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

NCT06557759 | Withdrawn

• 1 other identifier: IRB202401167
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Depression; Anxiety; Autonomic Dysregulation

Keywords

Polyvagal Theory; Trauma; Adversity; Anxiety; Depression; Mental Health; Emotional Health; Music; Social Connection; Embodiment; Autonomic Reactivity; Body Sensations; Relaxation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Music

EXPERIMENTAL

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

Interventions

Listening to Calming Music 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.

Music

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 at the Global Exchange Conference

You may not qualify if:

• Over the age of 89

Sponsors & Collaborators

• University of Florida: lead

Related Publications (5)

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

  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.

  PMID: 29193423 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 35849369 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Primary Dysautonomias; Wounds and Injuries; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Personal Satisfaction

Study Officials

• Lourdes P Dale, PhD

  UF College of Medicine Jacksonville, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 16, 2024
• Study Start: October 8, 2024
• Primary Completion: November 9, 2024
• Study Completion: April 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share