct nursing care for pregnant, parturient and postpartum women and newborns
3. Able to complete the e-learning program and respond to web-based questionnaires
4. Provided informed consent after receiving a written explanation of the study
Key exclusion criteria
1. Those who are mainly engaged in administrative duties and do not provide direct nursing care for pregnant, parturient and postpartum women and newborns
2. Those who have difficulty participating in the study or responding to web-based questionnaires
3. Those who have previously attended the same or equivalent training program on the prevention of child maltreatment from pregnancy conducted by the investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Karata |
Organization
Himeji University
Division name
School of Nursing
Zip code
671-0101
Address
2042-2 Oshio-cho, Himeji, Hyogo, Japan
TEL
079-262-6294
noriko_karata@koutoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Karata |
Organization
Himeji University
Division name
School of Nursing
Zip code
671-0101
Address
2042-2 Oshio-cho, Himeji, Hyogo, Japan
TEL
079-262-6294
Homepage URL
noriko_karata@koutoku.ac.jp
Sponsor or person
Institute
Himeji University
Institute
Department
Personal name
Noriko Karata
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Health and Nursing Science, Wakayama Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Himeji University
Address
2042-2 Oshio-cho, Himeji, Hyogo, Japan
Tel
079-247-7301
kenkyu_gakujyutu@koutoku.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
| 2026 | Year | 09 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072024
