PostpartumNCT06168630
Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.
A study testing Manual lymph drainage in people with Postpartum, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Postpartum
- What is being tested?
- Manual lymph drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2023to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.
- Women with breast cancer. Women with breast abcess. Women taking other medications.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International university, Lahore
Lahore, Punjab Province
Adeela Arif, Mphil, 03320845723, adeela.arif@riphah.edu.pk
About this study
Official title: Effects of Manual Lymph Drainage on Breast Engorgement, Pain and Self Efficacy in Postpartum Period.
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.
Read the 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.
- Conditions
- Postpartum
- Being tested
- Manual lymph drainage, Control group
- Keywords
- Engorgement, Manual lymph drainage, Postpartum period, Pain, Self efficacy
- Medical subject headings
- Hyperemia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymph drainageOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymph Drainage | Experimental | Not described Receives: Other: Manual lymph drainage |
| Control group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start5 Apr 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeela Arif, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168630
- Sponsor's protocol ID
- Aqsa Ejaz
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 37679918Manna 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Lymph Drainage on Breast Engorgement, Pain and Self Efficacy in Postpartum Period.
- ClinicalTrials.gov ID
- NCT06168630
- Acronym / sponsor ID
- Aqsa Ejaz
- Conditions
- Postpartum
- Keywords
- Engorgement, Manual lymph drainage, Postpartum period, Pain, Self efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lymph Drainage | Experimental | Other: Manual lymph drainage |
| Control group | Other | Other: Control group |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.
- Women with breast cancer. Women with breast abcess. Women taking other medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual lymph drainageIt 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 . | Other | Manual Lymph Drainage |
| Control groupThe 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. | Other | Control group |
Primary outcome
Numerical pain rating scale
Time frame: 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
Six point self rated engorgement scale
Time frame: 5th day
Six point self rated engorgemet scale is valid and reliable measures to assess breast engorgement and pain
Breast feeding self efficacy questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- BackgroundMonazzami 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: PubMed 37679918Song 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.
- BackgroundManna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymph drainage in people with Postpartum, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: 5th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168630, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.