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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381820
Other study ID # HE581320
Secondary ID
Status Completed
Phase N/A
First received December 18, 2017
Last updated December 20, 2017
Start date November 23, 2015
Est. completion date December 17, 2017

Study information

Verified date December 2017
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 17, 2017
Est. primary completion date May 31, 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Hypertension
  • Musical Therapy as a Complementary Treatment of Hypertension

Intervention

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.

Locations

Country Name City State
Thailand Emergency Medicine, Khon Kaen University Khon Kaen Muang

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of home systolic and diastolic blood pressure at day 30th Home blood pressure of participant was monitored and recorded. Day 0th (baseline) to day 30th.
Secondary Change from baseline of office systolic and diastolic blood pressure at day 120th Office blood pressure was measured at day 0th (baseline) and at day 120th (3-month follow up). Day 0th and day 120th