Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients

December 20, 2017 updated by: Praew Kotruchin, Khon Kaen University

Instrumental Folk Music Listening Reduced Home Blood Pressure in Stage-2 Hypertensive Patients; a Randomized Controlled Trial

A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province, Thailand. Sixty participants were randomized to music listening group and control group. The music listening group was assigned to listen to 30-minute instrumental folk music everyday for one month. Home BP and office BP were monitored and recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Thailand
    • Muang
      • Khon Kaen, Muang, Thailand, 40002
        • Emergency Medicine, Khon Kaen University

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40-80 years old
  • Diagnosed stage-2 hypertension (HT) (defined by office systolic blood pressure >= 140mm Hg and/or diastolic blood pressure >= 90 mm Hg at first hospital visit)

Exclusion Criteria:

  • Pregnant women, white-coat HT, secondary HT and hearing loss or blind.

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
Experimental: music listening
Participants who were randomized into intervention group were assigned to listen to the music everyday (day 1st to day 30th), at anytime of day that was suitable with their lifestyles but not at the time of BP measurement. During day 31st -120th, participants did not listen to the music. Other treatment was the same as the control arm.
Other: instrumental folk music
The music was composed and edited by a professor of Folk Musical Department, Faculty of Arts, Khon Kaen University. There were total of 6 songs, 32-minute length. The music was slow-instrumental, 60-80 beats per minute and ranged between 40-60 decibel levels.
No Intervention: control
control arm received conventional hypertension treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of home systolic and diastolic blood pressure at day 30th
Time Frame: Day 0th (baseline) to day 30th.
Home blood pressure of participant was monitored and recorded.
Day 0th (baseline) to day 30th.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of office systolic and diastolic blood pressure at day 120th
Time Frame: Day 0th and day 120th
Office blood pressure was measured at day 0th (baseline) and at day 120th (3-month follow up).
Day 0th and day 120th

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 23, 2015

Primary Completion (Actual)

May 31, 2016

Study Completion (Actual)

December 17, 2017

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE581320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data is available when contact and request to the correspondence author or principal investigator.

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.

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