UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040236 |
|---|---|
| Receipt number | R000045904 |
| Scientific Title | Effectiveness of an Educational Program for Practicum Instructors |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/04/28 17:50:33 |
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Basic information
Public title
Effectiveness of an Educational Program for Practicum Instructors to Promote Novice Midwives' Clinical Judgment: Cluster Randomized Controlled Trial
Acronym
Effectiveness of an Educational Program for Practicum Instructors
Scientific Title
Effectiveness of an Educational Program for Practicum Instructors
Scientific Title:Acronym
Effectiveness of an Educational Program for Practicum Instructors
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of an educational program for practicum instructors to promote the clinical judgment ability of novice midwives during delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Educational skills
Key secondary outcomes
Attitude,Knowledge,Satisfaction level,Practice status of learning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention:Taking an educational program
Interventions/Control_2
Controll:Not taking an educational program
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Midwives who are planning to educate novice midwives who are responsible for pregnant women during delivery, or midwives within 5 years after starting education
Key exclusion criteria
Not applicable
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Yamamoto |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1,akasicho,chuo-ku,Tokyo
TEL
0335436391
18dn018@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Yamamoto |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1,akasicho,chuo-ku,Tokyo
TEL
0335436391
Homepage URL
18dn018@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Japan Academy of Midwifery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1,akasicho,chuo-ku,Tokyo
Tel
0335436391
18dn018@slcn.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.nedt.2022.105658
Number of participants that the trial has enrolled
77
Results
No differences in baseline characteristics of participants and facilities were noted. There was no significant difference in educational skills scores at post-test between the intervention and control group . There was no significant difference in attitude scores at post-test between the two groups. The knowledge scores at post-test were significantly higher in the intervention group .
Results date posted
| 2023 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no differences in participants and facilities between the intervention and the control group.
Participant flow
Overall, 25 facilities met the eligibility criteria, of which 21 (77 participants) consented to participate in the study. 11 facilities (44 participants) were randomly assigned to the intervention group and 10 facilities (33 participants) to the control group. Total of 33 participants responded to the post-test, so the follow-up rate at post-test was 75% in the intervention group. At one month the intervention group had 9 facilities (31 participants). The control group retained 10 facilities (31 participants). The follow-up rate was 94% in the control group.
Adverse events
None
Outcome measures
Educational Skills, Attitude, Knowledge, Satisfaction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045904
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| Registered date | File name |
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