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MusicNCT06710886

Listening to Calming Music

A study testing Augmented Theme and Mahler Theme in people with Music and Autonomic State, run by University of Florida at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are: To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Music, Autonomic State
What is being tested?
Augmented Theme and Mahler Theme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
4 Dec 2024to 25 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Between the ages of 18 and 89
  • Proficient in English
  • Attendees of an online workshop session
  • Between the ages of 18 and 45
  • Proficient in English

Who cannot join

  • Over the age of 89
  • Phase 2:
  • Over the age of 45

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lourdes P Dale, PhD contact

9042448998

Lourdes.Dale@jax.ufl.edu

Audrey N Dana contact

audrey.dana@jax.ufl.edu

United States2 sites, 1 recruiting
  • University of Florida McKnight Brain Institution

    Gainesville, Florida, 32610

    John Williamson, PhD, 352-294-4903, john.williamson@ufl.edu

    Carrie Lee, BS, (352) 294-4903, carrie.lee@ufl.edu

    Recruiting
  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Completed

Other trials in United States

About this study

Official title: The Effect of Listening to Calming Music

The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are:

  • To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
  • To examine the immediate effects of listening to the augmented music.
  • To identify individual characteristics that influence the immediate effects of listening to the augmented music.
Read more

Participants will:

PHASE 1:

  • Complete the online pre- and post-surveys
  • Listen to the brief music demo
  • Listen to the full 15-minutes music session

PHASE 2:

  • Complete the online pre- and post-surveys.
  • Heart rate data will be collected continuously for about 25 minutes. It will be collected for 5 minutes before and after the intervention, and for 15 minutes during the intervention.
  • Provide pre- and post- music saliva samples (1.5mL).
  • Listen to full 15-minutes music session.
Read the detailed description

The purpose of the current study is to explore the effects of listening to 15-minutes of sonic augmented music on subjective feelings of calmness and autonomic state.

Specific Aims:

Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity relate to the overall functioning of the participants.

•The investigators will examine measures of autonomic reactivity to prior mental health and medical adversity, embodiment, and emotional and physical health.

Specific Aim 2: To identify the immediate effects of listening to the music

•The investigators will explore whether listening to the music leads to improvements in the functioning. First, the investigators will compare the participants who opted to leave after the brief music demonstration to the participants who stayed for the additional 15-minutes of music. Next, the investigators will focus on improvements following listening to the music.

Specific Aim 3: To identify individual characteristics that influence the effectiveness of listening to the music immediately

•The investigators will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well participants benefit from listening to the music immediately.

Specific Aim 4: To investigate levels of oxytocin and HRV after listening to calming music.

•The investigators will explore whether listening to music leads to changes in physiological and emotional responses, focusing on oxytocin as a marker of stress response. Specifically, we will compare the levels of salivary oxytocin before and after the intervention in two groups: participants who listen to 15 minutes of the control theme and participants who listen to 15 minutes of the augmented theme. We will also measure heart rate (HR) using a wearable HR monitor to assess autonomic nervous system functioning and determine whether changes in HR are associated with changes in oxytocin levels following the music intervention. (Phase 2 only)

Experimental design

PHASE 1:

  • Participation is limited to those attending the online workshop
  • The participants will complete pre- and post-assessments that involve online measures.
  • Music will be provided first in a brief music demo and then again in a 15-minute session.
  • Between-subject analyses will compare those who listened only to the brief demo and withdrew participation against those who remained and listened to the 15-minutes of music to determine if those who listened to the 15-minutes of music exhibit greater improvements than those who did not. Within-subject analyses will determine the potential benefits of listening to the music for all participants.

