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

• ClinicalTrials.gov Identifier: NCT03381820
• Recruitment Status: Completed
• First Posted: December 22, 2017
• Last Update Posted: December 22, 2017
• Sponsor: Khon Kaen University
• Information provided by (Responsible Party): Praew Kotruchin, Khon Kaen University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Musical Therapy as a Complementary Treatment of Hypertension	Other: instrumental folk music	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised control trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Instrumental Folk Music Listening Reduced Home Blood Pressure in Stage-2 Hypertensive Patients; a Randomized Controlled Trial
• Actual Study Start Date: November 23, 2015
• Actual Primary Completion Date: May 31, 2016
• Actual Study Completion Date: December 17, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Thailand

Emergency Medicine, Khon Kaen University

Khon Kaen, Muang, Thailand, 40002

Sponsors and Collaborators

Khon Kaen University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Im-Oun S, Kotruchin P, Thinsug P, Mitsungnern T, Techa-Atik P, Pongchaiyakul C. Effect of Thai instrumental folk music on blood pressure: A randomized controlled trial in stage-2 hypertensive patients. Complement Ther Med. 2018 Aug;39:43-48. doi: 10.1016/j.ctim.2018.05.014. Epub 2018 May 26.

• Responsible Party: Praew Kotruchin, Principal investigator, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT03381820
• Other Study ID Numbers: HE581320
• First Posted: December 22, 2017
• Last Update Posted: December 22, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data is available when contact and request to the correspondence author or principal investigator.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Praew Kotruchin, Khon Kaen University:

music therapy; hypertension; Asian; stage-2 hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases