Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-27 @ 3:07 AM
Study NCT ID:
NCT04620850
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the duration of the first time to flatus passage in post cesaren section patient', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the duration ; hour after post cesaren section'}], 'secondaryOutcomes': [{'measure': 'To study the duration of the first time to have bowel sound in post cesaren section patient', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the duration ; hour after post cesaren section'}, {'measure': 'To study the duration of the first time to pass stool in post cesaren section patient', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the duration ; hour after post cesaren section'}, {'measure': 'To study the symptomatic about Nausea/vomiting in post cesaren section patient', 'timeFrame': 'mild', 'description': 'Score; mild,moderate,severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupressure', 'Post-Op Complication', 'Cesarean Section', 'Bowel Ileus']}, 'descriptionModule': {'briefSummary': 'Research objectives To compare the efficacy of acupressure with no acupressure to examine time to first flatus in patient post cesarean section\n\n; Acupressure at ST-36 Zusanli (lateral to anterior crest of tibia, in the tibialis anterior muscle)\n\nResearch hypothesis Patients who received acupressure will have earlier flatus passage', 'detailedDescription': 'Research design Randomized controlled trial. Compare between The investigators is who assess the acupressure with control group is the participants do not assess the acupressure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnancy woman age 18-45 years\n2. General anesthesia\n3. Co-operate in research\n4. Can speak in thai language\n\nExclusion Criteria:\n\n1. Twin pregnancy\n2. Placenta previa\n3. Placental abruption\n4. Chorioamnionitis\n5. Complication intraoperation (Bowel or bladder injury)\n6. Post partum hemorrhage\n7. Abdominal adhesion\n8. Opertative time more than 2 hour\n9. History gastrointestinal surgery\n10. Prior acupressure\n11. Neurological disease\n12. Neuromuscular disease\n13. Hepatic disease'}, 'identificationModule': {'nctId': 'NCT04620850', 'briefTitle': 'Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section', 'orgStudyIdInfo': {'id': '165/2563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupressure', 'description': 'Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time) Acupressure at below knee the point ai locate about4 finger spcae below patella on the lateral side of tibia bone', 'interventionNames': ['Device: Acupressure']}, {'type': 'NO_INTERVENTION', 'label': 'No acupressure', 'description': 'Standard post-operative care'}], 'interventions': [{'name': 'Acupressure', 'type': 'DEVICE', 'description': 'Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)', 'armGroupLabels': ['Acupressure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sasiwimol kunnitikorn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}