Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05171218
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Music & Auditory Beat Stimulation on Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-18', 'size': 150362, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-26T16:54', 'hasProtocol': True}, {'date': '2021-03-18', 'size': 504073, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-26T16:57', 'hasProtocol': False}, {'date': '2021-03-18', 'size': 244665, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-26T16:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Participants taking anxiolytics (n = 163) were randomly assigned to a single 24- minute session of sound-based treatment: combined (Music with theta auditory beat stimulation), music-alone, theta auditory beat stimulation-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-11-27', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)', 'timeFrame': '24 minutes', 'description': 'The State Trait Anxiety Inventory for Cognitive and Somatic Anxiety has good reliability and validity as a measure of state and trait cognitive and somatic anxiety. The minimum score is 10 and the maximum is 40. Higher scores indicate higher anxiety (worse outcome). But in this study the post-intervention anxiety score is subtracted from the pre-intervention anxiety score, giving a measure of anxiety reduction. In the case of this anxiety reduction measure, higher anxiety reduction scores would indicate a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Mood: Positive and Negative Affect Scale (PANAS)', 'timeFrame': '24 minutes', 'description': 'The Positive and Negative Affect Scale has good reliability and validity and has been widely used in many studies to assess mood. This scale generates two scores: 1) Positive affect (higher score indicates a better outcome), scores range from 10-50. 2) Negative affect (higher score indicates worse outcome), scores range from 10-50.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Auditory Beat Stimulation', 'Binaural Beats', 'Mental Health', 'Music', 'Neuroscience', 'Psychology'], 'conditions': ['Anxiety']}, 'referencesModule': {'availIpds': [{'url': 'https://osf.io/efya2/', 'type': 'Individual Participant Data Set'}, {'url': 'https://doi.org/10.17605/OSF.IO/VHCA5', 'type': 'Study Protocol'}, {'url': 'https://doi.org/10.17605/OSF.IO/VHCA5', 'type': 'Statistical Analysis Plan'}, {'url': 'https://osf.io/efya2/', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '20954057', 'type': 'BACKGROUND', 'citation': 'Bados A, Gomez-Benito J, Balaguer G. The state-trait anxiety inventory, trait version: does it really measure anxiety? J Pers Assess. 2010 Nov;92(6):560-7. doi: 10.1080/00223891.2010.513295.'}, {'type': 'BACKGROUND', 'citation': 'Gray EK, Watson, D. Assessing positive and negative affect via self-report. In: Coan JA, Allen, J.J.B., editor. Handbook of emotion elicitation and assessment. New York, NY: Oxford University Press; 2007.'}, {'pmid': '18085930', 'type': 'BACKGROUND', 'citation': 'Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.'}, {'pmid': '33418360', 'type': 'BACKGROUND', 'citation': 'Phillips SP, Yu J. Is anxiety/depression increasing among 5-25 year-olds? A cross-sectional prevalence study in Ontario, Canada, 1997-2017. J Affect Disord. 2021 Mar 1;282:141-146. doi: 10.1016/j.jad.2020.12.178. Epub 2020 Dec 30.'}, {'pmid': '3397865', 'type': 'BACKGROUND', 'citation': 'Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.'}, {'type': 'BACKGROUND', 'citation': 'Davis WB, Thaut MH. The Influence of Preferred Relaxing Music on Measures of State Anxiety, Relaxation, and Physiological Responses. Journal of Music Therapy. 1989;26(4):168-87. doi: 10.1093/jmt/26.4.168.'}, {'pmid': '28325532', 'type': 'BACKGROUND', 'citation': 'Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.'}, {'pmid': '25452734', 'type': 'BACKGROUND', 'citation': 'McConnell PA, Froeliger B, Garland EL, Ives JC, Sforzo GA. Auditory driving of the autonomic nervous system: Listening to theta-frequency binaural beats post-exercise increases parasympathetic activation and sympathetic withdrawal. Front Psychol. 2014 Nov 14;5:1248. doi: 10.3389/fpsyg.2014.01248. eCollection 2014.'}, {'pmid': '16115248', 'type': 'BACKGROUND', 'citation': 'Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.'}, {'pmid': '17309374', 'type': 'BACKGROUND', 'citation': 'Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196.'}, {'pmid': '31977827', 'type': 'BACKGROUND', 'citation': 'Yusim A, Grigaitis J. Efficacy of Binaural Beat Meditation Technology for Treating Anxiety Symptoms: A Pilot Study. J Nerv Ment Dis. 2020 Feb;208(2):155-160. doi: 10.1097/NMD.0000000000001070.'}, {'pmid': '19388893', 'type': 'BACKGROUND', 'citation': 'Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants. Participants taking anxiolytics (n = 163) were randomly assigned to a single 24-minute session of sound-based treatment: combined (music \\& ABS), music-alone, ABS-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).', 'detailedDescription': "In this study, the investigators examined and compared the effectiveness of ABS in the theta range, calm music playlist curated by an affective music recommendation system, and the combination of ABS and the same music to reduce anxiety and stress levels (as measured by the State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)) compared to a control condition (pink noise). Prior work has demonstrated that ABS and music both reduce anxiety when presented on their own. It is hypothesized that music with ABS