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HypertensionMIHNCT02147366

Indian Instrumental Music in Hypertension

A study testing Music & lifestyle changes and Lifestyle in people with Hypertension, run by MS Ramaiah Medical College & Hospitals at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Music & lifestyle changes and Lifestyle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndia
Study dates
May 2012to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site
  • M S Ramaiah Medical college and hospitals

    Bangalore, Karnataka, 560054

Other trials in India

About this study

Official title: Role of Music in Non Pharmacological Management of Hypertension

  • 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.
Read the 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.

Conditions
Hypertension
Being tested
Music & lifestyle changes, Lifestyle
Keywords
Hypertension,ambulatory pressure,autonomic function,music
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music & lifestyle changesBehavioural

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

  • LifestyleBehavioural

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

Study groups in NCT02147366
Study groupRoleWhat they receive
Behavioral (Lifestyle)ExperimentalOnly 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.
Receives: Behavioral: Lifestyle
Behavioral (Music & lifestyle changes)ExperimentalExperimental: 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.
Receives: Behavioral: Music & lifestyle changes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24 hour Blood Pressure

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

    Measured: 3 months

Secondary outcomes (2)
  1. Biomarkers of hypertension

    Plasma catecholamines, renin, endothelin and superoxide dismutase

    Measured: 3 months

  2. Autonomic function

    Heart rate variability parameters (Time domain and frequency domain)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2014 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02147366
Sponsor's protocol ID
2010-13440
Acronym
MIH
Status last verified
May 2014
First submitted
22 May 2014
Last updated
28 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Music & lifestyle changes and Lifestyle in people with Hypertension, run by MS Ramaiah Medical College & Hospitals at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24 hour Blood Pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.

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