Condition category
Circulatory System
Date applied
06/11/2019
Date assigned
07/11/2019
Last edited
07/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Elsa Mathew
elsamathewchettoor@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Ms Elsa Mathew

ORCID ID

http://orcid.org/0000-0001-9954-0637

Contact details

Little Flower Medical Research Centre
Angamaly
Ernakulam
683572
India
+91 484 2675000
elsamathewchettoor@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The therapeutic effect of music on selected physiological and biochemical parameters in hypertension

Acronym

TEMSPBPH

Study hypothesis

There will be a significant difference in the selected physiological and biochemical parameters in hypertension after music therapy

Ethics approval

Approved 08/06/18, Institutional ethics committee of Little Flower Hospital and Research Centre, (Angamaly, Kerala, India; +91 484 2452546; admin@lfhospital.org), ref: IEC/LFMRC/18/1

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

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

Intervention type

Other

Phase

Drug names

Primary outcome measure

Blood pressure measured at baseline and three months

Secondary outcome measures

At baseline and three months:
1. Anthropometry:
1.1. Waist to Hip Ratio (cm)
1.2. Body Mass Index (BMI) (kg/m²)
2. Physiological variables:
2.1. Heart rate (bpm)
2.2. SPO2
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

01/01/2017

Overall trial end date

09/06/2019

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

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

09/06/2018

Recruitment end date

09/03/2019

Locations

Countries of recruitment

India

Trial participating centre

Little Flower Hospital and Research Centre
Kerala
Angamaly
683572
India

Sponsor information

Organisation

Little Flower Hospital and Research Centre

Sponsor details

-
Angamaly
683572
India
+91 (0)484 2458327
lfmrcang@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.lfhospital.org

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

12/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/11/2019: Trial’s existence confirmed by Institutional ethics committee of Little Flower Hospital and Research Centre