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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303232
Enrollment
42
Registered
2024-03-12
Start date
2023-02-23
Completion date
2024-08-19
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Complication

Keywords

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

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.

Interventions

OTHERMANUAL 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

OTHERTHERAPEUTIC 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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale - VAS7th dayVAS 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
Six Point Engorgement Scale - SPE7th daySix 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
Breastfeeding Self-Efficacy Scale - BSES7th dayIt 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026