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Completed

NCT Number: NCT04147507

Effect of Relaxing Music on Blood Pressure and Resting Heart Rate

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Tunku Abdul Rahman

Kajang, Selangor, 43000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Systolic Blood Pressure change is being measured

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

  2. Diastolic Blood Pressure change is being measured

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

  3. Resting Heart Rate change is being measured

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

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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