Indian Instrumental Music in Hypertension

NCT02147366 | Completed DMC

• 1 other identifier: 2010-13440
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• Hypertension is one of the leading risk factors influencing morbidity and mortality. There is need for non-pharmacological management for the same. Music is known to reduce anxiety and holds promise for non-pharmacological management of hypertension owing to low cost, ease of administration and safety. The efficacy of music to reduce blood pressure (BP) has not been established. Besides inconsistent findings, earlier studies using music are frequently inconclusive from small sample size. The studies have not examined the biomarkers of hypertension.
• The purpose of this study was to evaluate the effect of Indian Instrumental music on pre-hypertensives and stage 1 hypertensives subjects. Non-pharmacological intervention improves the quality of life of hypertensives and music may serve as an adjunct therapy along with standard management of hypertensives.

Conditions

Hypertension

Keywords

Hypertension,ambulatory pressure,autonomic function,music

Outcome Measures

Primary Outcomes (1)

• 24 hour Blood Pressure

  Blood Pressure in mm of Hg - Overall, awake and asleep

  3 months

Secondary Outcomes (2)

• Biomarkers of hypertension

  3 months

• Autonomic function

  3 months

Study Arms (2)

Behavioral (Lifestyle)

EXPERIMENTAL

Only standard lifestyle modifications The prehypertensives and stage I hypertensives will be randomized to receive each of the two three experimental conditions: music along with standard lifestyle modifications or only standard lifestyle modifications in random order over the course of three months.

Behavioral: Lifestyle

Behavioral (Music & lifestyle changes)

EXPERIMENTAL

Experimental: Music along with standard lifestyle modifications The prehypertensives and stage I hypertensives will be randomized to receive each of the two three experimental conditions: music along with standard lifestyle modifications or only standard lifestyle modifications in random order over the course of three months.

Behavioral: Music & lifestyle changes

Interventions

Music & lifestyle changes BEHAVIORAL

Music intervention involved listening to raga bhimpalas played on bansuri/flute (an Indian instrument) for 15 minutes daily for 3 months.

Behavioral (Music & lifestyle changes)

Lifestyle BEHAVIORAL

Lifestyle intervention was based on Joint national committee VII guidelines for hypertension

Behavioral (Lifestyle)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age group of 30 to 60 years. Prehypertensives and stage I hypertensives were identified as per Joint National Committee (JNC) VII classification

You may not qualify if:

• Pregnant women, subjects with body mass index (BMI) ≥35 kg/m2, stage 2 Hypertension (HTN), renal impairment, uncontrolled diabetes, raised intracranial tension, stroke, epilepsy, hearing problems, psychiatric disorder, other cardiovascular and respiratory disorders, or any other illness which is known to affect the BP status of the individual were excluded from the study.

Sponsors & Collaborators

• MS Ramaiah Medical College & Hospitals: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

M S Ramaiah Medical college and hospitals

Bangalore, Karnataka, 560054, India

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• KIRTHANA U KUNIKULLAYA, MD, DNB

  M S Ramaiah Medical college and hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kirthana Kunikullaya U, Assistant Professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

IN (1)