Potential Benefits of Sonic Augmentation Technology in Music for Improving Health and Wellness
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
研究概览
简要总结
The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music enhanced with Sonic Augmentation Technology (SAT) can improve health and wellness. The main goals of the study are:
- To examine the immediate effects of listening to the augmented music.
- To identify individual characteristics that influence the immediate effects of listening to the augmented music.
Participants will:
- Complete the online pre- and post-surveys.
- Provide pre- and post- music saliva samples (1.5mL).
- Listen to the full 15-minutes music session via over-ear headphones.
详细描述
The purpose of the current study is to explore the effects of listening to 15-minutes of sonic augmented music on subjective feelings of calmness and autonomic state.
Specific Aims:
Specific Aim 1: To investigate whether pre-intervention measures of current functioning relate to the overall functioning of the participants.
•The investigators 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be randomly assigned via a random number generator to either the augmented group or the control group. The participant will be blinded to the group they are assigned to.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 89
- •Proficient in English
- •Employed at UF Health Jacksonville
排除标准
- •Over the age of 89
研究组 & 干预措施
Augmented Theme
Participants complete the pre-survey, and provide 1.5-2mL of saliva. After that, the participants will receive 15-minutes of the augmented music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and complete the post-survey.
干预措施: Augmented Theme (Behavioral)
Mozart Theme
Participants complete the pre-survey, and provide 1.5-2mL of saliva. After that, the participants will receive 15-minutes of the control music featuring a Mozart composition. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and complete the post-survey.
干预措施: Mozart Theme (Behavioral)
结局指标
主要结局
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
时间窗: Baseline
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
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
时间窗: Baseline
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.
Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
时间窗: From baseline through study completion, an average of 90 minutes
This 12-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.
Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7
时间窗: Baseline
This 7-item measure assesses the severity of generalized anxiety symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to calculate the total anxiety score, with higher scores indicating more severe anxiety symptoms.
Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8
时间窗: Baseline
This 8-item measure assesses the severity of depressive symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to determine the total depression score, with higher scores indicating greater severity of depressive symptoms.
Assessing the Impact of PTSD on the Effectiveness of Listening to Music using the PCL-5
时间窗: Baseline
This 8-item measure assesses the severity of depressive symptoms. It is scored on a 5-point Likert scale (not at all = 0, a little bit = 1, moderately = 2, quite a bit = 3, 4 = extremely). The items are summed to determine the total PTSD score, with higher scores indicating greater severity of PTSD symptoms.
Assessing the Impact of Moral Injury on the Effectiveness of Listening to Music using the Moral Injury Events Scale
时间窗: Baseline
This 6-item measure assesses the level of agreement about the occurrence and anguish of moral injury (asked as two separate questions) experienced by participants themselves (self moral injury or Self MI) and observed by participants in others (others moral injury or Others MI). It is scored on a 5-point Likert scale (strongly disagree = 1, Moderately Disagree = 2, 3 = disagree, 4 = agree, 5 = moderately agree, 6 = strongly agree).
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
时间窗: Baseline
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.
Assessing the Impact of Autonomic Reactivity using the Body Perceptions Inventory Short Form
时间窗: Baseline
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
Measuring Change in subjective feelings of calmness and autonomic state using the Benefits List
时间窗: From baseline through study completion, an average of 90 minutes
This 12-item measure, which assesses subjective feelings of calmness and autonomic state was created for this study.
Assessing the Impact of anxiety on the Effectiveness of Listening to Music using the GAD-7
时间窗: Baseline
This 7-item measure assesses the severity of generalized anxiety symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to calculate the total anxiety score, with higher scores indicating more severe anxiety symptoms.
Assessing the Impact of depression on the Effectiveness of Listening to Music using the PHQ-8
时间窗: Baseline
This 8-item measure assesses the severity of depressive symptoms. It is scored on a 4-point Likert scale (not at all = 0, several days = 1, more than half the days = 2, nearly every day = 3). The items are summed to determine the total depression score, with higher scores indicating greater severity of depressive symptoms.
次要结局
未报告次要终点