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

NCT ID: NCT06557759

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Anxiety Autonomic Dysregulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 30-minutes of music. For those who opt out of listening to the 30-minutes of music, they will be asked to complete the post-assessment as they exit. Following the 30-minute music session, the remaining participants will be asked to complete the post-assessment.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Listening to Calming Music

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lourdes P Dale, PhD

Role: PRINCIPAL_INVESTIGATOR

UF College of Medicine Jacksonville, Department of Psychiatry

References

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Dale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29193423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35849369 (View on PubMed)

Kroenke, K., & Spitzer, R. L. (2002). Patient Health Questionnaire-8 (PHQ-8)

Reference Type BACKGROUND

Other Identifiers

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IRB202401167

Identifier Type: -

Identifier Source: org_study_id