The Effect of Listening to Calming Music
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 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 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 augmented music.
- To identify individual characteristics that influence the immediate effects of listening to the augmented music.
Participants will:
PHASE 1:
- Complete the online pre- and post-surveys
- Listen to the brief music demo
- Listen to the full 15-minutes music session
PHASE 2:
- Complete the online pre- and post-surveys.
- Heart rate data will be collected continuously for about 25 minutes. It will be collected for 5 minutes before and after the intervention, and for 15 minutes during the intervention.
- Provide pre- and post- music saliva samples (1.5mL).
- Listen to full 15-minutes music session.
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 ANS reactivity 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
Phase 2: 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
- •Inclusion Criteria:
- •Between the ages of 18 and 89
- •Proficient in English
- •Attendees of an online workshop session
排除标准
- •- Over the age of 89
- •Inclusion Criteria:
- •Between the ages of 18 and 45
- •Proficient in English
- •Exclusion Criteria:
- •- Over the age of 45
研究组 & 干预措施
Augmented Theme
In phase 1:
Participants complete the pre-survey. After that, the participants will listen to a brief demo followed by the 15-minutes of augmented music. After completion of the music, the participants will complete the post-survey.
In phase 2:
Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants in the augmented group will receive 15-minutes of augmented music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.
干预措施: Augmented Theme (Behavioral)
Control Theme
In phase 2:
Participants complete the pre-survey, and provide 1.5-2mL of saliva. Then, they will be equipped with a HR band (polar exercise band). After that, the participants will receive 15-minutes of the control music. After completion of the music, Study Staff will have the participants provide 1.5-2mL of saliva and remove the HR belt. Following removal of the HR belt, the participants will complete the post-survey.
干预措施: Mahler 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 20-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 loneliness on the Effectiveness of Listening to Music using the UCLA Loneliness
时间窗: Baseline
This 20-item measure assesses how often a person feels disconnected from others. It is scored on a 4-point Likert scale (never = 1, rarely = 2, sometimes = 3, often = 4). The items are summed to calculate the total loneliness score, with higher scores indicating greater feelings of loneliness.
Assessing the Impact of hostility on the Effectiveness of Listening to Music using the Cook-Medley
时间窗: Baseline
This 60-item measure assesses the level of hostility and negative affectivity. It is scored on a true/false format, where responses are recorded as 1 for "true" and 0 for "false." The items are summed to determine the total hostility score, with higher scores indicating greater levels of hostility.
Assessing the Impact of cardiovascular risk on the Effectiveness of Listening to Music using the QRISK3
时间窗: Baseline
The QRISK3 is a risk assessment tool used to estimate the 10-year risk of developing cardiovascular disease. It is based on a variety of factors, including age, sex, blood pressure, cholesterol levels, smoking status, and medical history. The score is calculated using a point-based system, with higher scores indicating a higher risk of cardiovascular events. The result provides an estimated percentage of risk over the next 10 years.
次要结局
未报告次要终点