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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:
Participants will:
PHASE 1:
PHASE 2:
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:
PHASE 2:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Theme | Experimental | 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. |
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| Control Theme | Active Comparator | 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. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Theme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| 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. | Baseline |
| 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. | From baseline through study completion, an average of 90 minutes |
| 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. | Baseline |
| 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. |
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Phase 1:
Inclusion Criteria:
Exclusion Criteria:
- Over the age of 89
Phase 2:
Inclusion Criteria:
Exclusion Criteria:
- Over the age of 45
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lourdes P Dale, PhD | Contact | 9042448998 | Lourdes.Dale@jax.ufl.edu | |
| Audrey N Dana | Contact | audrey.dana@jax.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lourdes P Dale, PhD | University of Florida | Principal Investigator |
| John P Williamson, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida McKnight Brain Institution | Recruiting | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42338740 | Derived | 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. |
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IPD will not be available to protect the privacy of participants.
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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.
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Phase 2: Participants will be randomly assigned via a random number generator to either the augmented group or the control group. The participant will be blinded to the group they are assigned to.
| Mahler Theme | Behavioral | 15-minutes of a Mahler composition. |
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| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| UF Health Jacksonville | Completed | Jacksonville | Florida | 32209 | United States |