Postpartum ComplicationNCT06303232
Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement
A study testing MANUAL LYMPHATIC DRAINAGE and THERAPEUTIC ULTRASOUND in people with Postpartum Complication, run by Riphah International University at 1 site in Pakistan.
Trial summary
To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Postpartum Complication
- What is being tested?
- MANUAL LYMPHATIC DRAINAGE and THERAPEUTIC ULTRASOUND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2023to 19 Aug 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women
To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.
- Conditions
- Postpartum Complication
- Being tested
- MANUAL LYMPHATIC DRAINAGE, THERAPEUTIC ULTRASOUND
- Keywords
- Breast engorgement, manual lymphatic drainage, therapeutic ultrasound, pain, self-efficacy, post - partum women.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANUAL LYMPHATIC DRAINAGEOther
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 ULTRASOUNDOther
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
| Study group | Role | What they receive |
|---|---|---|
| MANUAL LYMPHATIC DRAINAGE | Experimental | Not described Receives: Other: MANUAL LYMPHATIC DRAINAGE |
| THERAPEUTIC ULTRASOUND | Active comparator | Not described Receives: Other: THERAPEUTIC ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale - VAS
VAS is an effective rule is measuring the pain score. It ranges from 0 -10 cm line scale with the following description; 0 cm = no pain
1 - 3 cm = mild pain 4 - 7 cm = moderate pain 8 - 10 cm = severe pain (20). When assessing the validity of VAS, a good-to-excellent correlation was found (r = 0.941), this scale had excellent test-retest reliability. The intra - class correlation coefficients of the VAS was 0.97
Measured: 7th day
Six Point Engorgement Scale - SPE
Six point engorgement scale was the scale for the determination of the breast engorgement.
The reliability of tool engorgement was 0.948 (22). The score of this scale ranges from 1 - 6.
Every score has a following description;
- = no changes in breast / soft breast
- = slight changes in breast
- = firm but no breast tenderness
- = firm with starting breast tenderness
- = tender and firm
- = very tender and very firm
Measured: 7th day
Breastfeeding Self-Efficacy Scale - BSES
It includes the 14 items that measure the confidence of the breastfeeding. 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). In sum, BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Feb 2023
- Primary completion1 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum ComplicationStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul gul, phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303232
- Sponsor's protocol ID
- REC/RCR&AHS/23/0578
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32283875Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.
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.
Indrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023
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
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women
- ClinicalTrials.gov ID
- NCT06303232
- Acronym / sponsor ID
- REC/RCR&AHS/23/0578
- Conditions
- Postpartum Complication
- Keywords
- Breast engorgement, manual lymphatic drainage, therapeutic ultrasound, pain, self-efficacy, post - partum women.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 12 Mar 2024 (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.
To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MANUAL LYMPHATIC DRAINAGE | Experimental | Other: MANUAL LYMPHATIC DRAINAGE |
| THERAPEUTIC ULTRASOUND | Active comparator | Other: THERAPEUTIC ULTRASOUND |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 LYMPHATIC DRAINAGEMLD 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 | Other | MANUAL LYMPHATIC DRAINAGE |
| THERAPEUTIC ULTRASOUNDThe 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 | Other | THERAPEUTIC ULTRASOUND |
Primary outcome
Visual Analogue Scale - VAS
Time frame: 7th day
VAS is an effective rule is measuring the pain score. It ranges from 0 -10 cm line scale with the following description; 0 cm = no pain 1 - 3 cm = mild pain 4 - 7 cm = moderate pain 8 - 10 cm = severe pain (20). When assessing the validity of VAS, a good-to-excellent correlation was found (r = 0.941), this scale had excellent test-retest reliability. The intra - class correlation coefficients of the VAS was 0.97
Six Point Engorgement Scale - SPE
Time frame: 7th day
Six point engorgement scale was the scale for the determination of the breast engorgement. The reliability of tool engorgement was 0.948 (22). The score of this scale ranges from 1 - 6. Every score has a following description; 1. = no changes in breast / soft breast 2. = slight changes in breast 3. = firm but no breast tenderness 4. = firm with starting breast tenderness 5. = tender and firm 6. = very tender and very firm
Breastfeeding Self-Efficacy Scale - BSES
Time frame: 7th day
It includes the 14 items that measure the confidence of the breastfeeding. 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). In sum, BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 32283875Lyons 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.
- BackgroundMitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.
- BackgroundNapisah 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.
- BackgroundIndrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023
- BackgroundAprilina 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
- BackgroundZutshi 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.
- BackgroundVarghese 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.
- Individual participant dataSharing planned: No
Related trials for Postpartum Complication
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
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.
hina gul gul, phd* principal investigator
Riphah International University
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 LYMPHATIC DRAINAGE and THERAPEUTIC ULTRASOUND in people with Postpartum Complication, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 4 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale - VAS (time frame: 7th 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 NCT06303232, which also lists 7 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 4 Sep 2024.