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The Effect of Iso-Principal Based Music Playlists on Anxiety

Primary Purpose

Anxiety State

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iso-principle music playlist
Generic calm music playlist
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety State

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants who have no hearing impairments
  • Participants who have no cardiac issues.
  • Participants who have no history of seizures and epilepsy.

Exclusion Criteria:

  • Participants who have hearing impairments
  • Participants who have cardiac issues.
  • Participants who have a history of seizures and epilepsy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Iso-principle music playlist

    Generic calm music playlist

    Arm Description

    Participants listen to the iso-principle music playlist for 30 minutes.

    Participants listen to the generic music playlist for 30 minutes.

    Outcomes

    Primary Outcome Measures

    Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
    The STICSA has good reliability and validity as a measure of state and trait cognitive and somatic anxiety (Bados et al. 2010, Gros et al. 2007). 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 PANAS has good reliability and validity and has been widely used in many studies to assess mood (Gray, 2007; Watson, Clark, & Tellegen, 1988). 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

    First Posted
    June 28, 2022
    Last Updated
    July 27, 2022
    Sponsor
    Toronto Metropolitan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05442099
    Brief Title
    The Effect of Iso-Principal Based Music Playlists on Anxiety
    Official Title
    The Effect of Iso-Principal Based Music Playlists on Anxiety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2022 (Anticipated)
    Primary Completion Date
    August 15, 2022 (Anticipated)
    Study Completion Date
    August 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Toronto Metropolitan University

    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
    Chronic anxiety is a growing psychological challenge worldwide and at pre-clinical levels, can be disabling. Some research suggests music may reduce anxiety symptoms as effectively as anti-anxiety drugs without the adverse side effects. The iso principle suggests that the effectiveness of music interventions for mood management can be maximized by commencing a session with music that matches an individual's current emotional state and then gradually moving toward their desired emotional state. Our previous work demonstrated that a playlist generated by a music recommendation system that uses the iso-principal, along with music informatics, auditory beat stimulation, and reinforcement learning can reduce somatic and cognitive anxiety. However, it is unknown whether music playlists based on the iso-principal alone can reduce anxiety. In this study, the investigators wish to examine whether music playlists (~30 min long) based on the iso-principal (neutral to calm) will reduce anxiety after anxiety induction compared to a calm music playlist. The investigators hypothesize that the iso-principal playlist will have greater state anxiety reduction compared to the calm playlist.
    Detailed Description
    Chronic anxiety is a growing psychological challenge worldwide and at pre-clinical levels, can be disabling. Some research suggests music may reduce anxiety symptoms as effectively as anti-anxiety drugs without the adverse side effects. The iso principle suggests that the effectiveness of music interventions for mood management can be maximized by commencing a session with music that matches an individual's current emotional state and then gradually moving toward their desired emotional state. Our previous work demonstrated that a playlist generated by a music recommendation system that uses the iso-principal, along with music informatics, auditory beat stimulation, and reinforcement learning can reduce somatic and cognitive anxiety. However, it is unknown whether music playlists based on the iso-principal alone can reduce anxiety. In this study, the investigators wish to examine whether music playlists (~30 min long) based on the iso-principal (neutral to calm) will reduce anxiety after anxiety induction compared to a calm music playlist. The investigators hypothesize that the iso-principal playlist will have greater state anxiety reduction compared to the reverse-iso and calm playlists. Participants (n = 100) will be recruited and randomly assigned to one of three groups 1) Iso principal playlist, 2) Calm playlist. Prior to their treatment, all participants will undergo anxiety induction (recall an anxiety-provoking event, while listening to anxiety-inducing music). State anxiety (STICSA), positive and negative affect (PANAS), arousal, and valence (SAM) will be measured pre-post anxiety induction and after treatment. This work will be the first of its kind to examine whether a playlist based on the iso-principal is effective at reducing anxiety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety State

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Iso-principle music playlist
    Arm Type
    Experimental
    Arm Description
    Participants listen to the iso-principle music playlist for 30 minutes.
    Arm Title
    Generic calm music playlist
    Arm Type
    Sham Comparator
    Arm Description
    Participants listen to the generic music playlist for 30 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Iso-principle music playlist
    Intervention Description
    Participants listen to the iso-principle music playlist for 30 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Generic calm music playlist
    Intervention Description
    Participants listen to the calm music playlist for 30 minutes.
    Primary Outcome Measure Information:
    Title
    Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
    Description
    The STICSA has good reliability and validity as a measure of state and trait cognitive and somatic anxiety (Bados et al. 2010, Gros et al. 2007). 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
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Mood: Positive and Negative Affect Scale (PANAS)
    Description
    The PANAS has good reliability and validity and has been widely used in many studies to assess mood (Gray, 2007; Watson, Clark, & Tellegen, 1988). 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
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants who have no hearing impairments Participants who have no cardiac issues. Participants who have no history of seizures and epilepsy. Exclusion Criteria: Participants who have hearing impairments Participants who have cardiac issues. Participants who have a history of seizures and epilepsy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adiel Mallik, PhD
    Phone
    416-979-5000
    Ext
    4989
    Email
    adiel.mallik@ryerson.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Russo, PhD
    Organizational Affiliation
    Toronto Metropolitan University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Adiel Mallik, PhD
    Organizational Affiliation
    Toronto Metropolitan University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual de-identified participant data for STICSA state anxiety, PANAS, and SAM measures will be shared on the Open Science Framework.
    IPD Sharing Time Frame
    Data will become available on the Open Science Framework (osf.io) when the pre-print of the study is uploaded to PsyArXiv. After that point the data will be available for a period of 5 years.
    IPD Sharing Access Criteria
    All supporting information will be publicly accessible on the Open Science Framework (osf.io).
    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
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    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
    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
    Citation
    Heiderscheit, A., & Madson, A. (2015). Use of the Iso Principle as a Central Method in Mood Management: A Music Psychotherapy Clinical Case Study. Music Therapy Perspectives, 33(1), 45-52. doi:10.1093/mtp/miu042 %J Music Therapy Perspectives
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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.
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    PubMed Identifier
    35263341
    Citation
    Mallik A, Russo FA. The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. PLoS One. 2022 Mar 9;17(3):e0259312. doi: 10.1371/journal.pone.0259312. eCollection 2022.
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    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.
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    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.
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    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.
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    PubMed Identifier
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    Citation
    Starcke K, Mayr J, von Georgi R. Emotion Modulation through Music after Sadness Induction-The Iso Principle in a Controlled Experimental Study. Int J Environ Res Public Health. 2021 Nov 26;18(23):12486. doi: 10.3390/ijerph182312486.
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