Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
Study NCT ID:
NCT06755268
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2024-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Music on Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014919', 'term': 'Wind'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D000392', 'term': 'Air Movements'}, {'id': 'D055907', 'term': 'Climatic Processes'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D059205', 'term': 'Renewable Energy'}, {'id': 'D004736', 'term': 'Energy-Generating Resources'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D000388', 'term': 'Air'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamic Parameters Record Form', 'timeFrame': 'before the angiography procedure and after the angiography procedure (average of 15 minutes)', 'description': 'The form was used to record the Systolic Blood Pressure (mm/Hg), Diastolic Blood Pressure (mm/Hg), Respiratory Rate, Heart Rate (Pulse) (atm/min) and Saturation parameters measured before and after the angiography procedure of the intervention and control groups.\n\nSystolic blood pressure measurements were averaged. Diastolic blood pressure measurements were averaged. Saturation measurements were averaged. Respiratory rate measurements were averaged. Heart Rate (Pulse) measurements were averaged.'}], 'primaryOutcomes': [{'measure': 'General Comfort Scale', 'timeFrame': 'before the angiography procedure and after the angiography procedure (average of 15 minutes)', 'description': 'Scores from the scale range from 48 to 192, and the higher the score, the higher the comfort level.'}], 'secondaryOutcomes': [{'measure': 'State Anxiety Scale', 'timeFrame': 'before the angiography procedure and after the angiography procedure (average of 15 minutes)', 'description': 'Scores from the scale range from 20 to 80, and the higher the score, the higher the anxiety level.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Comfort', 'Coronary angiography', 'Hemodynamic parameters', 'Nursing'], 'conditions': ['Coronary Angiography', 'Hemodynamic Parameters', 'Comfort', 'Anxiety', 'Music Intervention']}, 'descriptionModule': {'briefSummary': 'This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n* Being at least literate\n* Having no mental and cognitive competence\n* Understanding and speaking Turkish\n* Having a planned coronary angiography\n* Performing for diagnostic purposes\n\nExclusion Criteria:\n\n* Having visual and hearing impairment\n* Having a psychiatric diagnosis\n* Using psychiatric medication (tranquilizers, etc.)\n* Using anxiety medication in the last 6 months\n* Having had coronary angiography before\n* The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)\n* An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)\n* coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure\n* Data collection forms were not filled out by the participant after coronary angiography'}, 'identificationModule': {'nctId': 'NCT06755268', 'briefTitle': 'Effect of Music on Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effect of Music on Comfort, Anxiety and Hemodynamic Parameters During Coronary Angiography', 'orgStudyIdInfo': {'id': 'E-77082166-302.08.01-850481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Application Group', 'description': 'After explaining the purpose of the study and the way it was applied to patients in the music group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. The intervention group listened to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.Music was played to the intervention group via a loudspeaker placed in the coronary angiography laboratory.The intervention group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.', 'interventionNames': ['Other: listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'After explaining the purpose of the study and the way it was applied to patients in the control group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. No application was be made to the control group. The control group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.'}], 'interventions': [{'name': 'listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music', 'type': 'OTHER', 'description': 'Listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.', 'armGroupLabels': ['Application Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Özlem Canbolat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Özlem Canbolat', 'investigatorAffiliation': 'Gazi University'}}}}