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Indian Instrumental Music in Hypertension (MIH)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Music & lifestyle changes
Lifestyle
Sponsored by
MS Ramaiah Medical College & Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Hypertension,ambulatory pressure,autonomic function,music

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • M S Ramaiah Medical college and hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Behavioral (Lifestyle)

Behavioral (Music & lifestyle changes)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biomarkers of hypertension
Plasma catecholamines, renin, endothelin and superoxide dismutase
Autonomic function
Heart rate variability parameters (Time domain and frequency domain)

Full Information

First Posted
May 22, 2014
Last Updated
May 24, 2014
Sponsor
MS Ramaiah Medical College & Hospitals
Collaborators
Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02147366
Brief Title
Indian Instrumental Music in Hypertension
Acronym
MIH
Official Title
Role of Music in Non Pharmacological Management of Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MS Ramaiah Medical College & Hospitals
Collaborators
Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Arterial hypertension is an important risk factor for diseases like myocardial infarction and stroke leading to increased morbidity and mortality. Lifestyle modifications are often recommended as a part of treatment for mild hypertension, but the efficacy of the adjunct therapy is unclear. Weight loss and salt restriction are the most effective modalities, but each requires a major change in dietary habits, which is difficult for patient compliance. A number of therapeutic modalities that aim to reduce stress and encourage relaxation have been evaluated for the treatment of hypertension. Various methods like autogenic training, cognitive therapy, behavioral therapy, Meditation, Guided imagery, biofeedback, progressive muscle relaxation, breathing exercises, yoga have been previously studied to reduce hypertension. Music has long been known to reduce anxiety, minimize the need for sedatives, and make patients feel more at ease. Music therapy is different from music medicine. Music therapists individualize their interventions according to patient's needs. Patients actively get engaged in music making. However, in music medicine, subject listens to pre-recorded music with perceived benefit. A number of research studies have been conducted to determine the effects of music on a variety of clinical conditions. Effect of music on stress reduction has been documented in physiological (e.g. heart rate, blood pressure), neurological (e.g. EEG readings) and psychological domains. In addition, the effect of music intervention has been documented in a range of medical, surgical, oncology, and pediatric patients. In one of the studies on hypertensive individuals, there was a significant decrease in both systolic (15.9 mm Hg reduction) and diastolic BP (9 mm Hg) after weekly music therapy sessions for duration of 12 weeks. The control group did not show significant changes (Márquez-Celedonio, 2009). Among hypertensives, there was a significant reduction in BP after using a device which guides the user towards slow and regular breathing using musical sound patterns. The device was used for 10 minutes daily at home for 8 weeks. The control group in this study were given a walkman with which patients listened to quiet music. Treatment with the device reduced systolic BP, diastolic BP and Mean arterial pressure (MAP) by 15.2,10.0 and 11.7 mm Hg respectively, as compared to 11.3, 5.6 and 7.5 mm Hg with the Walkman (Schein, 2001). Another study evaluated the short and long-term effects of audio relaxation programs for BP reduction in older adults. The subjects listened to a 12-minute audio relaxation program. The reduction in systolic and diastolic BP was statistically and clinically significant (Tang, 1996). There are very few studies that have examined the effect of music on hormone levels that are of particular relevance to heart disease, including adrenaline and noradrenaline concentrations levels and other stress hormones that can be deleterious to cardiac functioning. Further, to the best of our knowledge, there are no studies done among prehypertensives using music as the intervention. Thus we propose to study whether blood pressure among prehypertensives and stage 1 hypertensives can decrease after music intervention. In order to know the mechanism underlying this reduction, we propose to study the biomarkers (indicating the function of vascular endothelium, stress hormones, oxidative stress) responsible in the causation of hypertension and autonomic function. A better understanding of alterations in these biomarkers will help us to explain the mechanism of action and validate music intervention as a tool in non-pharmacological management of hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension,ambulatory pressure,autonomic function,music

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral (Lifestyle)
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral (Music & lifestyle changes)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music & lifestyle changes
Intervention Description
Music intervention involved listening to raga bhimpalas played on bansuri/flute (an Indian instrument) for 15 minutes daily for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Intervention Description
Lifestyle intervention was based on Joint national committee VII guidelines for hypertension
Primary Outcome Measure Information:
Title
24 hour Blood Pressure
Description
Blood Pressure in mm of Hg - Overall, awake and asleep
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Biomarkers of hypertension
Description
Plasma catecholamines, renin, endothelin and superoxide dismutase
Time Frame
3 months
Title
Autonomic function
Description
Heart rate variability parameters (Time domain and frequency domain)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age group of 30 to 60 years. Prehypertensives and stage I hypertensives were identified as per Joint National Committee (JNC) VII classification Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KIRTHANA U KUNIKULLAYA, MD, DNB
Organizational Affiliation
M S Ramaiah Medical college and hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
M S Ramaiah Medical college and hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India

12. IPD Sharing Statement

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Indian Instrumental Music in Hypertension

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