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Recruiting NCT07338500

Cardiovascular Effects of Music Versus Guided Mindfulness

No phase Interventional Music Listening Intervention Mindfulness-based Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music, Mindfulness.
Who it may be relevant to
Registry conditions: Music Listening Intervention, Mindfulness-based Intervention. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other Mindfulness
    Participants will engage in a structured mindfulness session led by a member of the research team with experience in mindfulness-based practices.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • Jewish General Hospital — Montreal

Identifiers

NCT: NCT07338500 · 2026-4674

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