The Effects of Music & Auditory Beat Stimulation on Anxiety

January 5, 2022 updated by: Frank Russo, Ryerson University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music & Auditory Beat Stimulation
Participants listened to calm music with theta auditory beat stimulation for 24 minutes
Behavioral: Music & Auditory Beat Stimulation
Listening to calm music and auditory beat stimulation Participants listened to calm music with theta auditory beat stimulation for 24 minutes
Active Comparator: Music Alone
Participants listened to calm music for 24 minutes
Behavioral: Music Alone
Listening to calm music Participants listened to calm music for 24 minutes
Active Comparator: Auditory Beat Stimulation
Participants listened to theta auditory beat stimulation for 24 minutes
Behavioral: Auditory Beat Stimulation
Listening to theta auditory beat stimulation Participants listened to theta auditory beat stimulation for 24 minutes
Sham Comparator: Pink Noise
Participants listened to pink noise for 24 minutes
Behavioral: Pink Noise
Listening to pink noise Participants listened to pink noise for 24 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time Frame: 24 minutes
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.
24 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood: Positive and Negative Affect Scale (PANAS)
Time Frame: 24 minutes
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.
24 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Collaborators

Mitacs
Lucid, Inc.

Investigators

  • Study Director: Frank A Russo, PhD, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

November 27, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 2020-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Individual Participant Data Set
  2. Study Protocol
  3. Statistical Analysis Plan
  4. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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