Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.
1 other identifier
interventional
36
1 country
1
Brief Summary
There have been many studies on the treatment of breast engorgement, there is a lack of research comparing the effectiveness of manual lymph drainage with massage. Therefore, this study will be a randomized controlled trial that aims to compare the effects of manual lymph drainage with massage on breast engorgement, pain, and self efficacy in the postpartum period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2023
CompletedFirst Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2024
CompletedDecember 13, 2023
December 1, 2023
9 months
December 4, 2023
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Numerical pain rating scale
The Numerical pain rating scale is the most commonly used pain scale in the health care. This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10
5th day
Six point self rated engorgement scale
Six point self rated engorgemet scale is valid and reliable measures to assess breast engorgement and pain
5th day
Breast feeding self efficacy questionnaire
The divergent validity of the BSES-SF was proved via a significant negative correlation with scores of the Edinburgh Postnatal Depression Scale (r = - 0.273, P \< 0.001). BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy
5th day
Study Arms (2)
Manual Lymph Drainage
EXPERIMENTALControl group
OTHERInterventions
It consists of patients who will receive manual lymph drainage everyday for 5 days. The subject's position will be supine with their knees bent. Every session will be of 45 minutes. Manual lymph drainage will with abdominal lymph drainage, after which central lymph stimulation will be performed. Then, by stimulating the bilateral axillary lymph nodes, the flow of fluid over the right and left breasts will be directed toward the axillary lymph nodes. While the patients in the prone position, bilateral axillary lymph nodes will be stimulated, and each manual lymph drainage will be performed from the dorsum to the axillary lymph node .
The other group will receive massage for 20 minutes every day for 5 days from first day of treatment. Massage will be done using the index and middle fingers in a spiral motion towards the nipples.
Eligibility Criteria
You may qualify if:
- Women aged 25 to 35 years. Lactating mothers who presents with breast pain after birth. Women with breast heaviness. Women who rate themselves 4 on engorgement scale on six-point self-rated engorgement scale.
You may not qualify if:
- Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.
- Women with breast cancer. Women with breast abcess. Women taking other medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah International university, Lahore
Lahore, Punjab Province, Pakistan
Related Publications (3)
Monazzami M, Yousefzadeh S, Rakhshandeh H, Esmaeili H, Afiat M. The effect of hot ginger compress (Zingiber officinale) on the severity of breast engorgement in lactating women. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2019;21(12):77-84.
BACKGROUNDSong JA, Hur MH. A Systematic Review of Breast Care for Postpartum Mothers. Korean J Women Health Nurs. 2019 Sep;25(3):258-272. doi: 10.4069/kjwhn.2019.25.3.258. Epub 2019 Sep 2.
PMID: 37679918BACKGROUNDManna M, Podder L, Devi S. Effectiveness of hot fomentation versus cold compression on breast engorgement among postnatal mothers. International Journal of Nursing Research and Practice. 2016;3(1):13-8.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
December 4, 2023
First Posted
December 13, 2023
Study Start
April 5, 2023
Primary Completion
January 1, 2024
Study Completion
January 10, 2024
Last Updated
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share