PHASE 2:

  • The participants will be randomly assigned to either the augmented music group or the control group featuring a Mahler composition.
  • The control group will listen to 15 minutes of control music, and the augmented group will listen to 15 minutes of augmented music.
  • At pre- and post-, the participants will complete online self-report surveys and provide 1.5mL of saliva.
  • Heart rate data will be collected continuously for about 25 minutes. It will be collected for 5 minutes before and after the intervention, and for 15 minutes during the intervention. Markers will inserted to later separate the data into segments representing the 5 minutes before the music (baseline), time during the music, and 5 minutes after the administration of the music.
  • Between-subject analyses will compare those who listened only to the augmented 15-minute music sample and those who listened to the control 15-minutes of music to determine if those who listened to the augmented music exhibit greater changes than those who did not. Subject analyses will determine the potential benefits of listening to music for all participants.
Being tested
Augmented Theme, Mahler Theme
Keywords
Polyvagal Theory, Adversity, Relaxation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented ThemeBehavioural

    The music is augmented by embedding the natural rhythms of bodily functions (e.g. breathing, heart rate variability, vascular tone, etc) that signal the body to calm.

  • Mahler ThemeBehavioural

    15-minutes of a Mahler composition.

Study groups in NCT06710886
Study groupRoleWhat they receive
Augmented ThemeExperimentalIn 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.
Receives: Behavioral: Augmented Theme
Control ThemeActive comparatorIn 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. 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.
Receives: Behavioral: Mahler Theme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form

    This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity

    Measured: Baseline

  2. Assessing the Impact of Adversity History on the Effectiveness of Listening to Music

    This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.

    Measured: Baseline

  3. Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List

    This 20-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.

    Measured: From baseline through study completion, an average of 90 minutes

  4. Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7

    This 7-item measure assesses the severity of generalized anxiety symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to calculate the total anxiety score, with higher scores indicating more severe anxiety symptoms.

    Measured: Baseline

  5. Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8

    This 8-item measure assesses the severity of depressive symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to determine the total depression score, with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline

  6. Assessing the Impact of loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness

    This 20-item measure assesses how often a person feels disconnected from others. It is scored on a 4-point Likert scale (never = 1, rarely = 2, sometimes = 3, often = 4). The items are summed to calculate the total loneliness score, with higher scores indicating greater feelings of loneliness.

    Measured: Baseline

  7. Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley

    This 60-item measure assesses the level of hostility and negative affectivity. It is scored on a true/false format, where responses are recorded as 1 for "true" and 0 for "false." The items are summed to determine the total hostility score, with higher scores indicating greater levels of hostility.

    Measured: Baseline

  8. Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3

    The QRISK3 is a risk assessment tool used to estimate the 10-year risk of developing cardiovascular disease. It is based on a variety of factors, including age, sex, blood pressure, cholesterol levels, smoking status, and medical history. The score is calculated using a point-based system, with higher scores indicating a higher risk of cardiovascular events. The result provides an estimated percentage of risk over the next 10 years.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start4 Dec 2024
  3. Primary completion4 Jul 2026 (estimated)
  4. Study completion25 Dec 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
In Phase 1: The participants will listen to the brief music demo together after completing the pre-assessment. After the demo is completed, participants will listen to the 15-minutes of music. For those who opt out of listening to the 15-minutes of music, they will be asked to complete the post-assessment. Following the 15-minute music session, the remaining participants will be asked to complete the post-assessment. In Phase 2: Participants will be randomly assigned to the augmented or control music group. Both groups will complete a pre-survey and provide a saliva sample. Then, they will be equipped with a HR band (polar exercise band) and baseline HR will be established within 5 minutes. Following the 15-minutes of music, participants will provide 5 minutes of HR information post-intervention, provide a saliva sample, and complete a post-survey.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710886
Sponsor's protocol ID
IRB202401783
Status last verified
Jun 2025
First submitted
26 Nov 2024
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be available to protect the privacy of participants.

Publications

  • Dale LP, Dana AN, Lee CE, Lamont H, Van Vleet Goelz D, Dale CV, Nazarloo P, McIntosh M, Cuffe SP. Feasibility study examining the short-term effects of Sonic Augmentation Technology. Front Psychiatry. 2026 Jun 8;17:1772405. doi: 10.3389/fpsyt.2026.1772405. eCollection 2026.

    PubMed 42338740

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Theme and Mahler Theme in people with Music and Autonomic State, run by University of Florida at 2 sites in United States.

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 5 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lourdes P Dale, PhD (9042448998, Lourdes.Dale@jax.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form (time frame: Baseline). The study lists 8 primary outcomes in all. 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 NCT06710886, which also lists 1 linked publication.

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 10 Mar 2026.

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