Cardiovascular Effects of Music Versus Guided Mindfulness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSir Mortimer B. Davis - Jewish General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Music
Other interventionParticipants 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.
Mindfulness
Other interventionParticipants will engage in a structured mindfulness session led by a member of the research team with experience in mindfulness-based practices.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Music Intervention FirstExperimental treatment 2 interventions
Group B: Mindfulness Intervention FirstExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in Blood Pressure
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.
Time frame
0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.2
Changes in Heart Rate
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.
Time frame
0, 10, 20, 30, and 40 minutes during each 40-minute intervention session.Secondary outcomes
1
Changes in Beat-to-Beat Blood Pressure (Finapres NOVA)
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.
Time frame
0 to 40 minutes during each 40-minute intervention session.2
Changes in Heart Rate (Finapres NOVA, Electrocardiogram-derived)
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.
Time frame
0 to 40 minutes during each 40-minute intervention session.3
Change from Baseline in STAI-Y 1
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.
Time frame
Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.4
Change from Baseline in Edmonton Symptom Assessment System (ESAS)
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.
Time frame
Baseline and immediately after each of the two 40-minute intervention sessions during the single study visit.Sponsors and contacts
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Source ClinicalTrials.gov