UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042789 |
|---|---|
| Receipt number | R000048828 |
| Scientific Title | Development and Verification of Online Mindfulness program for pregnant women |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2023/03/23 15:08:26 |
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Basic information
Public title
Online Mindfulness program for pregnant women
Acronym
Online Mindfulness program for pregnant women
Scientific Title
Development and Verification of Online Mindfulness program for pregnant women
Scientific Title:Acronym
Development and Verification of Online Mindfulness program for pregnant women
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the MBCP-4-NHS developed by the University of Oxford, a Japanese version of the 4-week online program will be developed, and the effectiveness of the program will be verified by conducting a pre/post comparison of one group.
The effectiveness of the program will be verified by conducting a pre/post comparison of one group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perinatal depression(EPDS: Edinburgh Postnatal Depression Scale)
Timing; Pre and Post program, 4-6weeks after childbirth
Key secondary outcomes
Fear of childbirth(W-DEQ: Wijma Delivery Expectancy/Experience Questionnaire)
Perceived Stress(PSS: Perceived Stress Scale)
Generalized Anxiety(GAD-7: Generalized Anxiety Disorder-7)
Mindfulness (FFMQ: Five Facet Mindfulness. Questionnaire)
Self-esteem(Rosenberg self-esteem scale)
Well being(SHS: Subjective Happiness Scale)
Sense of coherence(University of Tokyo Health Sociology version of the SOC3 scale SOC3-UTHS)
Timing Pre and Post program, 4-6weeks after childbirth
Pain during childbirth(Numerical Rating Scale: NRS)
Timing:4-6weeks after childbirth
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participate in four online programs to learn about pregnancy, childbirth, childcare, and mindfulness. (Once a week for 2 hours)
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
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
130
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Midwifery and Women's health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo-to 113-0033 Japan
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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Midwifery and Women's health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo-to 113-0033 Japan
TEL
03-5841-3396
Homepage URL
mindfulbirthing.utokyo@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Univers 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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo-to 113-0033 Japan
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 22 | 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
38
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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048828
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| Registered date | File name |
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