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AzTrials

AnxietyNCT05171218

The Effects of Music & Auditory Beat Stimulation on Anxiety

A study testing Music & Auditory Beat Stimulation, Music Alone and Auditory Beat Stimulation in people with Anxiety, run by Toronto Metropolitan University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety
What is being tested?
Music & Auditory Beat Stimulation, Music Alone and Auditory Beat Stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
1 siteCanada
Study dates
9 Jul 2020to 2 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ryerson University

    Toronto, Ontario, M5B 2K3

Other trials in Canada

About this study

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).

Read the 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.

Conditions
Anxiety
Being tested
Music & Auditory Beat Stimulation, Music Alone, Auditory Beat Stimulation, Pink Noise
Keywords
Anxiety, Auditory Beat Stimulation, Binaural Beats, Mental Health, Music, Neuroscience, Psychology
Medical subject headings
Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music & Auditory Beat StimulationBehavioural

    Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes

  • Music AloneBehavioural

    Listening to calm music Participants listened to calm music for 24 minutes

  • Auditory Beat StimulationBehavioural

    Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes

  • Pink NoiseBehavioural

    Listening to pink noise Participants listened to pink noise for 24 minutes

Study groups in NCT05171218
Study groupRoleWhat they receive
Music & Auditory Beat StimulationExperimentalParticipants listened to calm music with theta auditory beat stimulation for 24 minutes
Receives: Behavioral: Music & Auditory Beat Stimulation
Music AloneActive comparatorParticipants listened to calm music for 24 minutes
Receives: Behavioral: Music Alone
Auditory Beat StimulationActive comparatorParticipants listened to theta auditory beat stimulation for 24 minutes
Receives: Behavioral: Auditory Beat Stimulation
Pink NoiseSham comparatorParticipants listened to pink noise for 24 minutes
Receives: Behavioral: Pink Noise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 minutes

Secondary outcomes (1)

  1. 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.

    Measured: 24 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2021
  2. Study start9 Jul 2020
  3. Primary completion2 Feb 2021
  4. Study completion2 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171218
Sponsor's protocol ID
REB 2020-068
Status last verified
Jan 2022
First submitted
27 Nov 2021
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 20954057

  • 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.

  • 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.

    PubMed 18085930

  • 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.

    PubMed 33418360

  • 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.

    PubMed 3397865

  • 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.

  • 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.

    PubMed 28325532

  • 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.

    PubMed 25452734

  • 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.

    PubMed 16115248

  • 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.

    PubMed 17309374

  • 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.

    PubMed 31977827

  • 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.

    PubMed 19388893

Questions about this trial

What is this clinical trial studying?

A study testing Music & Auditory Beat Stimulation, Music Alone and Auditory Beat Stimulation in people with Anxiety, run by Toronto Metropolitan University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) (time frame: 24 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05171218, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.

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