The MUSIC-HR Study

NCT04268433 | Completed

• 2 other identifiers: C&W18/005242951
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The idea that music has an effect on heart rate and blood pressure has existed for some time. In 1918, Hyde and Scalapino \[1\] reported that minor tones increased pulse rate and lowered blood pressure, whereas "stirring" music increased both blood pressure and heart rate. In the management of many cardiovascular disorders heart rate control is paramount. Furthermore, many cardiovascular investigations (e.g. Cardiac CT) require adequate heart rate control in order to achieve diagnostic images and therefore results. Whilst pharmacologic therapy is available and remains the main strategy for heart rate control, this is not always without consequences. Side effect profiles, patient intolerance and also variable efficacy are limiting factors for pharmacological therapy. Alternative strategies to achieve adequate heart rate control are therefore needed. The aim of this study is to explore the potential use of music to control heart rates and other physiological parameters such as respiratory rate and blood pressure. The central study team hypothesize that by changing the tempo of the music they will be able to influence the natural variations in heart rate. 1\. Hyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol.1918;46:35-38.

Conditions

Musical Heart Rhythm Regulation; Cardiovascular Diseases; Heart Rate Control

Outcome Measures

Primary Outcomes (1)

• Assessment of the effect of music and music tempo on heart rate control

  After a period of approximately 10 minutes of ECG recording without music (control period), a series of pieces of music will be played whilst the ECG recordings continue. Each piece of music will last for no more than 5 minutes, 3 will be selected by the investigators and one will be pre-chosen by the participant prior to their attendance. The order in which these pieces will be played will be chosen at random. There will be a 3 minute recovery time in between each piece of music. The same pieces of music will then be played back to the participant but this time the music will subtly change tempo in reaction to the patient's heart rate. This is achieved by the ECG feeding data into the computer playing the music, whereupon the data is processed by Max MSP software and used to control the playback speed in Ableton Live. The algorithm for change is a linear one: the higher a patient's heart rate is in relation to a desired bpm target, the more the music will slow down.

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

Secondary Outcomes (5)

• Assessment of the effect of music and music tempo on blood pressure and variability

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

• Assessment of the effect of music on heart rate variability

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

• Assessment of the effect of music on markers of repolarization instability

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

• Effect of music on cardiac autonomics

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

• Assessment of the effect of music and music tempo on respiratory rate and variability

  Participants will be involved in the study for a total of 1 day. No follow-up is required so data will be ready for analysis after participants have completed the music exercise.

Interventions

N/A - Non-interventional study OTHER

Stages: 1. Patient information and written informed consent (3 Copies. To be carried out \>24 hours after receiving the patient information sheet) 2. Physiological recording set up (ECG, BP, sensor and respiratory band) 3. Control period - no music played 4. Series of pieces of music without tempo control 5. Repeat series of pieces of music with tempo control 6. Participant leaves the study

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above.

You may qualify if:

• Employed by Chelsea and Westminster NHS Foundation Trust with any contract type (substantive, fixed term, honorary or bank)
• Age 18 or above
• Capable of giving informed consent
• Normal 12 lead ECG and blood pressure recording

You may not qualify if:

• Under 18 years of age
• Incapable of giving informed consent
• Regular use of any medications that interact with physiological control of the parameters being measured
• Hearing impairment
• Skin sensitivity to ECG electrodes

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• CW+ Charity: collaborator

Study Sites (1)

Chelsea and Westminster Hospital

London, Greater London, SW10 9NH, United Kingdom

Location

Related Publications (1)

• Hyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol. 1918;46:35-38.

  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sadia Khan

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: April 26, 2018
• Primary Completion: July 12, 2019
• Study Completion: September 30, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)