Cardiovascular Effects of Music Versus Guided Mindfulness: A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Blood Pressure
研究概览
简要总结
The purpose of this study is to examine how listening to music compares to guided mindfulness in affecting blood pressure, heart rate, and feelings of anxiety in healthy adults. The investigators aim to determine whether one of these approaches is more effective in reducing these variables. Additionally, the study will explore whether personal traits or preferences, measured using questionnaires, influence how participants respond to music or mindfulness. Based on previous clinical findings, the researchers hypothesize that listening to music will lead to greater reductions in blood pressure and heart rate compared to guided mindfulness.
详细描述
Music and mindfulness-based practices, such as meditation and breathing exercises, are well-established non-pharmacological interventions known to positively influence both physiological and psychological health. They are utilized for their ability to reduce stress and promote relaxation by modulating autonomic nervous system activity, which in turn influences the cardiovascular system. This modulation has been associated with reductions in markers of physiological stress, such as blood pressure and heart rate.
Cardiovascular influences of music and mindfulness have been leveraged in numerous medical procedures for enhancing comfort and tolerability, as well as mental well-being. However, despite the widespread use and documented physiological effects of music and mindfulness-based interventions, there is a lack of research directly comparing their effects. Furthermore, there is a relative lack of high-quality randomized trials examining the effects of music and mindfulness on parameters such as blood pressure and heart rate.
This randomized crossover study will examine the cardiovascular impact of listening to a curated music playlist versus participating in a guided mindfulness session in a healthy population to determine whether music produces greater reductions in blood pressure and heart rate than guided mindfulness.
Each participant will attend a single 3-hour study visit, during which they will take part in two sessions. One session involves listening to a carefully selected music playlist, and the other involves participating in a guided mindfulness exercise. The order of the sessions will be random. Blood pressure and heart rate will be measured throughout the study visit, and participants will be asked to complete questionnaires measuring anxiety, experience with music and mindfulness, tendency to become deeply engaged, and enjoyment of each session.
The primary aim is to compare changes in systolic blood pressure, diastolic blood pressure, and heart rate between curated music playlist and guided mindfulness interventions, using an automated oscillometric upper arm blood pressure monitor with measurements taken at 10-minute intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal baseline blood pressure (systolic BP < 120 mmHg and diastolic BP < 80mmHg).
- •Abstention from caffeine intake for at least 12 hours before the study session and throughout the session, as caffeine may influence cardiovascular measurements.
- •Abstention from using nicotine or tobacco products for at least 1 hour before the study session and throughout the session, as these substances may influence cardiovascular measurements.
排除标准
- •Significant hearing impairments that cannot be improved with hearing aids or sound amplification.
- •Current use of medications that could affect blood pressure.
- •History of hypertension or cardiovascular disease.
- •Diagnosis of active substance use disorder, or reported patterns of alcohol, cannabis, or recreational/non-prescribed substance use likely to affect cardiovascular function.
研究组 & 干预措施
Mindfulness Intervention First
Participants randomized to this arm will receive a 40-minute Guided Mindfulness intervention in the first period, followed by a 20-minute washout period, and then receive a 40-minute Music Listening intervention in the second period.
干预措施: Mindfulness (Other)
Music Intervention First
Participants randomized to this arm will receive a 40-minute Music Listening intervention in the first period, followed by a 20-minute washout period, and then receive a 40-minute Guided Mindfulness intervention in the second period.
干预措施: Music (Other)
Music Intervention First
Participants randomized to this arm will receive a 40-minute Music Listening intervention in the first period, followed by a 20-minute washout period, and then receive a 40-minute Guided Mindfulness intervention in the second period.
干预措施: Mindfulness (Other)
Mindfulness Intervention First
Participants randomized to this arm will receive a 40-minute Guided Mindfulness intervention in the first period, followed by a 20-minute washout period, and then receive a 40-minute Music Listening intervention in the second period.
干预措施: Music (Other)
结局指标
主要结局
Changes in Blood Pressure
时间窗: 0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.
The investigators will compare changes in systolic and diastolic blood pressure between the curated music playlist and guided mindfulness interventions using an automated oscillometric upper arm blood pressure monitor with measurements taken at 10-minute intervals.
Changes in Heart Rate
时间窗: 0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.
The investigators will compare changes in heart rate between the curated music playlist and guided mindfulness interventions using an automated oscillometric upper arm blood pressure monitor with measurements taken at 10-minute intervals.
Changes in Blood Pressure
时间窗: 0, 5, 10, 15, 20, 25, 30, 35, and 40 minutes during each 40-minute intervention session.
The investigators will compare changes in systolic and diastolic blood pressure between the curated music playlist and guided mindfulness interventions using an automated oscillometric upper arm blood pressure monitor with measurements taken in triplicate at 5-minute intervals.
Changes in Heart Rate
时间窗: 0, 5, 10, 15, 20, 25, 30, 35, and 40 minutes during each 40-minute intervention session.
The investigators will compare changes in heart rate between the curated music playlist and guided mindfulness interventions using an automated oscillometric upper arm blood pressure monitor with measurements taken in triplicate at 5-minute intervals.
次要结局
- Change from Baseline in Edmonton Symptom Assessment System (ESAS)(Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.)
- Subjective Enjoyment (Visual Analogue Scale and Open-Ended Questions)(Immediately after each of the two 40-minute intervention sessions during the single study visit.)
- Changes in Beat-to-Beat Blood Pressure (Finapres NOVA)(0 to 40 minutes during each 40-minute intervention session.)
- Changes in Heart Rate (Finapres NOVA, Electrocardiogram-derived)(0 to 40 minutes during each 40-minute intervention session.)
- Change from Baseline in STAI-Y 1(Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.)
- Barcelona Music Reward Questionnaire (BMRQ)(Baseline)
- MUSE questionnaire(Baseline)
- Mindfulness Adherence Questionnaire (MAQ)(Baseline)
- Modified Tellegen Absorption Scale (MODTAS)(Baseline)
- Subjective Enjoyment (Visual Analogue Scale)(Immediately after each of the two 40-minute intervention sessions during the single study visit.)
研究者
Kyle Greenway
Psychiatrist
Sir Mortimer B. Davis - Jewish General Hospital