Plain English Summary
Background and study aims
Cardiovascular disease is one of the leading causes of mortality and morbidity in India and worldwide. The global prevalence of hypertension was estimated to be 1.3 billion in 2015. It is related to nearly 17 million deaths per year worldwide. Hypertension is amenable to a minimum of 45% of deaths due to heart disease and 51% of deaths due to stroke. WHO called hypertension a silent killer. There is increasing evidence suggests that psychological factors may play an important role in the development of hypertension. Stress, depression and emotional personality traits like trait anxiety and trait anger are also connected with other cardiovascular disorders, especially with coronary heart disease. Music has a wide application with each stage of the development of human life. Music therapy is a novel approach for the management and control of anxiety and hypertension. The study aims to evaluate the effect of music therapy on blood pressure, physiological and biochemical parameters in hypertensive patients
Who can participate?
Patients with high blood pressure aged 25 - 65 years
What does the study involve?
Music therapy was given as a physiological intervention. The instrumental music of Ananda Bhairavi Raga was used for 30 minutes per day for three months. The modifications in blood pressure, anxiety level, and oxidative stress markers were evaluated before and after music therapy.
What are the possible benefits and risks of participating?
Music therapy may reduce blood pressure, anxiety, and oxidative stress. Since music therapy is a noninvasive intervention, there is no risk of participation in the study.
Where is the study run from?
Little Flower Hospital and Research Centre, India
When is the study starting and how long is it expected to run for?
June 2018 to June 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
The therapeutic effect of music on selected physiological and biochemical parameters in hypertension
There will be a significant difference in the selected physiological and biochemical parameters in hypertension after music therapy
Approved 08/06/18, Institutional ethics committee of Little Flower Hospital and Research Centre, (Angamaly, Kerala, India; +91 484 2452546; email@example.com), ref: IEC/LFMRC/18/1
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Subjects were randomly divided into the experimental and control groups by block randomization with equal numbers of subjects in each group. Instrumental music of Ananda Bhairavi raga was provided to the experimental group 30 minutes per day for three months. The physiological and biochemical parameters were measured for all the participants before the beginning of the study and after three months
Primary outcome measure
Blood pressure measured at baseline and three months
Secondary outcome measures
At baseline and three months:
1.1. Waist to Hip Ratio (cm)
1.2. Body Mass Index (BMI) (kg/m²)
2. Physiological variables:
2.1. Heart rate (bpm)
3. Anxiety level measured using the stress assessment questionnaire - STAI (State Trait Anxiety Inventory)
4. Lipid profile (blood test):
4.1. Total Cholesterol (TC)
4.2. High Density Lipoprotein (HDL)
4.3. Low Density Lipoprotein (LDL)
4.4. Very Low Density Lipoprotein (VLDL)
4.5. Triglycerides (TG)
5. Oxidative stress markers (blood test):
5.1. Malondialdehyde level (MDA) (spectrophotometric method)
5.2. Superoxide dismutase (SOD) (spectrophotometric method)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Express a willingness to participate in the study
2. Age between 25 - 65 years
3. DBP >80mm Hg and SBP >130mm Hg
Target number of participants
Participant exclusion criteria
1. Deafness, ear surgeries, and ear infections
2. Ear implants and hearing aids
3. Terminally ill patients
4. Planned surgery during the course of the study
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Little Flower Hospital and Research Centre
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
Participant level data
Basic results (scientific)