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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Music & lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour Blood Pressure
Blood Pressure in mm of Hg - Overall, awake and asleep
Measured: 3 months
Secondary outcomes (2)
Biomarkers of hypertension
Plasma catecholamines, renin, endothelin and superoxide dismutase
Measured: 3 months
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.
- First posted26 May 2014 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- MS Ramaiah Medical College & Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, KIRTHANA KUNIKULLAYA U, MS Ramaiah Medical College & Hospitals
- Investigators
- KIRTHANA U KUNIKULLAYA, MD, DNB, Principal investigator, M S Ramaiah Medical college and hospitals
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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Music in Non Pharmacological Management of Hypertension
- ClinicalTrials.gov ID
- NCT02147366
- Acronym / sponsor ID
- MIH / 2010-13440
- Conditions
- Hypertension
- Keywords
- Hypertension,ambulatory pressure,autonomic function,music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MS Ramaiah Medical College & HospitalsUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral (Lifestyle) | Experimental | Behavioral: LifestyleOnly 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) | Experimental | Behavioral: Music & lifestyle changesExperimental: 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age group of 30 to 60 years. Prehypertensives and stage I hypertensives were identified as per Joint National Committee (JNC) VII classification
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music & lifestyle changesMusic intervention involved listening to raga bhimpalas played on bansuri/flute (an Indian instrument) for 15 minutes daily for 3 months. | Behavioural | Behavioral (Music & lifestyle changes) |
| LifestyleLifestyle intervention was based on Joint national committee VII guidelines for hypertension | Behavioural | Behavioral (Lifestyle) |
Primary outcome
24 hour Blood Pressure
Time frame: 3 months
Blood Pressure in mm of Hg - Overall, awake and asleep
2 secondary outcomes
Biomarkers of hypertension
Time frame: 3 months
Autonomic function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KIRTHANA U KUNIKULLAYA, MD, DNB principal investigator
M S Ramaiah Medical college and hospitals
1 site in 1 country: see every site and its status.
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.