Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.
时间窗: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
The 20 item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.
Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups.
时间窗: Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline).
The 8 item PHQ-8, a self-report survey reflecting current symptoms of depression, will be given to both groups at baseline and at 20week intervals through the duration of the 12-week protocol. The difference in group mean change of PHQ-8 from baseline across 2-week milestones will be estimated.
Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) between treatment vs control groups.
时间窗: Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
The 20 item PANAS-SF will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of positive and negative affect scores from baseline across 2-week milestones will be estimated.
次要结局
- Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.(Baseline and at week 12 (0, 12 weeks post-baseline).)
- Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.(Baseline and at week 12 (0, 12 weeks post-baseline).)
- Change in Beck Depression Inventory-II (21 item; BDI-II) between treatment vs control groups.(Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).)
- Planned Sub-group Analysis of Age(Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of Sex(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of baseline scores of PSS(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of baseline scores of Cantril's Ladder(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of baseline scores of MAIA(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Planned Sub-group Analysis of baseline scores of MAAS(Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).)
- Summarization of subjective Tolerance of stimuli(Tolerance data collected at completion of sessions, over the duration of 12-week protocol.)
- Summarization of subjective Satisfaction with stimuli(Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.)
- Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session.(Pre and post stimuli for each treatment session over the duration of 12-week protocol)
- Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session.(Pre and post stimuli for each treatment session over the duration of 12-week protocol.)
- Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis)(Pre and post stimuli for each treatment session over the duration of 12-week protocol)