Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT05966766
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2023-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dosing Music for Anxiety Reduction in Parturients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dan.drzymalski@tuftsmedicine.org', 'phone': '617-913-8168\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c\u202c', 'title': 'Dan Drzymalski, MD', 'organization': 'Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Minimum required number of participants recruited was achieved. Larger sample sizes may have yielded results of stronger statistical significance.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Mozart', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.\n\nMozart selections: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patient Preference', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.\n\nPatient-preferred music selections: Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mozart', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.'}, {'id': 'OG001', 'title': 'Patient Preference', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.'}], 'classes': [{'title': 'Before', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'After', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 minutes', 'description': 'Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'STAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mozart', 'description': 'Subjects in this arm listened to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.'}, {'id': 'OG001', 'title': 'Patient Preference', 'description': 'Subjects in this arm listened to music from a list of pre-selected pieces of their own choosing.'}], 'classes': [{'title': 'Before', 'categories': [{'measurements': [{'value': '12.7', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'After', 'categories': [{'measurements': [{'value': '10.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-8 minutes', 'description': '6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mozart', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.'}, {'id': 'FG001', 'title': 'Patient Preference', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mozart', 'description': 'Subjects in this arm listened to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.'}, {'id': 'BG001', 'title': 'Patient Preference', 'description': 'Subjects in this arm listened to music from a list of pre-selected pieces of their own choosing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gravidity', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '3', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Births', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Number of individuals grouped by intervention received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-31', 'size': 830073, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-10T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-07-20', 'resultsFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-13', 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Score', 'timeFrame': '4-8 minutes', 'description': 'Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome.'}], 'secondaryOutcomes': [{'measure': 'STAI', 'timeFrame': '4-8 minutes', 'description': '6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'This is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. It will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. Methods will involve enrolling and playing music for patients awaiting scheduled C-section, and scoring their anxiety with pre- and post-music questionnaires. Music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which 95% of subjects should have a positive response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Planning on scheduled cesarean section or non-emergent unscheduled cesarean section\n* Able to provide informed consent\n* American Society of Anaesthesiologists (ASA) physical status score of II-III\n\nExclusion Criteria:\n\n* Patient refusal\n* Impaired hearing\n* Patient is taking at least one anxiolytic medication daily at baseline\n* No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given\n* ASA IV or higher'}, 'identificationModule': {'nctId': 'NCT05966766', 'briefTitle': 'Dosing Music for Anxiety Reduction in Parturients', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Cesarean Delivery', 'orgStudyIdInfo': {'id': '00003958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mozart', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.', 'interventionNames': ['Other: Mozart selections']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient preference', 'description': 'Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.', 'interventionNames': ['Other: Patient-preferred music selections']}], 'interventions': [{'name': 'Mozart selections', 'type': 'OTHER', 'description': 'Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.', 'armGroupLabels': ['Mozart']}, {'name': 'Patient-preferred music selections', 'type': 'OTHER', 'description': 'Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.', 'armGroupLabels': ['Patient preference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Dan Drzymalski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}