Clinical trial NCT06710886: Listening to Calming Music
Official title: The Effect of Listening to Calming Music
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Music
Autonomic State
Keywords: Polyvagal Theory
Adversity
Relaxation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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 the Mozart 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 Mozart composition.

  * Augmented music group: 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.
  * Control group: The selected Mozart composition consists of: Composition Eine kleine Nachtmusik, K. 525 (5 minutes 30 seconds), Andante from Piano Concerto No. 21, K. 467 (6 minutes 30 seconds), and Ave verum corpus, K. 618 (3 minutes). This composition is structured to serve as emotionally immersive, musically coherent control conditions in a 15-minute experimental paradigm.
* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
timeFrame: Baseline
measure: Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
timeFrame: Baseline
measure: Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
timeFrame: From baseline through study completion, an average of 90 minutes
measure: Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7
timeFrame: Baseline
measure: Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8
timeFrame: Baseline
measure: Assessing the Impact of loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness
timeFrame: Baseline
measure: Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley
timeFrame: Baseline
measure: Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida McKnight Brain Institution
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Lourdes P Dale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: John P Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References: