The Impact of Enhanced Music & Natural Visuals on Emotional Health

Purpose

The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities. The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.

Conditions

  • Emotion Management Skills
  • Lifestyle, Healthy
  • Lifestyle Intervention
  • Recovery
  • Exercise and Recovery
  • Exercise Training
  • Anxiety and Mood Disorders
  • Sleep
  • Motivation
  • Comfort
  • Pain Management
  • Rehabilitation
  • Creativity and Mindfulness

Eligibility

Eligible Ages
Over 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • You are 13 years of age or older - You can read, write, and speak English at a 5th-grade level or higher - You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants) - To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study - You are willing and able to use the sound-delivery and data-collection apparatus of this study - You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds/headphones and/or a "smart" device with internet and/or Bluetooth access (e.g., smartphone, iPad). - You have normal hearing in both ears. - You never experience ringing noises or buzzing sensations in your ears (tinnitus) - You do not use a heart/cardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks - You have no known history of fainting, fainting, spells or seizures, spinning sensations, or trouble with balance (medical terms include epilepsy, seizures, syncope, vertigo, nystagmus) - You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam/Valium, lorazepam/Ativan or clonazepam/Klonopin), or acute or chronic pain medications (including narcotics and codeine) - For any study session, you will not be under the influence of any substances that could prevent safe participation and will not have consumed e.g., alcohol, THC, Psilocybin, or other mood-altering drugs in the 12 hours preceding the session.

Exclusion Criteria

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Group A will be given access to the intervention (use of the soundBrilliance app) for 12 weeks. Group B will receive no intervention (behavior as usual) for 12 weeks. Sub-groups within the cohort such as low-no trait anxiety or stress as measured by State Trait Anxiety Inventory - Trait (STAI-T) and Perceived Stress Scale (PSS) categories respectively, will also be analyzed for differences. Subgroups also include age and sex. Statistical models will include baseline age, sex, STAI-T and PSS categories, treatment arm and time as predictors. Physiological measures will be taken on a select sub-group of participant in the treatment arm. At completion of 12 weeks, Group A will be invited to continue the intervention for a further 12 weeks and Group B will be invited to crossover to receive the intervention for 12 weeks.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group A - Intervention 		Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks
  • Device: soundBrilliance software application - Emotional Health
    Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.
No Intervention
Group B 		Group B will receive no intervention (behavior as usual) for 12 weeks.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
soundBrilliance LLC

Study Contact

Robert Mele (VP of Clinical Research & Testing Operations), B.Eng
7752444866
rob.mele@soundBrilliance.com

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