30-Minutes of Listening to Calming Music on Attendees of a Workshop Session at a Local Conference

The Effect of Listening to 30-Minutes of Calming Music on Mental Health Professionals

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 music.
• To identify individual characteristics that influence the immediate effects of listening to the music.

Participants will:

• complete the online pre-assessment measures assessing their adversity history, psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
• Listen to the brief music demo
• Listen to the full 30-minute music session.
• Complete the online post-assessment measures assessing psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Anxiety; Autonomic Dysregulation
• Intervention / Treatment: Behavioral: Listening to Calming Music

Detailed Description

It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which listening to the music can influence emotional health, embodiment, and autonomic functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity.

Specific Aims:

Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity relate to the overall functioning of the participants.

•We 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 •We will explore whether listening to the music leads to improvements in the functioning. First, we will compare the participants who opted to leave after the brief music demonstration to the participants who stayed for the additional 30-minutes of music. Next, we 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

•We will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well mental health providers benefit from listening to the music immediately.

Experimental design

• Participation is limited to those attending the Global Exchange Conference
• 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 30-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 30-minutes of music to determine if those who listened to the 30-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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lake Buena Vista, Florida, United States, 32830
      • The Walt Disney World Dolphin Resort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Over the age of 89

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; Participants will be asked to listen to the brief music demo and the 30-minute music session. The pre- and post-assessments will require participants to complete a 5-10-minute online survey.	Behavioral: Listening to Calming Music; Participants will listen to calming music, which may enhance health and wellness by reducing autonomic reactivity and improving bodily awareness, brain-body connection, and emotional wellbeing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring Change in 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	From baseline through study completion, an average of 1 day
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 Body Sensations using the Neuroception of Psychological Safety Scale	This 8-item body sensations subscale is scored on a 5-point likert scale. Items are summed together to create a total subscale, with higher scores relecting internal sensations of the body in a state of calm capturing the feelings of relaxation in the face and the body, steady heartbeat and breath, and settled stomach.	From baseline through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Lourdes P Dale, PhD, UF College of Medicine Jacksonville, Department of Psychiatry

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Cabrera A, Kolacz J, Pailhez G, Bulbena-Cabre A, Bulbena A, Porges SW. Assessing body awareness and autonomic reactivity: Factor structure and psychometric properties of the Body Perception Questionnaire-Short Form (BPQ-SF). Int J Methods Psychiatr Res. 2018 Jun;27(2):e1596. doi: 10.1002/mpr.1596. Epub 2017 Nov 28.
• Dale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.
• Morton L, Cogan N, Kolacz J, Calderwood C, Nikolic M, Bacon T, Pathe E, Williams D, Porges SW. A new measure of feeling safe: Developing psychometric properties of the Neuroception of Psychological Safety Scale (NPSS). Psychol Trauma. 2024 May;16(4):701-708. doi: 10.1037/tra0001313. Epub 2022 Jul 18.
• Kroenke, K., & Spitzer, R. L. (2002). Patient Health Questionnaire-8 (PHQ-8)

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2024
• Primary Completion (Estimated): November 9, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Mental Health; Anxiety; Relaxation; Trauma; Music; Embodiment; Polyvagal Theory; Emotional Health; Adversity; Autonomic Reactivity; Social Connection; Body Sensations
• Additional Relevant MeSH Terms: Nervous System Diseases; Behavioral Symptoms; Depression; Autonomic Nervous System Diseases; Primary Dysautonomias
• Other Study ID Numbers: IRB202401167

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