Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06647420
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2024-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Music Listening on Nursing Students
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heart Rate', 'timeFrame': 'baseline, up to 12 minutes', 'description': 'Heart rate will be measured using the Polar Verity Sense Optical Heart Rate Sensor in beats per minute (bpm)'}, {'measure': 'Change in Skin Conductance', 'timeFrame': 'baseline, up to 12 minutes', 'description': 'Skin conductance will be measured using the NeuLog Galvanic Skin Response (GSR) in micro Siemens (µS).'}, {'measure': 'Change in Anxiety Level', 'timeFrame': 'baseline, up to 12 minutes', 'description': 'The Six Item State-Trait Anxiety Inventory includes six statements that are rated on a 4-point Likert scale (1=Not at all, 2=Somewhat, 3=Moderately so, 4=Very much). The scale will measure current feelings of anxiety.'}], 'secondaryOutcomes': [{'measure': 'The Degree of Stress Experienced by A Nursing Student measured by the Perceived Stress Scale for Nursing Students (PSS) Likert Scale', 'timeFrame': 'up to 5 minutes', 'description': 'The PSS consists of 29 items that are rated on a 5-point Likert scale (1=Never, 2=Seldom, 3=Sometimes, 4=Often, 5=Always). The PSS measures the degree of stress experienced by a nursing student based on stressful factors relevant to the demanding nursing curriculum.'}, {'measure': 'Liking Song Scale (4-point Likert Scale)', 'timeFrame': 'up to 5 minutes', 'description': 'Each music playlist will consist of three songs. The participant will rate how much the participant liked each of the three songs on a 4-point Likert scale (1=Not at all, 2=Somewhat, 3=Moderately so, 4=Very much).'}, {'measure': 'Familiarity Song Scale (Rating scale)', 'timeFrame': 'up to 5 minutes', 'description': "Each music playlist will consist of three songs. The participant will indicate how familiar the participant is with each of the three songs on a rating scale (0=No, 1= I'm not sure, 2=Yes). The results of each song will be added to represent a quasi-continuous variable for how familiar the participant was with the music playlist as a whole."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rate', 'Skin conductance', 'Music'], 'conditions': ['Stress', 'Physiological Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* a senior, junior, or second-semester sophomore in the traditional undergraduate Bachelor of Science in Nursing (BSN) program\n* a student in the accelerated BSN program\n\nExclusion criteria:\n\n•self-reported hearing impairments.'}, 'identificationModule': {'nctId': 'NCT06647420', 'briefTitle': 'The Effect of Music Listening on Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Effect of Sedative and Stimulative Music Listening on State-Anxiety, Heart Rate, and Galvanic Skin Response in Nursing Students', 'orgStudyIdInfo': {'id': '20241018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedative music followed by stimulative music group', 'description': 'The participants in this group will receive sedative music followed by stimulative music for up to 25 minutes each. Session two will occur two days after session one.', 'interventionNames': ['Behavioral: Sedative Music', 'Behavioral: Stimulative Music']}, {'type': 'EXPERIMENTAL', 'label': 'Stimulative music followed by sedative music group', 'description': 'The participants in this group will receive stimulative music followed by sedative music for up to 25 minutes each. Session two will occur two days after session one.', 'interventionNames': ['Behavioral: Sedative Music', 'Behavioral: Stimulative Music']}], 'interventions': [{'name': 'Sedative Music', 'type': 'BEHAVIORAL', 'description': 'The participants will come twice in person and listen to 9 minutes of sedative music.', 'armGroupLabels': ['Sedative music followed by stimulative music group', 'Stimulative music followed by sedative music group']}, {'name': 'Stimulative Music', 'type': 'BEHAVIORAL', 'description': 'The participants will come twice in person and listen to 9 minutes of stimulative music.', 'armGroupLabels': ['Sedative music followed by stimulative music group', 'Stimulative music followed by sedative music group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Nursing and Health Studies', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Weeks Music Library and Technology Center', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Teresa Lesiuk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Teresa Lesiuk', 'investigatorAffiliation': 'University of Miami'}}}}