The Effects of Music & Auditory Beat Stimulation on Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music & Auditory Beat Stimulation
Music Alone
Auditory Beat Stimulation
Pink Noise
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Auditory Beat Stimulation, Binaural Beats, Mental Health, Music, Neuroscience, Psychology
Eligibility Criteria
Inclusion Criteria:
- Adults (18+)
- Must be taking anxiety medication
- Self-identified normal hearing
- No known cardiac issues
No known epilepsy/seizures
- Have access to an iOS device (iPhone or iPad) to run the Research Application
Exclusion Criteria:
- Adults younger than 18
- Not taking anxiety medication
Have known cardiac issues
- Do not have access to an iOS device (iPhone or iPad) to run the Research Application
- Have known epilepsy/seizures
Sites / Locations
- Ryerson University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Music & Auditory Beat Stimulation
Music Alone
Auditory Beat Stimulation
Pink Noise
Arm Description
Participants listened to calm music with theta auditory beat stimulation for 24 minutes
Participants listened to calm music for 24 minutes
Participants listened to theta auditory beat stimulation for 24 minutes
Participants listened to pink noise for 24 minutes
Outcomes
Primary Outcome Measures
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
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.
Secondary Outcome Measures
Mood: Positive and Negative Affect Scale (PANAS)
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.
Full Information
NCT ID
NCT05171218
First Posted
November 27, 2021
Last Updated
January 5, 2022
Sponsor
Toronto Metropolitan University
Collaborators
Lucid, Inc., Mitacs
1. Study Identification
Unique Protocol Identification Number
NCT05171218
Brief Title
The Effects of Music & Auditory Beat Stimulation on Anxiety
Official Title
The Effects of Music & Auditory Beat Stimulation on Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Lucid, Inc., Mitacs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Auditory Beat Stimulation, Binaural Beats, Mental Health, Music, Neuroscience, Psychology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music & Auditory Beat Stimulation
Arm Type
Experimental
Arm Description
Participants listened to calm music with theta auditory beat stimulation for 24 minutes
Arm Title
Music Alone
Arm Type
Active Comparator
Arm Description
Participants listened to calm music for 24 minutes
Arm Title
Auditory Beat Stimulation
Arm Type
Active Comparator
Arm Description
Participants listened to theta auditory beat stimulation for 24 minutes
Arm Title
Pink Noise
Arm Type
Sham Comparator
Arm Description
Participants listened to pink noise for 24 minutes
Intervention Type
Behavioral
Intervention Name(s)
Music & Auditory Beat Stimulation
Intervention Description
Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes
Intervention Type
Behavioral
Intervention Name(s)
Music Alone
Intervention Description
Listening to calm music Participants listened to calm music for 24 minutes
Intervention Type
Behavioral
Intervention Name(s)
Auditory Beat Stimulation
Intervention Description
Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes
Intervention Type
Behavioral
Intervention Name(s)
Pink Noise
Intervention Description
Listening to pink noise Participants listened to pink noise for 24 minutes
Primary Outcome Measure Information:
Title
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
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.
Time Frame
24 minutes
Secondary Outcome Measure Information:
Title
Mood: Positive and Negative Affect Scale (PANAS)
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.
Time Frame
24 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (18+)
Must be taking anxiety medication
Self-identified normal hearing
No known cardiac issues
No known epilepsy/seizures
Have access to an iOS device (iPhone or iPad) to run the Research Application
Exclusion Criteria:
Adults younger than 18
Not taking anxiety medication
Have known cardiac issues
- Do not have access to an iOS device (iPhone or iPad) to run the Research Application
Have known epilepsy/seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A Russo, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Study Director
Facility Information:
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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/
IPD Sharing Time Frame
Data are available now and will be for 7 years post data collection completion as per our REB approval: approximately January 2028
IPD Sharing Access Criteria
There is no specific access criteria for the IPD on OSF. It is freely and openly available to anyone.
IPD Sharing URL
https://osf.io/efya2/
Citations:
PubMed Identifier
20954057
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.
Results Reference
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.
Results Reference
background
PubMed Identifier
18085930
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.
Results Reference
background
PubMed Identifier
33418360
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.
Results Reference
background
PubMed Identifier
3397865
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.
Results Reference
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.
Results Reference
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PubMed Identifier
28325532
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.
Results Reference
background
PubMed Identifier
25452734
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.
Results Reference
background
PubMed Identifier
16115248
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.
Results Reference
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PubMed Identifier
17309374
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.
Results Reference
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PubMed Identifier
31977827
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.
Results Reference
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PubMed Identifier
19388893
Citation
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Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://osf.io/efya2/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.17605/OSF.IO/VHCA5
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://doi.org/10.17605/OSF.IO/VHCA5
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://osf.io/efya2/
Learn more about this trial
The Effects of Music & Auditory Beat Stimulation on Anxiety
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