NCT06168630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 4, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

EngorgementManual lymph drainagePostpartum periodPainSelf efficacy

Outcome Measures

Primary Outcomes (3)

  • Numerical pain rating scale

    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

    5th day

  • Six point self rated engorgement scale

    Six point self rated engorgemet scale is valid and reliable measures to assess breast engorgement and pain

    5th day

  • Breast feeding self efficacy questionnaire

    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

    5th day

Study Arms (2)

Manual Lymph Drainage

EXPERIMENTAL
Other: Manual lymph drainage

Control group

OTHER
Other: Control group

Interventions

It consists of patients who will receive manual lymph drainage everyday for 5 days. The subject's position will be supine with their knees bent. Every session will be of 45 minutes. Manual lymph drainage will with abdominal lymph drainage, after which central lymph stimulation will be performed. Then, by stimulating the bilateral axillary lymph nodes, the flow of fluid over the right and left breasts will be directed toward the axillary lymph nodes. While the patients in the prone position, bilateral axillary lymph nodes will be stimulated, and each manual lymph drainage will be performed from the dorsum to the axillary lymph node .

Manual Lymph Drainage

The other group will receive massage for 20 minutes every day for 5 days from first day of treatment. Massage will be done using the index and middle fingers in a spiral motion towards the nipples.

Control group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.
  • Women with breast cancer. Women with breast abcess. Women taking other medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university, Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

  • Monazzami M, Yousefzadeh S, Rakhshandeh H, Esmaeili H, Afiat M. The effect of hot ginger compress (Zingiber officinale) on the severity of breast engorgement in lactating women. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2019;21(12):77-84.

    BACKGROUND
  • Song JA, Hur MH. A Systematic Review of Breast Care for Postpartum Mothers. Korean J Women Health Nurs. 2019 Sep;25(3):258-272. doi: 10.4069/kjwhn.2019.25.3.258. Epub 2019 Sep 2.

    PMID: 37679918BACKGROUND
  • Manna M, Podder L, Devi S. Effectiveness of hot fomentation versus cold compression on breast engorgement among postnatal mothers. International Journal of Nursing Research and Practice. 2016;3(1):13-8.

    BACKGROUND

MeSH Terms

Conditions

HyperemiaPain

Interventions

Manual Lymphatic DrainageControl Groups

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 13, 2023

Study Start

April 5, 2023

Primary Completion

January 1, 2024

Study Completion

January 10, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations