Effect of Relaxing Music on Blood Pressure and Resting Heart Rate

NCT04147507 | Completed

• 1 other identifier: UMFB1012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehypertension; Blood Pressure; Resting Heart Rate

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure change is being measured

  At baseline (before intervention) and post intervention (end of 4 weeks)

• Diastolic Blood Pressure change is being measured

  At baseline (before intervention) and post intervention (end of 4 weeks)

• Resting Heart Rate change is being measured

  At baseline (before intervention) and post intervention (end of 4 weeks)

Study Arms (2)

Music Therapy

EXPERIMENTAL

Other: Passive Music Therapy

Control

OTHER

Life style Modification.

Behavioral: Control

Interventions

Passive Music Therapy OTHER

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.

Music Therapy

Control BEHAVIORAL

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).

Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Only male participants with prehypertension.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 1, 2019
• Study Start: February 10, 2020
• Primary Completion: September 14, 2020
• Study Completion: September 21, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)