- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147507
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
Completed
Conditions
Intervention / Treatment
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
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Selangor
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Kajang, Selangor, Malaysia, 43000
- Universiti Tunku Abdul Rahman
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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 |
|---|---|
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Experimental: Music Therapy
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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.
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Other: Control
Life style Modification.
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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).
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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)
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At baseline (before intervention) and post intervention (end of 4 weeks)
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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)
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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.