Listening to Calming Music

March 6, 2026 updated by: University of Florida

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida McKnight Brain Institution
        • Contact:
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Completed
        • UF Health Jacksonville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Phase 1:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Theme

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.
Behavioral: Augmented Theme
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.
Active Comparator: Control Theme

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.
Behavioral: Mahler Theme
15-minutes of a Mahler composition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
Time Frame: 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.
Baseline
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
Time Frame: 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
Baseline
Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
Time Frame: 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.
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
Time Frame: 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.
Baseline
Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8
Time Frame: 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.
Baseline
Assessing the Impact of loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness
Time Frame: 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.
Baseline
Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley
Time Frame: 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.
Baseline
Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Lourdes P Dale, PhD, University of Florida
  • Principal Investigator: John P Williamson, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

July 4, 2026

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202401783

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be available to protect the privacy of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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