Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:48 PM
Study NCT ID:
NCT07452861
Status:
COMPLETED
Last Update Posted:
2026-03-09
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ney Music During Non-Stress Test and Maternal Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety (STAI-S Score)', 'timeFrame': 'Immediately before NST and immediately after NST (20 minutes)', 'description': 'Change in maternal state anxiety measured using the State-Trait Anxiety Inventory-State (STAI-S) before and immediately after the non-stress test (NST).'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure (mmHg)', 'timeFrame': 'Before and immediately after NST (20 minutes)'}, {'measure': 'Diastolic Blood Pressure (mmHg)', 'timeFrame': 'Before and immediately after NST (20 minutes)'}, {'measure': 'Heart Rate (beats per minute)', 'timeFrame': 'Before and immediately after NST (20 minutes)'}, {'measure': 'Respiratory Rate (breaths per minute)', 'timeFrame': 'Before and immediately after NST (20 minutes)'}, {'measure': 'Oxygen Saturation (%)', 'timeFrame': 'Before and immediately after NST (20 minutes)'}, {'measure': 'NST Reactivity (Reactive vs Non-reactive)', 'timeFrame': 'During 20-minute NST session'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-stress test', 'music intervention', 'maternal anxiety', 'autonomic regulation', 'fetal reactivity', 'ney music'], 'conditions': ['Maternal Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. A total of 126 pregnant women at ≥32 weeks' gestation were randomly assigned to either an intervention group (ney music during NST) or a control group (standard NST care). Maternal state anxiety (State-Trait Anxiety Inventory-State), perceived stress and anxiety (DASS-21), blood pressure, heart rate, respiratory rate, oxygen saturation, and NST reactivity were assessed before and after the procedure. The primary objective is to determine whether ney music reduces acute maternal state anxiety during NST. Secondary objectives include evaluating its effects on autonomic physiological parameters and fetal NST reactivity."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria were:\n\n* age ≥18 years,\n* gestational age ≥32 weeks,\n* singleton pregnancy,\n* absence of known fetal cardiovascular anomalies,\n* no visual or hearing impairments,\n* having eaten at least two hours before the NST,\n* bladder emptied prior to the procedure,\n* voluntary participation.\n\nExclusion criteria included:\n\n* pre-existing maternal medical conditions (hypertension, diabetes, obesity),\n* multiple pregnancy,\n* smoking,\n* known fetal abnormalities or fetal distress,\n* inherited anemia or sexually transmitted infections.'}, 'identificationModule': {'nctId': 'NCT07452861', 'briefTitle': 'Ney Music During Non-Stress Test and Maternal Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'Effect of Ney Music During the Non-Stress Test on Maternal State Anxiety, Autonomic Regulation, and Fetal Reactivity: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023/016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ney Music During NST', 'description': 'Pregnant women listened to ney music ("Aşkın Yolculuğu") via headphones for 20 minutes during routine non-stress testing (NST).', 'interventionNames': ['Behavioral: Ney Music']}, {'type': 'NO_INTERVENTION', 'label': 'Standard NST (No Music)', 'description': 'No Intervention'}], 'interventions': [{'name': 'Ney Music', 'type': 'BEHAVIORAL', 'description': 'Listening to prerecorded ney music through headphones during the 20-minute NST procedure.', 'armGroupLabels': ['Ney Music During NST']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'KTO Karatay University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hediye Karakoç', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'KTO Karatay University', 'investigatorFullName': 'Hediye Karakoç', 'investigatorAffiliation': 'KTO Karatay University'}}}}