UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060455 |
|---|---|
| Receipt number | R000069172 |
| Scientific Title | Musculoskeletal-based Breast Engorgement Study |
| Date of disclosure of the study information | 2026/01/24 |
| Last modified on | 2026/01/24 00:43:27 |
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Basic information
Public title
Evaluation of the effectiveness of a musculoskeletal-based self-care program for preventing breast engorgement
Acronym
Breast Engorgement Self-care Study
Scientific Title
Musculoskeletal-based Breast Engorgement Study
Scientific Title:Acronym
Evaluation of the effectiveness of a musculoskeletal-based self-care program for preventing breast engorgement: a quasi-experimental study
Region
| Japan |
Condition
Condition
Breast engorgement
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a musculoskeletal-based self-care program for preventing breast engorgement in the early postpartum period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of breast engorgement from postpartum day 1 to day 5 assessed on a 5-point scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
On postpartum day 1, a midwife provides individual instruction using a leaflet on neutral positioning, draw-in breathing, and self-massage of the pectoralis major, trapezius, sternocleidomastoid, and latissimus dorsi muscles. After instruction, participants perform the same self-care for at least 5 minutes before each breastfeeding session until postpartum day 5 (discharge).
Interventions/Control_2
Participants receive standard breast care provided at the participating facility.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Postpartum women who delivered vaginally and are following a standard postpartum care plan on postpartum day 1
Key exclusion criteria
Postpartum women with obstetric complications
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Misato |
Organization
Faculty of Nursing, Kyoritsu Women's University
Division name
Faculty of Nursing
Zip code
101-8437
Address
2-2-1 Hitotsubashi, Chiyoda-ku, Tokyo, Japan
TEL
03-3237-5667
kmisato@kyoritsu-wu.ac.jp
Public contact
Name of contact person
| 1st name | Orie |
| Middle name | |
| Last name | Itayama |
Organization
Meguro Mitama Midwifery Clinic
Division name
Midwifery Department
Zip code
153-0064
Address
2-21-24-201 Shimomeguro, Meguro-ku, Tokyo 153-0064, Japan
TEL
090-6196-0731
Homepage URL
o.itayama@mat-mw.net
Sponsor or person
Institute
Meguro Mitama Midwifery Clinic
Institute
Department
Personal name
Funding Source
Organization
Meguro Mitama Midwifery Clinic
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
Research Ethics Review Committee, Kyoritsu Womens University and Kyoritsu Womens Junior College
Address
3-27 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051, Japan
Tel
03-3237-5667
kimisato@kyoritsu-wu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KWU-IRBA#25023
Org. issuing International ID_1
Research Ethics Review Committee, Kyoritsu Women's University and Kyoritsu Women's Junior College
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 24 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069172
