Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06499402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stress', 'timeFrame': '1 day', 'description': 'questionnaire, stress scale'}], 'secondaryOutcomes': [{'measure': 'labor pain', 'timeFrame': '1 day', 'description': 'pain scale, VAS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain', 'Labor']}, 'descriptionModule': {'briefSummary': 'Our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers\' labor pain, perception, process and midwives\' satisfaction. The research was planned as a randomized controlled experimental study. A total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. In this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. Pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "Individual Identification Form", "Visual Comparison Scale", "Labor Monitoring Form", "Mother\'s Birth Perception Scale (ADAS)". The satisfaction of midwives will be evaluated with the "Evaluation of Satisfaction Status of Midwives Form".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '45 Days', 'minimumAge': '18 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating in the study voluntarily\n* having a cervical dilatation of 5-6 cm,\n* being between 38-40 weeks of pregnancy,- being a single fetus, having a cephalic presentation,\n* having a fetal weight between 2.5-4 kg,\n* having no vision-hearing problems,\n* having communication and cooperation skills\n\nExclusion Criteria:\n\n* having pregnancy complications\n* Those who have acute inflammatory problems in soft tissues, skin or joints, burns, nerve injuries, open wounds, rheumatoid and gouty arthritis,\n* those who have used any non-pharmacological methods will not be admitted.'}, 'identificationModule': {'nctId': 'NCT06499402', 'briefTitle': "The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction", 'organization': {'class': 'OTHER', 'fullName': 'Osmaniye Korkut Ata University'}, 'officialTitle': "The Effect of Pregnant-controlled Sacral Massage on Mothers' Labor Pain, Perception, Process and Midwives' Satisfaction", 'orgStudyIdInfo': {'id': '12345678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group'}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Other: massage']}], 'interventions': [{'name': 'massage', 'type': 'OTHER', 'description': 'sacral massage', 'armGroupLabels': ['experimental group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osmaniye Korkut Ata University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emine Yıldırım', 'investigatorAffiliation': 'Osmaniye Korkut Ata University'}}}}