Anxiety StateNCT05442099
The Effect of Iso-Principal Based Music Playlists on Anxiety
A study testing Iso-principle music playlist and Generic calm music playlist in people with Anxiety State, run by Toronto Metropolitan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- What is being tested?
- Iso-principle music playlist and Generic calm music playlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 15 Aug 2022
- 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 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have no hearing impairments
- Participants who have no cardiac issues.
- Participants who have no history of seizures and epilepsy.
Who cannot join
- Participants who have hearing impairments
- Participants who have cardiac issues.
- Participants who have a history of seizures and epilepsy.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Iso-principle music playlist, Generic calm music playlist
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iso-principle music playlistBehavioural
Participants listen to the iso-principle music playlist for 30 minutes.
Generic calm music playlistBehavioural
Participants listen to the calm music playlist for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Iso-principle music playlist | Experimental | Participants listen to the iso-principle music playlist for 30 minutes. Receives: Behavioral: Iso-principle music playlist |
| Generic calm music playlist | Sham comparator | Participants listen to the generic music playlist for 30 minutes. Receives: Behavioral: Generic calm music playlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Russo, Toronto Metropolitan University
- Investigators
- Frank Russo, PhD, Principal investigator, Toronto Metropolitan UniversityAdiel Mallik, PhD, Study director, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442099
- Sponsor's protocol ID
- REB2020-068ISO2
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data for STICSA state anxiety, PANAS, and SAM measures will be shared on the Open Science Framework.
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 20954057Davis 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.
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 18085930Heiderscheit, 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
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 28325532Mallik 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.
PubMed 35263341McConnell 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 25452734Padmanabhan 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 16115248Phillips 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 33418360Starcke 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.
PubMed 34886210Wahbeh 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 17309374Watson 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 3397865Yusim 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iso-Principal Based Music Playlists on Anxiety
- ClinicalTrials.gov ID
- NCT05442099
- Acronym / sponsor ID
- REB2020-068ISO2
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iso-principle music playlist | Experimental | Behavioral: Iso-principle music playlistParticipants listen to the iso-principle music playlist for 30 minutes. |
| Generic calm music playlist | Sham comparator | Behavioral: Generic calm music playlistParticipants listen to the generic music playlist for 30 minutes. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who have no hearing impairments
- Participants who have no cardiac issues.
- Participants who have no history of seizures and epilepsy.
Key exclusion criteria (3 listed)
- Participants who have hearing impairments
- Participants who have cardiac issues.
- Participants who have a history of seizures and epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iso-principle music playlistParticipants listen to the iso-principle music playlist for 30 minutes. | Behavioural | Iso-principle music playlist |
| Generic calm music playlistParticipants listen to the calm music playlist for 30 minutes. | Behavioural | Generic calm music playlist |
Primary outcome
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time frame: 30 minutes
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.
1 secondary outcome
Mood: Positive and Negative Affect Scale (PANAS)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 20954057Bados 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.
- BackgroundDavis 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.
- BackgroundGray 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.
- Background: PubMed 18085930Gros 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.
- BackgroundHeiderscheit, 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
- Background: PubMed 28325532Isik 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.
- Background: PubMed 35263341Mallik 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.
- Background: PubMed 25452734McConnell 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.
- Background: PubMed 16115248Padmanabhan 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.
- Background: PubMed 33418360Phillips 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.
- Background: PubMed 34886210Starcke 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.
- Background: PubMed 17309374Wahbeh 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.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data for STICSA state anxiety, PANAS, and SAM measures will be shared on the Open Science Framework.
Related trials for Anxiety State
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Russo, PhD principal investigator
Toronto Metropolitan University
Adiel Mallik, PhD study director
Toronto Metropolitan University
Questions about this trial
What is this clinical trial studying?
A study testing Iso-principle music playlist and Generic calm music playlist in people with Anxiety State, run by Toronto Metropolitan University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adiel Mallik, PhD (416-979-5000 ext. 4989, adiel.mallik@ryerson.ca), or a site near the patient. 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: 30 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 NCT05442099, which also lists 14 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 28 Jul 2022.