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 | 2025/03/19 21:55:04 |
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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
https://www.sciencedirect.com/science/article/pii/S0266613825000981
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0266613825000981
Number of participants that the trial has enrolled
38
Results
Changes in the means of each psychological scale before and after the intervention were examined using a corresponding t-test.
Mean scores on the PSS-10 and W-DEQ-A decreased significantly after intervention; mean scores on the FFMQ, RSES, and SHS increased significantly; the FFMQ subscales "observe" and "do not judge" increased significantly; mean scores on the EPDS, GAD-7, and SOC3-UTHS did not change significantly; and mean scores on the SOC3-UTHS increased significantly.
Results date posted
| 2024 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 14 | Day |
Baseline Characteristics
The mean age was 33 years, the mean number of weeks of pregnancy was 26 weeks, and 67% of the women were first-time mothers.Seventy-three percent had experience with meditation, but most had experience with yoga, and none had experience with mindfulness programs such as the one in this study.There were 9 women who had experience with psychiatric counseling, all of whom were cured.Both household income and education were higher in this group than in the general Japanese population, with higher education and income.
Participant flow
In Study 1, 8 people participated in the intervention through the kinship method, and responses were obtained from 8 people for both before and after comparisons.
In Study 2, 42 people inquired about participating in the study by means of flyers from the cooperating institutions, of which 38 participated in the study program.Of these, 38 participated in the study program. 37 were included in the analysis, except for one who gave birth to a child before answering the post-program questionnaire.
Adverse events
none
Outcome measures
Perceived stress,Fear of childbirth,Prenatal depression,Generalised anxiety,Mindfulness,Self-esteem,Subjective happiness,Sense of Coherence
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
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048828
