Indian Instrumental Music in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Intervention name(s): Music & lifestyle changes; Lifestyle
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Music intervention involved listening to raga bhimpalas played on bansuri/flute (an Indian instrument) for 15 minutes daily for 3 months.; Lifestyle intervention was based on Joint national committee VII guidelines for hypertension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypertension,ambulatory pressure,autonomic function,music