Clinical trial NCT06168630: Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.
Official title: Effects of Manual Lymph Drainage on Breast Engorgement, Pain and Self Efficacy in Postpartum Period.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum
Keywords: Engorgement
Manual lymph drainage
Postpartum period
Pain
Self efficacy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 36
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling technique will be used and 35 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive manual lymph drainage and group B will receive massage whereas cold pack will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are NPRS, 6 point self rated engorgement scale and breast feeding self efficacy questionnaire. The data will be assessed after 5 days of treatment using 2 tailed t test. After data collection data will be analyzed by using SPSS version 25.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.

Women with breast cancer. Women with breast abcess. Women taking other medications.

Primary outcomes:
measure: Numerical pain rating scale
timeFrame: 5th day
measure: Six point self rated engorgement scale
timeFrame: 5th day
measure: Breast feeding self efficacy questionnaire
timeFrame: 5th day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International university, Lahore
state: Punjab
Study officials:
References:
citation: 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.
citation: Song 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.
citation: Manna 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.