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Идёт набор NCT07338500

Cardiovascular Effects of Music Versus Guided Mindfulness

Без фазы С лечением Music Listening Intervention Mindfulness-based Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Music, Mindfulness.
Кому может быть актуально
Состояния в реестре: Music Listening Intervention, Mindfulness-based Intervention. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Cardiovascular Effects of Music Versus Guided Mindfulness: A Randomized Crossover Study

Обзор

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.

Подробное описание

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.

By investigating the physiological effects of music versus guided mindfulness on hemodynamic responses in a healthy population, this study will provide critical insight into the distinct and shared autonomic effects of these two non-pharmacological interventions. Understanding the cardiovascular effects of music and guided mindfulness will inform evidence-based guidelines for integrating these interventions into clinical and research protocols. As non-invasive therapeutic tools, both music and mindfulness hold promise for enhancing patient care across diverse settings.

Вмешательства

  • Другое Music
    Participants will listen to a 40-minute playlist, curated by the research team, through noise-cancelling headphones. The playlist will simultaneously be played in the room through speakers.
  • Другое Mindfulness
    Participants will engage in a structured mindfulness session led by a member of the research team with experience in mindfulness-based practices.

Первичные конечные точки

  • Changes in Blood Pressure [Срок оценки: 0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.]
  • Changes in Heart Rate [Срок оценки: 0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.]
Вторичные конечные точки (9)
  • Changes in Beat-to-Beat Blood Pressure (Finapres NOVA) [Срок оценки: 0 to 40 minutes during each 40-minute intervention session.]
  • Changes in Heart Rate (Finapres NOVA, Electrocardiogram-derived) [Срок оценки: 0 to 40 minutes during each 40-minute intervention session.]
  • Change from Baseline in STAI-Y 1 [Срок оценки: Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.]
  • Change from Baseline in Edmonton Symptom Assessment System (ESAS) [Срок оценки: Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.]
  • Barcelona Music Reward Questionnaire (BMRQ) [Срок оценки: Baseline]
  • MUSE questionnaire [Срок оценки: Baseline]
  • Mindfulness Adherence Questionnaire (MAQ) [Срок оценки: Baseline]
  • Modified Tellegen Absorption Scale (MODTAS) [Срок оценки: Baseline]
  • Subjective Enjoyment (Visual Analogue Scale and Open-Ended Questions) [Срок оценки: Immediately after each of the two 40-minute intervention sessions during the single study visit.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • Jewish General Hospital — Montreal

Идентификаторы

NCT: NCT07338500 · 2026-4674

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