Musical Heart Rhythm RegulationNCT04268433
The MUSIC-HR Study
An observational study of Musical Heart Rhythm Regulation and Cardiovascular Diseases, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musical Heart Rhythm Regulation, Cardiovascular Diseases, Heart Rate Control
- What is being tested?
- N/A - Non-interventional study
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: As above.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital
London, Greater London, SW10 9NH
About this study
Official title: Musical Heart Rhythm Regulation: The MUSIC-HR Study
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.
- Hyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol.1918;46:35-38.
Read the detailed description
This is a single-arm non-randomized pilot study. Staff at Chelsea and Westminster NHS Foundation Trust will be recruited via the placement of posters in staff only areas such as staff rooms and via the daily communications that the Trust use. Those who meet all of the inclusion criteria and none of the exclusion criteria will be approached for participation in the study. The participants will be asked to listen to a series of musical genres, selected in random order, whilst lying on a standard hospital bed for comfort. This will take place in a private clinical room to minimise disturbance and any variation in heart rate caused by external stressors. The participants will have an ECG recording performed by attachment of adhesive surface lead electrodes to the chest and arms. This will be continuous throughout the protocol. They will also have a continuous non-invasive blood pressure recording using equipment that is in routine clinical practice (Finapress BP) and respiration monitored via a respiration belt. They will also be asked to wear a small lightweight sensor that gives readings of heart rate and blood pressure at 2 minute intervals.
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. (There will be a limit to the extent of the tempo adjustment, in order to prevent any noticeable distortion to the music.)
The tempo of the music is controlled by computer. The ECG recording will feed into the computer where the software alters the tempo of the music based on the real-time heart rate feedback. The hypothesis is that by altering the tempo of the music the investigators will see changes in the heart rate of the participant. These changes will then feedback to the software which will continue to alter the tempo accordingly with the aim to achieve a degree of heart rate control and see less heart rate variation and less high heart rates. It should take around one hour to complete all the study procedures.
- Being tested
- N/A - Non-interventional study
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A - Non-interventional studyOther
Stages:
- Patient information and written informed consent (3 Copies. To be carried out >24 hours after receiving the patient information sheet)
- Physiological recording set up (ECG, BP, sensor and respiratory band)
- Control period - no music played
- Series of pieces of music without tempo control
- Repeat series of pieces of music with tempo control
- Participant leaves the study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
As well as having an ECG recording performed, participants will also have a continuous non-invasive blood pressure recording using equipment that is in routine clinical practice (Finapress BP) and respiration monitored via a respiration belt. They will also be asked to wear a small lightweight sensor that gives readings of heart rate and blood pressure at 2 minute intervals.
The data obtained from all of the physiological recordings with be analysed for associations.
Measured: 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
As well as having an ECG recording performed, participants will also have a continuous non-invasive blood pressure recording using equipment that is in routine clinical practice (Finapress BP) and respiration monitored via a respiration belt. They will also be asked to wear a small lightweight sensor that gives readings of heart rate and blood pressure at 2 minute intervals.
The data obtained from all of the physiological recordings with be analysed for associations.
Measured: 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
Effect of music on markers of repolarization instability (QT interval and T wave vector assessment).
Measured: 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
This is assessed by frequency analysis of ECG.
Measured: 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
Respiration of participants will be monitored via a respiration belt whilst they are listening to music.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start26 Apr 2018
- Primary completion12 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musical Heart Rhythm RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- CW+ Charity
- Responsible party
- Sponsor
- Investigators
- Sadia Khan, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268433
- Sponsor's protocol ID
- C&W18/005
- Other IDs
- 242951
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol. 1918;46:35-38.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Heart Rhythm Regulation: The MUSIC-HR Study
- ClinicalTrials.gov ID
- NCT04268433
- Acronym / sponsor ID
- C&W18/005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- CW+ Charity
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Hyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol.1918;46:35-38.
Detailed description
This is a single-arm non-randomized pilot study. Staff at Chelsea and Westminster NHS Foundation Trust will be recruited via the placement of posters in staff only areas such as staff rooms and via the daily communications that the Trust use. Those who meet all of the inclusion criteria and none of the exclusion criteria will be approached for participation in the study. The participants will be asked to listen to a series of musical genres, selected in random order, whilst lying on a standard hospital bed for comfort. This will take place in a private clinical room to minimise disturbance and any variation in heart rate caused by external stressors. The participants will have an ECG recording performed by attachment of adhesive surface lead electrodes to the chest and arms. This will be continuous throughout the protocol. They will also have a continuous non-invasive blood pressure recording using equipment that is in routine clinical practice (Finapress BP) and respiration monitored via a respiration belt. They will also be asked to wear a small lightweight sensor that gives readings of heart rate and blood pressure at 2 minute intervals.
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. (There will be a limit to the extent of the tempo adjustment, in order to prevent any noticeable distortion to the music.)
The tempo of the music is controlled by computer. The ECG recording will feed into the computer where the software alters the tempo of the music based on the real-time heart rate feedback. The hypothesis is that by altering the tempo of the music the investigators will see changes in the heart rate of the participant. These changes will then feedback to the software which will continue to alter the tempo accordingly with the aim to achieve a degree of heart rate control and see less heart rate variation and less high heart rates. It should take around one hour to complete all the study procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- As above.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A - Non-interventional studyStages: 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 | Other | – |
Primary outcome
Assessment of the effect of music and music tempo on heart rate control
Time frame: 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.
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.
5 secondary outcomes
Assessment of the effect of music and music tempo on blood pressure and variability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- BackgroundHyde IM, Scalapino W. The influence of music upon electrocardiograms and blood pressure. Am J Physiol. 1918;46:35-38.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadia Khan principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musical Heart Rhythm Regulation and Cardiovascular Diseases, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effect of music and music tempo on heart rate control (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.