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
About this trial
This is an interventional treatment trial for Anxiety State
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.
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
NCT ID
NCT05442099
First Posted
June 28, 2022
Last Updated
July 27, 2022
Sponsor
Toronto Metropolitan University
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
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
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
Results Reference
background
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
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.
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
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
34886210
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.
Results Reference
background
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
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
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
background
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The Effect of Iso-Principal Based Music Playlists on Anxiety
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