Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

NCT06303232 | Completed

• 1 other identifier: REC/RCR&AHS/23/0578
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Complication

Keywords

Breast engorgement; manual lymphatic drainage; therapeutic ultrasound; pain; self-efficacy; post - partum women.

Outcome Measures

Primary Outcomes (3)

• 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; 1. = no changes in breast / soft breast 2. = slight changes in breast 3. = firm but no breast tenderness 4. = firm with starting breast tenderness 5. = tender and firm 6. = 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

Study Arms (2)

MANUAL LYMPHATIC DRAINAGE

EXPERIMENTAL

Other: MANUAL LYMPHATIC DRAINAGE

THERAPEUTIC ULTRASOUND

ACTIVE COMPARATOR

Other: THERAPEUTIC ULTRASOUND

Interventions

MANUAL LYMPHATIC DRAINAGE OTHER

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

MANUAL LYMPHATIC DRAINAGE

THERAPEUTIC ULTRASOUND OTHER

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

THERAPEUTIC ULTRASOUND

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: POST - PARTUM WOMEN
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Innovative Health Concepts Clinic

Lahore, 05499, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 32283875 BACKGROUND

• Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.

  BACKGROUND

• 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.

  BACKGROUND

• Indrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Manual Lymphatic Drainage; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Diathermy; Hyperthermia, Induced

Study Officials

• hina gul gul, phd*

  Riphah International University

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: February 23, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 19, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)