Effect of Relaxing Music on Blood Pressure and Resting Heart Rate

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147507
• Other study ID #: UMFB1012
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: September 21, 2020

Study information

• Verified date: November 2020
• Source: Universiti Tunku Abdul Rahman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 21, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Prehypertension
• Resting Heart Rate

Intervention

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.

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).

Locations

Country	Name	City	State
Malaysia	Universiti Tunku Abdul Rahman	Kajang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure change is being measured		At baseline (before intervention) and post intervention (end of 4 weeks)
Primary	Diastolic Blood Pressure change is being measured		At baseline (before intervention) and post intervention (end of 4 weeks)
Primary	Resting Heart Rate change is being measured		At baseline (before intervention) and post intervention (end of 4 weeks)