Listening to Calming Music

Not Applicable

Recruiting

• Conditions: Music; Autonomic State

• Registration Number: NCT06710886
• Lead Sponsor: University of Florida

Brief 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.

* 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.

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.

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 unaugmented music and participants who listen to 15 minutes of augmented music. 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 non-augmented musical group.

* Augmented music group (interventional): 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.

* Non-augmented music group (control): Same melodic theme without the augmentation.

* The non-augmented group will listen to 15 minutes of unaugmented 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 unaugmented 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.

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Study Start: 2024-12-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-07-04
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Over the age of 89

Phase 2:

Inclusion Criteria:

• Between the ages of 18 and 45
• Proficient in English

Exclusion Criteria:

• Over the age of 45

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form	Baseline	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
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music	Baseline	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.
Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List	From baseline through study completion, an average of 90 minutes	This 20-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.
Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7	Baseline	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.
Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8	Baseline	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.
Assessing the Impact of loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness	Baseline	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.
Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley	Baseline	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.
Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3	Baseline	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.

Trial Locations

Locations (2)

University of Florida McKnight Brain Institution; 🇺🇸 Gainesville, Florida, United States

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States