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Completed

NCT Number: NCT06303232

Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

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

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Key information

Conditions

Postpartum Complication Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Innovative Health Concepts Clinic

Lahore, 05499, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Visual Analogue Scale - VAS

    Time frame: 7th day

    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

  2. Six Point Engorgement Scale - SPE

    Time frame: 7th day

    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

  3. Breastfeeding Self-Efficacy Scale - BSES

    Time frame: 7th day

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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