will lead to significantly lower anxiety levels and increased calmness compared to the other experimental conditions. Approximately 163 participants were recruited from the Prolific online participant pool (https://www.prolific.co). The experiment was conducted on the Qualtrics survey platform, and the experimental treatment was provided with the LUCID Research App. After reading and agreeing with the consent form, participants provided their Prolific ID and then filled out the Short Test of Music Preferences (STOMP), Queen's Music Questionnaire, Anxiety coping method's questionnaire, Positive and Negative Affect Scale (PANAS), Self-Assessment Manikin (SAM), Eysenck Personality Questionnaire, and the State Trait Inventory of Cognitive and Somatic Anxiety (STICSA). Participants were also asked to list any medications currently being taken (including cannabis). Participants were then randomly assigned to one of four treatment groups: (1) music; (2) music and auditory beat stimulation (ABS); (3) auditory beat stimulation (ABS) alone; or (4) pink noise for 24 minutes. Participants then received instructions on how to download the LUCID Research app on their iOS device or access the LUCID Research App through a virtual machine using their computer. Participants listened to their randomly assigned treatment for 24 minutes. Participants then completed their post-intervention questionnaires which included: the STICSA state version, SAM and PANAS. The investigators' hypotheses were that the combined, music alone and ABS alone conditions would experience a greater reduction in somatic and cognitive state anxiety compared to the pink noise control condition. These hypotheses were pre-registered using the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/VHCA5) and were based upon previous studies showing that ABS and music listening are capable of reducing anxiety. The investigators had no specific predictions for moderate and high trait anxiety participants, but their pre-registration noted their intention to recruit from both of these populations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18+)\n* Must be taking anxiety medication\n* Self-identified normal hearing\n* No known cardiac issues\n* No known epilepsy/seizures\n\n * Have access to an iOS device (iPhone or iPad) to run the Research Application\n\nExclusion Criteria:\n\n* Adults younger than 18\n* Not taking anxiety medication\n* Have known cardiac issues\n\n \\- Do not have access to an iOS device (iPhone or iPad) to run the Research Application\n* Have known epilepsy/seizures'}, 'identificationModule': {'nctId': 'NCT05171218', 'briefTitle': 'The Effects of Music & Auditory Beat Stimulation on Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'The Effects of Music & Auditory Beat Stimulation on Anxiety', 'orgStudyIdInfo': {'id': 'REB 2020-068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music & Auditory Beat Stimulation', 'description': 'Participants listened to calm music with theta auditory beat stimulation for 24 minutes', 'interventionNames': ['Behavioral: Music & Auditory Beat Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music Alone', 'description': 'Participants listened to calm music for 24 minutes', 'interventionNames': ['Behavioral: Music Alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auditory Beat Stimulation', 'description': 'Participants listened to theta auditory beat stimulation for 24 minutes', 'interventionNames': ['Behavioral: Auditory Beat Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Pink Noise', 'description': 'Participants listened to pink noise for 24 minutes', 'interventionNames': ['Behavioral: Pink Noise']}], 'interventions': [{'name': 'Music & Auditory Beat Stimulation', 'type': 'BEHAVIORAL', 'description': 'Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes', 'armGroupLabels': ['Music & Auditory Beat Stimulation']}, {'name': 'Music Alone', 'type': 'BEHAVIORAL', 'description': 'Listening to calm music Participants listened to calm music for 24 minutes', 'armGroupLabels': ['Music Alone']}, {'name': 'Auditory Beat Stimulation', 'type': 'BEHAVIORAL', 'description': 'Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes', 'armGroupLabels': ['Auditory Beat Stimulation']}, {'name': 'Pink Noise', 'type': 'BEHAVIORAL', 'description': 'Listening to pink noise Participants listened to pink noise for 24 minutes', 'armGroupLabels': ['Pink Noise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 2K3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ryerson University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Frank A Russo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Toronto Metropolitan University'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/efya2/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data are available now and will be for 7 years post data collection completion as per our REB approval: approximately January 2028', 'ipdSharing': 'YES', 'description': 'We have registered the project on Open Science Framework and will make all elements of IPD open to the public. Please see: https://osf.io/efya2/ Study protocol and analysis plan: https://doi.org/10.17605/ OSF.IO/VHCA5 Consent form: https://osf.io/efya2/', 'accessCriteria': 'There is no specific access criteria for the IPD on OSF. It is freely and openly available to anyone.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lucid, Inc.', 'class': 'INDUSTRY'}, {'name': 'Mitacs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Frank Russo', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}