Effect of Relaxing Music on Blood Pressure and Resting Heart Rate
Primary Purpose
Prehypertension, Blood Pressure, Resting Heart Rate
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Passive Music Therapy
Control
Sponsored by
About this trial
This is an interventional treatment trial for Prehypertension
Eligibility Criteria
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
Sites / Locations
- Universiti Tunku Abdul Rahman
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Music Therapy
Control
Arm Description
Life style Modification.
Outcomes
Primary Outcome Measures
Systolic Blood Pressure change is being measured
Diastolic Blood Pressure change is being measured
Resting Heart Rate change is being measured
Secondary Outcome Measures
Full Information
NCT ID
NCT04147507
First Posted
October 29, 2019
Last Updated
November 22, 2020
Sponsor
Universiti Tunku Abdul Rahman
1. Study Identification
Unique Protocol Identification Number
NCT04147507
Brief Title
Effect of Relaxing Music on Blood Pressure and Resting Heart Rate
Official Title
Effect of Relaxing Music on Blood Pressure and Resting Heart Rate Among Pre-hypertensive Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
September 14, 2020 (Actual)
Study Completion Date
September 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Quota sampling will be used as the sampling method. Investigators would recruit 30 participants for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Blood Pressure, Resting Heart Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Arm Description
Life style Modification.
Intervention Type
Other
Intervention Name(s)
Passive Music Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
Systolic Blood Pressure change is being measured
Time Frame
At baseline (before intervention) and post intervention (end of 4 weeks)
Title
Diastolic Blood Pressure change is being measured
Time Frame
At baseline (before intervention) and post intervention (end of 4 weeks)
Title
Resting Heart Rate change is being measured
Time Frame
At baseline (before intervention) and post intervention (end of 4 weeks)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male participants with prehypertension.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universiti Tunku Abdul Rahman
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data (IPD) available to other researchers
Learn more about this trial
Effect of Relaxing Music on Blood Pressure and Resting Heart Rate
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