UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051256 |
|---|---|
| Receipt number | R000058451 |
| Scientific Title | Effectiveness of an online Japanese version of mindfulness-based childbirth and parenting program |
| Date of disclosure of the study information | 2023/06/04 |
| Last modified on | 2023/07/25 10:55:37 |
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Basic information
Public title
Online Mindfulness program for pregnant women
Acronym
Online Mindfulness program for pregnant women
Scientific Title
Effectiveness of an online Japanese version of mindfulness-based childbirth and parenting program
Scientific Title:Acronym
Effectiveness of an online Japanese version of mindfulness-based childbirth and parenting program
Region
| Japan |
Condition
Condition
No disease
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a Japanese version of the 4-week online program developed based on the MBCP-4-NHS developed by the University of Oxford, we will verify the effectiveness of the program by conducting a randomized control trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Fear of childbirth(W-DEQ: Wijma Delivery Expectancy/Experience Questionnaire)
Key secondary outcomes
Prenatal Depression (EPDS: Edinburgh Postnatal Depression Scale)
Perceived Stress(PSS:Perceived Stress Scale)
Mindfulness (FFMQ: Five Facet Mindfulness Questionnaire)
Sense of coherence(Sense of coherence scale 13 SOC13)
Bonding Disorder(MIBQ The Mother-Infant Bonding Questionnaire)
Subjective Birth experience (SIL Salmon's Item List)
Catastrophizing mind for pain (PCS pain catastrophizing scale)
Pain during childbirth(Numerical Rating Scale NRS)
Medical intervention
Breast feeding
Family planning
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During pregnancy, participating in four online programs to learn about pregnancy, childbirth, childcare, and mindfulness. (4times / Once a week for 2 hours)
Interventions/Control_2
After childbirth, participating in four online programs to learn about pregnancy, childbirth, childcare, and mindfulness. (4times / Once a week for 2 hours)
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
Pregnant women over 20 years old
Women who can answer the self-administered questionnaire in Japanese and participate in the program.
Pregnancy week:16 to 34 weeks
Living in an environment with internet access
Key exclusion criteria
Those who have been diagnosed with or are currently undergoing treatment for a mental illness.
Those who are currently hospitalized.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
The University of Tokyo
Division name
Department of Midwifery and Women's health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3396
mharuna@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Tanke |
Organization
The University of Tokyo
Division name
Department of Midwifery and Women's health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3396
Homepage URL
http://mindfulbirthing2023.my.canva.site
mindfulbirthing.utokyo@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学大学院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058451
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
