Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

Not Applicable

Recruiting

• Conditions: Postpartum Complication
• Interventions: Other: MANUAL LYMPHATIC DRAINAGE; Other: THERAPEUTIC ULTRASOUND

• Registration Number: NCT06303232
• Lead Sponsor: Riphah International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MANUAL LYMPHATIC DRAINAGE	MANUAL LYMPHATIC DRAINAGE	-
THERAPEUTIC ULTRASOUND	THERAPEUTIC ULTRASOUND	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale - VAS	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
Six Point Engorgement Scale - SPE	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; 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 - BSES	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

Trial Locations

Locations (1)

Innovative Health Concepts Clinic; 🇵🇰 Lahore, Pakistan