Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-26 @ 6:15 AM
Study NCT ID:
NCT06166732
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Music-Based Mindfulness to Cope with Acculturative-Related Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Spielberger State-Anxiety Inventory', 'timeFrame': '5 minutes before intervention and 5 minutes post intervention', 'description': "The Spielberger State-Trait Anxiety Inventory survey which has six-item short-form of the state(STAI: Y-6 score.\n\nTo calculate the total STAI score (range 20 - 80):\n\n* reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1;\n* sum all six scores;\n* multiply total score by 20/6;\n* refer to Spielberger's manuals to interpret scores (a 'normal' score is approx. 34 - 36) Participant will complete the survey 5 minutes prior to the intervention and then 5 minutes after the intervention"}, {'measure': 'Change in researcher-designed attention scale', 'timeFrame': '5 minutes before intervention and 5 minutes post intervention', 'description': 'There are two items. The first item "I am very focused in the present right now" will utilize a 5-point scale ranging from 1= "Not at All" to 5= "Extremely." Conversely, the second item "I have a lot of distracting thoughts right now" will be measured using a reversed score. In this context, higher scores signify greater levels of attention. A composite score of these two items will be reported.'}, {'measure': 'Change in Trail Making Test, Part A and B', 'timeFrame': '5 minutes before intervention and 5 minutes post intervention', 'description': 'The Trail Making Test (TMT) is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds.\n\nThe present study reports T-scores, which can range from a minimum of 0 and a maximum of 100. The higher the T- score achieved by a participant, the better the performance, indicating a higher level of functioning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international students.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years of age or older\n* Pursuing an undergraduate/graduate degree with an F-1 visa\n* Originating from regions including China, Hong Kong, Taiwan, North Korea, South Korea, and Japan\n* Living in the United States for no more than 3 years\n* Having less than one year of mindfulness practice\n\nExclusion Criteria:\n\n• Individuals not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06166732', 'briefTitle': 'The Effect of Music-Based Mindfulness to Cope with Acculturative-Related Stress', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Effect of Music-Based Mindfulness on Acculturative Stress and Attention in East Asian International Students', 'orgStudyIdInfo': {'id': '20231114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music-based Mindfulness Group', 'description': 'Participants will receive a music-based mindfulness for 20 minutes.', 'interventionNames': ['Behavioral: Music-based Mindfulness']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants will receive a information session for 20 minutes.', 'interventionNames': ['Behavioral: Control Group']}], 'interventions': [{'name': 'Music-based Mindfulness', 'type': 'BEHAVIORAL', 'description': 'The participants will receive a single 20-minute music-based mindfulness session in person. The participants will listen to instrumental music during the session.', 'armGroupLabels': ['Music-based Mindfulness Group']}, {'name': 'Control Group', 'type': 'BEHAVIORAL', 'description': 'The participants will receive a single 20-minute information session in person. The information session will introduce the definition, history, basic concepts, and benefits of mindfulness practice.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Volpe 206', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Teresa Lesiuk, Ph.D.', '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'}}}}