Effect of Relaxing Music on Blood Pressure and Resting Heart Rate

November 22, 2020 updated by: Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman

Effect of Relaxing Music on Blood Pressure and Resting Heart Rate Among Pre-hypertensive Young Adults

Prehypertention is defined as systolic blood pressure between 120 and 139 mmHg and/or diastolic blood pressure between 80 and 89 mmHg. People with prehypertension have the higher risk to develop hypertension compared to people with normal blood pressure (normotensive) especially when getting old, therefore prehypertension is known for preliminary stage of hypertension. Framingham Heart Study have shown the progression rate from prehypertension to hypertension was as high as 19% over 4 years. Prehypertension will also lead to abnormality of the cardiovascular system. Thus it is very important to identify the prehypertension at early stage, so that steps can be taken to slow down the progression to hypertension and to normalize the blood pressure level. Minimal reduction in blood pressure produce a large benefit to human health, as stated in JNC (Joint National Committee) VII report, a 5mmHg decrease in systolic blood pressure would be able to reduce as much as 9% mortality rate caused by coronary heart disease, 14% mortality related to stroke, and 7% decrease in all-cause mortality. Previous studies have focused on effect of music therapy in hypertensive elderly, prehypertensive pregnant women, prehypertensive elderly but no research has been conducted on prehypertensive young adults. In addition, prehypertension increase risk of developing cardiovascular disease, thus early intervention is needed to prevent the progression of prehypertension to hypertension status and normalize the blood pressure level.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Quota sampling will be used as the sampling method. Investigators would recruit 30 participants for this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Universiti Tunku Abdul Rahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Systolic blood pressure between 120 to 139 mmHg
  • Diastolic blood pressure between 80 to 89 mmHg
  • Not having any hearing impairment and able to listen to music using headphone
  • Willing to participate in this study

Exclusion Criteria:

  • Under influence of any medication that would affect the concentration
  • Systolic Blood pressure of less than 120 or more than 140 mmHg
  • Diastolic blood pressure of less than 80 or more than 90 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music Therapy
Other: Passive Music Therapy
Music group (N=15) will receive listen to music therapy passively for 20 minutes/day, 5 days/week for 4 weeks, along with lifestyle modifications. Music therapy will be provided via headphones in an isolated quiet non-disrupted room, with room temperature maintained between 20-22 degree Celsius and having medium light intensity. Participants would be instructed to listen to music with eyes closed in sitting position, back supported in comfortable position on a chair. The participants will be given 5 minutes' rest in sitting position before and after each music therapy session.
Other: Control
Life style Modification.
Behavioral: Control
Control group (N=15) would receive only lifestyle modification. Handout of lifestyle modification according to the Seventh Joint National Committee (JNC VII) report guidelines will be given to all participants. Participants would be instructed to not participate in any form of physical activity and to focus only on two components from the guideline which includes practice the DASH eating plan (diet rich in fruits and vegetables, low fat dairy or unsaturated fat) and limit the daily sodium intake (less than 100 mmol per day).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Systolic Blood Pressure change is being measured
Time Frame: At baseline (before intervention) and post intervention (end of 4 weeks)
At baseline (before intervention) and post intervention (end of 4 weeks)
Diastolic Blood Pressure change is being measured
Time Frame: At baseline (before intervention) and post intervention (end of 4 weeks)
At baseline (before intervention) and post intervention (end of 4 weeks)
Resting Heart Rate change is being measured
Time Frame: At baseline (before intervention) and post intervention (end of 4 weeks)
At baseline (before intervention) and post intervention (end of 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Tunku Abdul Rahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMFB1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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