UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055579 |
|---|---|
| Receipt number | R000063511 |
| Scientific Title | Effect of a Resilience Awareness Support Program for Midwives in Perinatal Medical Centers: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2025/01/07 21:36:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of a Resilience Awareness Support Program for Midwives in Perinatal Medical Centers
Acronym
Effectiveness of Resilience Support Program for Midwives
Scientific Title
Effect of a Resilience Awareness Support Program for Midwives in Perinatal Medical Centers: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Resilience Support Program for Midwives
Region
| Japan |
Condition
Condition
Mental health of midwives
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the effectiveness of the program to enable midwives to demonstrate resilience throughout their careers and continue their work in a healthier and more vibrant manner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resilience, Bidimensional Resilience Scale
Key secondary outcomes
work engagement, burnout, turnover intention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Implementation of the resilience web program (conducting all 8 sessions over a period of 4 weeks).
Interventions/Control_2
Control group: The program will be delivered to participants after the intervention group completes the program, on a voluntary basis.
While the intervention group is participating in the program, they will continue their normal daily activities.
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Midwives working at perinatal maternal and child health centers nationwide (408 centers, 411 facilities).
Key exclusion criteria
No exclusion criteria
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | UCHIMURA |
Organization
St Luke's International University
Division name
St. Lukes International University Graduate School Doctoral Program
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo. Japan
TEL
0335436391
23dn002@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | UCHIMURA |
Organization
St Luke's International University
Division name
St. Lukes International University Graduate School Doctoral Program
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo. JAPAN
TEL
0335436391
Homepage URL
https://sites.google.com/view/resilience-awareness-2024
23dn002@slcn.ac.jp
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Started as a self-funded initiative, currently applying for grants.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ochanomizu University, Mejiro University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo. JAPAN
Tel
0335436391
23dn002@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
| 2024 | Year | 10 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063511
