Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women

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

Study Overview

• Status: Completed
• Conditions: Postpartum Complication
• Intervention / Treatment: Other: MANUAL LYMPHATIC DRAINAGE; Other: THERAPEUTIC ULTRASOUND

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan, 05499
    • Innovative Health Concepts Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MANUAL LYMPHATIC DRAINAGE	Other: MANUAL LYMPHATIC DRAINAGE; MLD was performed after the moist heating of 10 minutes in supine position with both knees bent. It will start from the abdominal lymph drainage followed by the central lymph drainage. Then, by stimulating the bilateral axillary lymph nodes, the flow of the fluid was directed to the axillary lymph node. Each session lasted for approximately 45 minutes, for 7 days
Active Comparator: THERAPEUTIC ULTRASOUND	Other: THERAPEUTIC ULTRASOUND; The participants of group B will receive a treatment of manual lymphatic drainage and ultrasound after the moist heat of 10 minutes. After MLD of 45 minutes, ultrasound will be performed in small circular pattern from periphery to the center towards the areola with following parameters: Mode: pulsed, Frequency: 1MHz, Intensity: 1W/cm2, Time: 8 minutes. Treatment was given for 7 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale - VAS	VAS is an effective rule is measuring the pain score. It ranges from 0 -10 cm line scale with the following description; 0 cm = no pain 1 - 3 cm = mild pain 4 - 7 cm = moderate pain 8 - 10 cm = severe pain (20). When assessing the validity of VAS, a good-to-excellent correlation was found (r = 0.941), this scale had excellent test-retest reliability. The intra - class correlation coefficients of the VAS was 0.97	7th day
Six Point Engorgement Scale - SPE	Six point engorgement scale was the scale for the determination of the breast engorgement. The reliability of tool engorgement was 0.948 (22). The score of this scale ranges from 1 - 6. Every score has a following description; = no changes in breast / soft breast; = slight changes in breast; = firm but no breast tenderness; = firm with starting breast tenderness; = tender and firm; = very tender and very firm	7th day
Breastfeeding Self-Efficacy Scale - BSES	It includes the 14 items that measure the confidence of the breastfeeding. 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). In sum, BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy	7th day

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: hina gul gul, phd*, Riphah International University

Publications and helpful links

General Publications

• 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.
• Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.
• 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.
• Indrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023
• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pain; manual lymphatic drainage; self-efficacy; therapeutic ultrasound; Breast engorgement; post - partum women.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hyperemia
• Other Study ID Numbers: REC/RCR&AHS/23/0578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No