Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-10 @ 8:12 PM
Study NCT ID:
NCT06496932
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music for Anxiety Management in Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiete level', 'timeFrame': '37th gestational weeks]', 'description': 'State-Trait Anxiety Inventory: It can be applied to individuals over the age of 14. It consists of 20 items that determine how an individual feels at a certain moment and under certain conditions. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person filling out the inventory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section', 'music', 'randomize trial'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.', 'detailedDescription': 'It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Aged between 18-35 years,\n\n* Undergoing cesarean section under spinal anesthesia,\n* Experiencing spontaneous and singleton pregnancy,\n* With a gestational age greater than 37 weeks,\n* Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,\n* Scheduled for cesarean section (regardless of the number of previous cesarean sections).\n\nExclusion Criteria:\n\n* Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason'}, 'identificationModule': {'nctId': 'NCT06496932', 'briefTitle': 'Music for Anxiety Management in Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Management of Anxiety and Vital Signs With Music in Cesarean Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Interventional trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Listen to music group', 'description': 'The study group will be played music during the cesarean section.', 'interventionNames': ['Other: Listen to music']}, {'type': 'NO_INTERVENTION', 'label': 'Standart cesarean procedure', 'description': 'The control group continued to receive the routine care'}], 'interventions': [{'name': 'Listen to music', 'type': 'OTHER', 'description': 'Women in the intervention groups will listen to nature and bird sounds through over-the-ear headphones after spinal anesthesia for cesarean section until the suturing is completed.', 'armGroupLabels': ['Listen to music group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Adnan Menderes University', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Tuğba Dündar', 'role': 'STUDY_CHAIR', 'affiliation': 'AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Tuğba Dündar', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}