Calming Music for Autonomic Dysfunction

Overseen By Audrey N Dana

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Over 89, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how calming music might benefit individuals with autonomic dysfunction, a condition affecting automatic bodily functions like heart rate and digestion. Participants will listen to either specially augmented music or a Mozart composition to assess potential improvements in health and well-being. The trial includes completing surveys and monitoring heart rate to evaluate the music's immediate effects. It suits English speakers aged 18 to 45 who attend online workshops, especially those experiencing symptoms related to autonomic dysfunction. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance well-being through music.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on listening to music.

What prior data suggests that listening to calming music is safe for participants?

A previous study showed that listening to calming music affects the part of the nervous system that controls heart rate and digestion. Research shows that music therapy can also help reduce anxiety. It has been safely used alongside other treatments for conditions like anxiety disorders and ADHD. Studies have not reported major side effects, indicating it is generally well-tolerated. This suggests that listening to calming music is a safe option for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using calming music for autonomic dysfunction because it offers a non-invasive and side-effect-free alternative to traditional medical treatments like medications or physical therapy. This approach harnesses the power of music to potentially regulate the autonomic nervous system, which controls functions like heart rate and digestion, in a natural way. The trial is testing two types of music: an augmented music experience and a classical Mozart composition, to see which might be more effective in promoting relaxation and autonomic balance. This innovative method could provide a simple and enjoyable way to support patients with autonomic dysfunction, making it a promising area of research.

What evidence suggests that listening to calming music might be an effective treatment for autonomic dysfunction?

Studies have shown that calming music can positively affect the part of the nervous system that controls heart rate and digestion. Research indicates that listening to music might help reduce stress and anxiety by influencing these automatic body functions. In this trial, participants will experience different music interventions. One group will listen to augmented music, while another will listen to a Mozart composition. For example, one study found that music therapy could lower heart rates and decrease feelings of stress. Another study suggested that music could help manage symptoms in people with brain disorders, which sometimes affect these automatic functions. Overall, early findings suggest that music can have a calming effect on the body and mind, potentially improving overall wellness. ^{6 7 8 9 10}

Who Is on the Research Team?

Lourdes P Dale, PhD

Principal Investigator

University of Florida

John P Williamson, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 89 who are proficient in English and attending an online workshop session. It's designed for those experiencing dysautonomia or autonomic dysfunction, aiming to assess if calming music can improve their condition.

Inclusion Criteria

I am proficient in English.

I attended an online workshop session.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants complete online pre- and post-surveys, listen to a brief music demo, and then a full 15-minute music session.

1 day

1 visit (virtual)

Phase 2

Participants complete online pre- and post-surveys, provide saliva samples, and listen to a 15-minute music session with heart rate monitoring.

1 day

1 visit (virtual)

Follow-up

Participants are monitored for changes in subjective feelings of calmness and autonomic state after the music intervention.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Listening to Calming Music

Trial Overview

The study tests the immediate effects of listening to calming music on participants with autonomic disorders. It involves pre- and post-assessment measures related to stress, psychiatric symptoms, body awareness, and social connection after a music session.

How Is the Trial Designed?

Group I: Augmented Theme Experimental Treatment 1 Intervention

In phase 1: Participants complete the pre-survey. After that, the participants will listen to a brief demo followed by the 15-minutes of augmented music. After completion of the music, the participants will complete the post-survey. In phase 2: Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants in the augmented group will receive 15-minutes of augmented music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.

Group II: Mozart Theme Active Control 1 Intervention

In phase 2: Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants will receive 15-minutes of the control music featuring a Mozart composition. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

A meeting of sedation experts identified significant gaps in the measurement of safety during procedural sedation research, highlighting that only 6 out of 133 reviewed studies used validated safety measures.

The experts recommended a set of core and supplemental safety measures to improve consistency in reporting adverse events, which will enhance the quality of safety data in future clinical trials and aid in systematic reviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. Ward, DS., Williams, MR., Berkenbosch, JW., et al.[2019]

A comprehensive database of 396,985 drug-related cardiac adverse effects (AEs) linked to 1,632 approved drugs was created, revealing significant clusters of AEs affecting heart function, such as arrhythmias and heart failure.

The study identified that cardiac AEs are highly correlated with drugs targeting cardiovascular functions and specific mechanisms of action, including interactions with various receptors like alpha- and beta-adrenergic receptors, which may help predict and understand these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. Matthews, EJ., Frid, AA.[2013]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

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