MedDataX Logo

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

NCT ID: NCT06168630

Last Updated: 2023-12-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2024-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Engorgement Manual lymph drainage Postpartum period Pain Self efficacy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual Lymph Drainage

Group Type EXPERIMENTAL

Manual lymph drainage

Intervention Type OTHER

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 .

Control group

Group Type OTHER

Control group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual lymph drainage

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 .

Intervention Type OTHER

Control group

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

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

Women with breast cancer. Women with breast abcess. Women taking other medications.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adeela Arif

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah International university, Lahore

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adeela Arif, Mphil

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 37679918 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Aqsa Ejaz

Identifier Type: -

Identifier Source: org_study_id