Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-06 @ 1:57 PM
Study NCT ID:
NCT06793293
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-27
First Post:
2025-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative in Cesarean Section, the Women Suffering from Pain Due to Wound "incisional Pain", High Level Laser One of Most Effective Methods That Promoting Healing and Decrease Pain so It Will Effective If Use in Decreasing Pain of Cesarian Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'High power level laser used after cesarian section to decrease pain for 3 sessions first, second and third day.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS):', 'timeFrame': 'third day', 'description': 'It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment. The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.'}, {'measure': 'Blood test', 'timeFrame': 'third day', 'description': 'Serum cortisol test (percentage of cortisol level in blood): It will take in the morning for two times one before the intervention or treatment in both groups and another one after 3 days to asses the pain level for patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section pain', 'High power laser', 'decreasing pain', 'Postoperative pain'], 'conditions': ['Cesarean Section Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jphotobiol.2017.05.022', 'label': 'High power laser'}]}, 'descriptionModule': {'briefSummary': "High power laser is safe and effective methods, it's uses increasing one day after day in decreasing pain and promoting healing so its use in postoperative cesarian section will help mothers to overcome pain and return to ADLs faster"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages will be ranged from 20-40 years. 2. Their BMI will be less than 30 Kg\\\\m 2 3. Patients with lower segment cesarean section (Poursalehan et al., 2018 \\& de Holanda et al., 2020).\n\nExclusion Criteria:\n\n* 1\\. Patients with upper segment cesarean section. 2. Diabetic patient. 3. Patient with malignancy, benign tumors with the possibility to become malignant. 4. Infection of the skin (Poursalehan et al., 2018).'}, 'identificationModule': {'nctId': 'NCT06793293', 'briefTitle': 'Postoperative in Cesarean Section, the Women Suffering from Pain Due to Wound "incisional Pain", High Level Laser One of Most Effective Methods That Promoting Healing and Decrease Pain so It Will Effective If Use in Decreasing Pain of Cesarian Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of High Level Laser Therapy on Postoperative Cesarean Section Incisional Pain', 'orgStudyIdInfo': {'id': 'P.T.Rec/012/005570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High level laser', 'description': 'It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) in addition to High level laser for 5 minutes on days 1 st , 2 nd , and 3 rd , after cesarean section (3 sessions)', 'interventionNames': ['Device: High level laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Non-steroidal anti- inflammatory drugs and antibiotics)', 'description': 'It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) only.', 'interventionNames': ['Drug: Non-steroidal anti- inflammatory drugs and antibiotics']}], 'interventions': [{'name': 'High level laser', 'type': 'DEVICE', 'otherNames': ['High power laser'], 'description': 'It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) in addition to High level laser for 5 minutes on days 1 st , 2 nd , and 3 rd , after cesarean section (3 sessions)', 'armGroupLabels': ['High level laser']}, {'name': 'Non-steroidal anti- inflammatory drugs and antibiotics', 'type': 'DRUG', 'description': 'It will be consisted of twenty-five postoperative cesarean section women and will be treated by medical treatment (Non-steroidal anti- inflammatory drugs and antibiotics) only.', 'armGroupLabels': ['(Non-steroidal anti- inflammatory drugs and antibiotics)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teacher assistance at faculty of physical therapy', 'investigatorFullName': 'Aya Ibrahim Awad Shweal', 'investigatorAffiliation': 'Cairo University'}}}}