UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057854 |
|---|---|
| Receipt number | R000066032 |
| Scientific Title | A Study on Early Postpartum Mind-Body Interventions for Postnatal Women: Effects of Postpartum Yoga Focusing on Mood, Postpartum Depression, and Minor Symptoms |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/06/23 18:31:03 |
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Basic information
Public title
A Study on the Benefits of Early Postpartum Yoga for Physical and Mental Well-being
Acronym
Early Postpartum Yoga Study
Scientific Title
A Study on Early Postpartum Mind-Body Interventions for Postnatal Women: Effects of Postpartum Yoga Focusing on Mood, Postpartum Depression, and Minor Symptoms
Scientific Title:Acronym
Early Postpartum Yoga Study
Region
| Japan |
Condition
Condition
Depression, Mood Disorders, and Minor Symptoms in the Postpartum Period
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of postpartum yoga, initiated in the early postpartum period, on the mental and physical health of postpartum women, with a particular focus on mood, postpartum depression, and minor symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the longitudinal changes and intergroup differences in mood (assessed using the short form of POMS 2-A) and postpartum depressive symptoms (assessed using EPDS) between the postpartum yoga group and the usual care group.
Key secondary outcomes
Evaluate the pre- and post-changes in minor symptoms (presence/absence and VAS) and the between-group differences in the yoga group and the usual care group.
Evaluation Timepoints: Postpartum Day 2, Postpartum Day 4, Postpartum Week 2, Postpartum Month 1
Measurement Items: VAS(assessment of symptom intensity or discomfort)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
To examine the effects of yoga in the early postpartum period, yoga will be practiced under the guidance of a certified midwife with yoga instructor qualifications during hospitalization and after discharge
Interventions/Control_2
The control group will not receive the yoga intervention but will receive standard postpartum care, which includes regular monitoring and support by healthcare professionals. Participants in this group will receive the same postpartum recovery and support as those in the yoga intervention group, but without participating in the yoga sessions.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 18 years or older
Capable of communicating in Japanese and able to read and respond to the survey
First-time mothers who have completed a full-term vaginal delivery
No abnormal postpartum course, with approval for participation in this study obtained from the doctor
Scheduled to attend the research facility for postpartum check-up within one month
Able to participate in the study until the one-month postpartum check-up
Written informed consent obtained voluntarily from the participant
Key exclusion criteria
Women who had moderate or severe anemia during pregnancy (Hb < 9 mg/dL)
Women with postpartum hemorrhage of 500 mL or more
Women whose daily life is impaired due to back pain, joint pain, or pelvic pain
Women with severe pain that persists despite taking painkillers, impairing their daily life
Women undergoing treatment for mental health disorders (receiving medication)
Women whose newborn required transfer to another facility
Women who are certified yoga instructors
Women deemed unsuitable for participation by a doctor or midwife (e.g., high-risk pregnant women, such as those with social or medical risks)
Women who cannot provide informed consent to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yamamura |
Organization
Kitasato University Graduate School
Division name
Graduate School of Nursing, Women's Health Nursing Department
Zip code
2520373
Address
1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa Prefecture, Japan
TEL
0427789361
yamamura.kaori@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Katori |
Organization
Kitasato University
Division name
School of Nursing
Zip code
2520373
Address
1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa Prefecture, Japan
TEL
0427789361
Homepage URL
katori@nrs.kitaato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
The Clinical Research Ethics Review Committee of Kitasto University School of Nursing
Address
1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa Prefecture, Japan
Tel
0427789281
ttsukada@kitasato-u.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
| 2025 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066032
