Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-28 @ 6:11 AM
Study NCT ID:
NCT06303232
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2024-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale - VAS', 'timeFrame': '7th day', 'description': '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\n\n1 - 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'}, {'measure': 'Six Point Engorgement Scale - SPE', 'timeFrame': '7th day', 'description': 'Six point engorgement scale was the scale for the determination of the breast engorgement.\n\nThe reliability of tool engorgement was 0.948 (22). The score of this scale ranges from 1 - 6.\n\nEvery score has a following description;\n\n1. = no changes in breast / soft breast\n2. = slight changes in breast\n3. = firm but no breast tenderness\n4. = firm with starting breast tenderness\n5. = tender and firm\n6. = very tender and very firm'}, {'measure': 'Breastfeeding Self-Efficacy Scale - BSES', 'timeFrame': '7th day', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast engorgement', 'manual lymphatic drainage', 'therapeutic ultrasound', 'pain', 'self-efficacy', 'post - partum women.'], 'conditions': ['Postpartum Complication']}, 'referencesModule': {'references': [{'pmid': '32283875', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. Breastfeeding: Elsevier; 2022. p. 572-93.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Indrani D, Sowmya M. A study to find the prevalence of breast engorgement among lactating Mothers. J Reprod Med Gynecol Obstet. 2019;4:023'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'POST - PARTUM WOMEN', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both primiparous or multiparous breastfeeding women\n* BMI: ≤30-≥25 (14)\n* Immediate puerperium with normal or C - section non-premature childbirth (19)\n* Postnatal lactating mother with symptoms of breast engorgement\n\nExclusion Criteria:\n\n* any breast infection, abscess, mastitis, breast cancer\n* torn/bleeding or crack nipples\n* any skin condition like dermatitis, psoriasis etc\n* non-lactating mothers\n* having heart pacemaker'}, 'identificationModule': {'nctId': 'NCT06303232', 'briefTitle': 'Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0578'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MANUAL LYMPHATIC DRAINAGE', 'interventionNames': ['Other: MANUAL LYMPHATIC DRAINAGE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THERAPEUTIC ULTRASOUND', 'interventionNames': ['Other: THERAPEUTIC ULTRASOUND']}], 'interventions': [{'name': 'MANUAL LYMPHATIC DRAINAGE', 'type': 'OTHER', 'description': '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.\n\nThen, 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', 'armGroupLabels': ['MANUAL LYMPHATIC DRAINAGE']}, {'name': 'THERAPEUTIC ULTRASOUND', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['THERAPEUTIC ULTRASOUND']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05499', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Innovative Health Concepts Clinic', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'hina gul gul, phd*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}