Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

NCT ID: NCT06303232

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2024-08-19

Brief Summary

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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

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Conditions

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Postpartum Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MANUAL LYMPHATIC DRAINAGE

Group Type EXPERIMENTAL

MANUAL LYMPHATIC DRAINAGE

Intervention Type 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

Group Type ACTIVE_COMPARATOR

THERAPEUTIC ULTRASOUND

Intervention Type 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

Interventions

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MANUAL 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

Intervention Type OTHER

THERAPEUTIC 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hina gul gul, phd*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Innovative Health Concepts Clinic

Lahore, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 32283875 (View on PubMed)

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

Reference Type 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.

Reference Type 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

Reference Type 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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

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REC/RCR&AHS/23/0578

Identifier Type: -

Identifier Source: org_study_id

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