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

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

    • 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

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
Intervention / Treatment
Experimental: 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.
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

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.

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)

February 10, 2020

Primary Completion (Actual)

September 14, 2020

Study Completion (Actual)

September 21, 2020

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID 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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