The Effect of Iso-Principal Based Music Playlists on Anxiety

NCT ID: NCT05442099

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2022-08-15

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.

Conditions

Anxiety State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iso-principle music playlist

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

Group Type: EXPERIMENTAL

Iso-principle music playlist

Intervention Type: BEHAVIORAL

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

Generic calm music playlist

Participants listen to the generic music playlist for 30 minutes.

Group Type: SHAM_COMPARATOR

Generic calm music playlist

Intervention Type: BEHAVIORAL

Participants listen to the calm music playlist for 30 minutes.

Interventions

Iso-principle music playlist

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

Intervention Type: BEHAVIORAL

Generic calm music playlist

Participants listen to the calm music playlist for 30 minutes.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Toronto Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Frank Russo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Russo, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Adiel Mallik, PhD

Role: STUDY_DIRECTOR

Toronto Metropolitan University

Central Contacts

Adiel Mallik, PhD

Role: CONTACT

adiel.mallik@ryerson.ca

416-979-5000 ext. 4989

References

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.

Reference Type: BACKGROUND

PMID: 20954057 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18085930 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28325532 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35263341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25452734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16115248 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33418360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34886210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17309374 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3397865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31977827 (View on PubMed)

Other Identifiers

REB2020-068ISO2

Identifier Type: -

Identifier Source: org_study_id