Recruiting

Calming Music

Sponsor:

University of Florida

Code:

NCT06710886

Conditions

Music

Autonomic State

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Augmented Theme

Mahler Theme

Study Details

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

Study ID

NCT06710886

Start date

Dec 4, 2024

Status verified date

Jun, 2025

Completion date

Dec 25, 2026

Anticipated

Primary completion date

Jul 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Mahler Theme

15-minutes of a Mahler composition.

Primary outcome measure

  • Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form [ Time Frame: Baseline ]
  • Assessing the Impact of Adversity History on the Effectiveness of Listening to Music [ Time Frame: 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 ]
  • Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7 [ Time Frame: Baseline ]
  • Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8 [ Time Frame: Baseline ]
  • Assessing the Impact of loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness [ Time Frame: Baseline ]
  • Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley [ Time Frame: Baseline ]
  • Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3 [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Lourdes P Dale, PhD

9042448998Lourdes.Dale@jax.ufl.edu

Audrey N Dana

audrey.dana@jax.ufl.edu

Locations

University of Florida McKnight Brain Institution

Recruiting

Gainesville, Florida, United States, 32610

Contacts

John Williamson, PhD

352-294-4903john.williamson@ufl.edu

Carrie Lee, BS

(352) 294-4903carrie.lee@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Mar 10, 2026

Last verified

Jun, 2025

Keywords

  • Polyvagal Theory
  • Adversity
  • Relaxation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-10.