- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07338500
Cardiovascular Effects of Music Versus Guided Mindfulness (CMM)
Cardiovascular Effects of Music Versus Guided Mindfulness: A Randomized Crossover Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Misener, BSc
- Phone Number: 6138127874
- Email: elizabeth.misener@mail.mcgill.ca
Study Contact Backup
- Name: Sara de la Salle, PhD
- Email: sara.delasalle@mail.mcgill.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Recruiting
- Jewish General Hospital
-
Contact:
- Elizabeth Misener, BSc
- Phone Number: 6138127874
- Email: elizabeth.misener@mail.mcgill.ca
-
Contact:
- Sara de la Salle, PhD
- Email: sara.delasalle@mail.mcgill.ca
-
Principal Investigator:
- Kyle Greenway, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Participants will engage in a structured mindfulness session led by a member of the research team with experience in mindfulness-based practices.
|
|
Experimental: 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.
|
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.
Participants will engage in a structured mindfulness session led by a member of the research team with experience in mindfulness-based practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Blood Pressure
Time Frame: 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.
|
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.
|
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.
|
0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Heart Rate (Finapres NOVA, Electrocardiogram-derived)
Time Frame: 0 to 40 minutes during each 40-minute intervention session.
|
Heart rate will be recorded continuously using the electrocardiogram (ECG) channel of the Finapres NOVA, a non-invasive continuous hemodynamic monitoring technology (Finapres Medical Systems, Netherlands).
Heart rate values will be derived from the ECG signal.
This will allow for more detailed characterization of the cardiovascular response to music and mindfulness, potentially capturing effects on heart rate not detected by periodic arm-cuff measurements.
|
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.
|
The investigators will measure changes in acute anxiety using the State-Trait Anxiety Scale (STAI) - State subscale (form Y1) before and after each intervention.
The STAI consists of 20 participant-rated statements, from 1 to 4 (1= Not at all, 4= Very much so) regarding their current anxiety (state).
A lower score corresponds to less severity of symptoms.
|
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
|
The Barcelona Music Reward Questionnaire (BMRQ) is a validated 20-item questionnaire used to assess individual differences in the rewarding aspects of music listening.
Each item is a statement rated on a 5-point Likert scale (1 = "Completely Disagree" to 5 = "Completely Agree").
Higher scores indicate a greater sensitivity to music-related reward.
The total and subscale scores will be used to determine whether the extent of music reward experienced by participants predicts the magnitude of cardiovascular impact.
|
Baseline
|
|
MUSE questionnaire
Time Frame: Baseline
|
The MUSE questionnaire includes two quantitative items assessing average weekly and daily hours of music listening, as well as three 5-point Likert scale items evaluating the subjective importance of music, frequency of listening, and preference for specific genres.
It will be used to characterize participants' music listening habits and attitudes and their relationship to cardiovascular outcomes.
|
Baseline
|
|
Mindfulness Adherence Questionnaire (MAQ)
Time Frame: Baseline
|
The Mindfulness Adherence Questionnaire (MAQ) is designed to measure the quantity and quality of an individual's mindfulness practice.
It includes two quantitative items assessing frequency of formal practice and average duration of each session, as well as ten 5-point Likert scale items evaluating quality of mindfulness practice and time spent being mindful in everyday life, outside of formal sessions.
It will be used to evaluate participants' experience with mindfulness and its relationship to cardiovascular outcomes.
|
Baseline
|
|
Modified Tellegen Absorption Scale (MODTAS)
Time Frame: Baseline
|
The Modified Tellegen Absorption Scale (MODTAS) is a validated 34-item questionnaire designed to measure an individual's engagement or immersion in sensory or imaginative experiences.
Each item is rated on a 5-point Likert scale.
It will be used to explore whether individual differences in trait absorption predict responsiveness to music and mindfulness interventions.
|
Baseline
|
|
Changes in Beat-to-Beat Blood Pressure (Finapres NOVA)
Time Frame: 0 to 40 minutes during each 40-minute intervention session.
|
Continuous beat-to-beat blood pressure will be recorded using Finometer Model 2 hemodynamic monitoring technology (Finapres Medical Systems, Netherlands) to allow for more detailed characterization of the cardiovascular response to music and mindfulness, potentially capturing effects on systolic and diastolic blood pressure not detected by periodic arm-cuff measurements.
|
0 to 40 minutes during each 40-minute intervention session.
|
|
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.
|
The investigators will measure changes in common symptoms using the ESAS before and after each intervention.
The ESAS consists of 10 common symptoms: pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, well-being, and other, rated from 0 to 10.
A lower score corresponds to less severity of symptoms.
|
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)
Time Frame: Immediately after each of the two 40-minute intervention sessions during the single study visit.
|
The investigators will assess subjective enjoyment of each intervention using 10-point visual analogue scales (VAS) administered immediately following each session.
Participants will rate their enjoyment on a horizontal scale ranging from 0 ("not at all enjoyable") to 10 ("extremely enjoyable").
Additionally, participants will be asked a series of open-ended questions about their experience of each intervention.
Including these measures will allow for assessment of potential preference effects that could influence cardiovascular outcomes.
|
Immediately after each of the two 40-minute intervention sessions during the single study visit.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kyle Greenway, MD, Sir Mortimer B. Davis - Jewish General Hospital, McGill University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-4674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Music Listening Intervention
-
Toronto Metropolitan UniversitySocial Sciences and Humanities Research Council of CanadaNot yet recruitingLoneliness | Social Connectedness | Music Listening InterventionCanada
-
Akdeniz UniversityCompletedChild | Mobility | Appendectomy | Mobilization | Music Listening InterventionTurkey
-
Centre Hospitalier Universitaire de BesanconCompleted
-
McGill UniversitySt. Mary's Hospital FoundationRecruitingInsomnia | Sleep Disturbance | Music Listening Intervention | Non-musical Sound Listening InterventionCanada
-
Aydin Adnan Menderes UniversityActive, not recruitingOperation Time | Music Listening | UreteroscopyTurkey
-
Johns Hopkins UniversitySteven & Alexandra Cohen FoundationEnrolling by invitationPsilocybin | Music InterventionUnited States
-
Balikesir UniversityCompletedEffect Of Lıstenıng to Musıc on Women Gıvıng Bırth By Cesarean Sectıon: Paın, Comfort And AttachmentCesarean Delivery | Music ListeningTurkey (Türkiye)
-
Uşak UniversityRecruitingMusic Intervention | Breathing ExercisesTurkey (Türkiye)
-
University of ValenciaRecruitingPhysical Activity | Music Intervention | Fundamental Motor SkillsSpain
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
Clinical Trials on Music
-
Azad University of Medical SciencesCompleted
-
Ente Ospedaliero Cantonale, BellinzonaCompleted
-
Toronto Metropolitan UniversitySocial Sciences and Humanities Research Council of CanadaNot yet recruitingLoneliness | Social Connectedness | Music Listening InterventionCanada
-
Ankara Diskapi Training and Research HospitalCompleted
-
The University of Texas Health Science Center at...Completed
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Da-Yeh UniversityNot yet recruitingAnxiety | Blood Pressure | Heart Rate | Heart Rate Variability (HRV)
-
Corporacion Parc TauliRecruitingDistal Radius Fracture ReductionSpain
-
Ankara Diskapi Training and Research HospitalCompleted