Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060455) titled 'Evaluation of the effectiveness of a musculoskeletal-based self-care program for preventing breast engorgement' on Jan. 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Meguro Mitama Midwifery Clinic
Condition:
Condition - Breast engorgement
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 128
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069172
Disclaimer: Curated by HT Syndication.
