Listening to Calming Music

NCT06710886 | Recruiting

• 1 other identifier: IRB202401783
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Music; Autonomic State

Keywords

Polyvagal Theory; Adversity; Relaxation

Outcome Measures

Primary Outcomes (8)

• 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.

  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

Study Arms (2)

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.

Behavioral: Augmented Theme

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.

Behavioral: Mahler Theme

Interventions

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.

Augmented Theme

Mahler Theme BEHAVIORAL

15-minutes of a Mahler composition.

Control Theme

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Over the age of 89
• Phase 2:
• Between the ages of 18 and 45
• Proficient in English
• \- Over the age of 45

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

University of Florida McKnight Brain Institution

Gainesville, Florida, 32610, United States

RECRUITING

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

COMPLETED

Study Officials

• Lourdes P Dale, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• John P Williamson, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lourdes P Dale, PhD

CONTACT

9042448998; Lourdes.Dale@jax.ufl.edu

Audrey N Dana

CONTACT

audrey.dana@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): July 4, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)