Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.

Not Applicable

Recruiting

• Conditions: Postpartum
• Interventions: Other: Manual lymph drainage; Other: Control group

• Registration Number: NCT06168630
• Lead Sponsor: Riphah International University

Brief Summary

There have been many studies on the treatment of breast engorgement, there is a lack of research comparing the effectiveness of manual lymph drainage with massage. Therefore, this study will be a randomized controlled trial that aims to compare the effects of manual lymph drainage with massage on breast engorgement, pain, and self efficacy in the postpartum period.

Detailed Description

The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling technique will be used and 35 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive manual lymph drainage and group B will receive massage whereas cold pack will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are NPRS, 6 point self rated engorgement scale and breast feeding self efficacy questionnaire. The data will be assessed after 5 days of treatment using 2 tailed t test. After data collection data will be analyzed by using SPSS version 25.

Study Timeline

• Study Start: 2023-04-05
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Women aged 25 to 35 years. Lactating mothers who presents with breast pain after birth. Women with breast heaviness. Women who rate themselves 4 on engorgement scale on six-point self-rated engorgement scale.

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Exclusion Criteria

Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.

Women with breast cancer. Women with breast abcess. Women taking other medications.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Lymph Drainage	Manual lymph drainage	-
Control group	Control group	-

Primary Outcome Measures

Name	Time	Method
Six point self rated engorgement scale	5th day	Six point self rated engorgemet scale is valid and reliable measures to assess breast engorgement and pain
Numerical pain rating scale	5th day	The Numerical pain rating scale is the most commonly used pain scale in the health care.; This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10
Breast feeding self efficacy questionnaire	5th day	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). BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy

Trial Locations

Locations (1)

Riphah International university, Lahore; 🇵🇰 Lahore, Punjab, Pakistan