Clinical trial NCT06303232: Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement
Official title: Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Complication
Keywords: Breast engorgement
manual lymphatic drainage
therapeutic ultrasound
pain
self-efficacy
post - partum women.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.


Eligibility criteria: Inclusion Criteria:

* Both primiparous or multiparous breastfeeding women
* BMI: ≤30-≥25 (14)
* Immediate puerperium with normal or C - section non-premature childbirth (19)
* Postnatal lactating mother with symptoms of breast engorgement

Exclusion Criteria:

* any breast infection, abscess, mastitis, breast cancer
* torn/bleeding or crack nipples
* any skin condition like dermatitis, psoriasis etc
* non-lactating mothers
* having heart pacemaker

Primary outcomes:
measure: Visual Analogue Scale - VAS
timeFrame: 7th day
measure: Six Point Engorgement Scale - SPE
timeFrame: 7th day
measure: Breastfeeding Self-Efficacy Scale - BSES
timeFrame: 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Innovative Health Concepts Clinic
Study officials:
affiliation: Riphah International University
name: hina gul gul, phd*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyons KE, Ryan CA, Dempsey EM, Ross RP, Stanton C. Breast Milk, a Source of Beneficial Microbes and Associated Benefits for Infant Health. Nutrients. 2020 Apr 9;12(4):1039. doi: 10.3390/nu12041039.
citation: Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.
citation: Napisah P, Widiasih R, Maryati I, Hermayanti Y, Natasya W. The effectiveness of cabbage leaf compress and the education of lactation management in reducing breast engorgement in postpartum. Open Access Macedonian Journal of Medical Sciences. 2021;9(T6):106-10.
citation: Indrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023
citation: Aprilina HD, Krislinggardini K, Isnaini N, Suratmi S. The effect of cabbage leaves compress on breast engorgement in postpartum mother. Open Access Macedonian Journal of Medical Sciences. 2021;9(T4):124-8
citation: Zutshi K, Aman I, Sachdeva T, Khatoon R. Physiotherapy Approach to Breast Engorgement: A Systematic Review. International Journal of Advanced Research in Gynaecology and Obstetrics. 2023;1(1):34-8.
citation: Varghese B, Patwa A. Effectiveness of hospital based teaching programme on knowledge regarding home management for breast engorgement among postnatal mothers. Int J Res Rev. 2020;7:486-93.