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The effect of music: on selected aspects of cardio respiratory physiology of asymptomatic individuals and on selected aspects of the clinical profile and the quality of life of chronic stable angina patients -

SLCTR Registration Number

SLCTR/2007/013


Date of Registration

19 Oct 2007

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


Scientific Title of Trial

The effect of music: on selected aspects of cardio respiratory physiology of asymptomatic individuals and on selected aspects of the clinical profile and the quality of life of chronic stable angina patients


Public Title of Trial

The effect of music: on cardio respiratory physiology of asymptomatic individuals and the effect of music on the disease condition and the quality of life in patients heart disease [stable angina patients]


Disease of Health Condition(s) Studied

Cardio respiratory physiology and chronic stable angina


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

330/7 (Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardenepura)


Trial Details


What is the research question being addressed?

The effect of music on human physiology ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment


Purpose


Intervention(s) planned

Study 1 Community based experimental study Study 2 Randomised controlled trial (Clinical trial). Listening to a piece of music for 20 minutes Study 2 Listening to a piece of music twice a day for 20 minutes each for one month


Inclusion criteria

Study 1 Both male and female individuals between 45 to 65 years of age The individuals who are not having heart disease and hypertension and who are not being on any long term treatment The individuals whose pulse rate, blood pressure and heart sounds are within normal range The individuals who don’t have hearing impairment Study 2 Clinically diagnosed chronic stable angina patients confirmed by exercise ECG using bruce protocol during the study period Patients with no other heart diseases Both male and female patients between 45 to 65 years of age Patients whose clinical condition is stable and who do not require frequent change of the treatment Patients who can perform exercise ECG test Patients who like to participate in the study


Exclusion criteria

Study 1 •Both male and female individuals less than 45 years of age and more than 65 years of age •Individuals who are being on long-term treatment for any disease •The individuals whose pulse rate, blood pressure and heart sounds are not within normal range •The individuals who have hearing impairment Study2 •Previously diagnosed patients with chronic stable angina •Clinically diagnosed chronic stable angina patients •confirmed by exercise ECG using Modified Bruce protocol during the study period •Patients with other heart diseases •Patients with heart failure •Patients who are being on treatment for Hypertension and Diabetes Mellitus •Patients who are less than 45 years of age and more than 65 years of age •Patients whose clinical condition is not stable and who change their treatment frequently •Patients who cannot perform exercise ECG such as disabled patients •Patients who do not like to participate in the study



Primary outcome(s)

Study 1 Changes in Diastolic Blood pressure Study 2 The time taken to 1 mm ST segment depression in exercise ECG


Primary outcome(s) - Time of assessment(s)

at 20 minutes


Secondary outcome

Study 1 •Blood pressure •Pulse rate •Respiratory rate Study 2 •Clinical Profile: State of Ischemia •Exercise duration (s) •Stage at which patient stops the test •Maximal heart rate during exercise (beats. Min-1) •Time until 1 mm ST segment depression •Maximal ST segment depression •Double product (Heart rate/min X Blood pressure mmHg) •Symptom of ischemia •Quality of life


Secondary outcome(s) - Time of assessment(s)

Study 1 •Blood pressure •Pulse rate •Respiratory rate Study 2 •Clinical Profile: State of Ischemia •Exercise duration (s) •Stage at which patient stops the test •Maximal heart rate during exercise (beats. Min-1) •Time until 1 mm ST segment depression •Maximal ST segment depression •Double product (Heart rate/min X Blood pressure mmHg) •Symptom of ischemia •Quality of life



Target number/sample size

Study 1 - 532 subjects Study 2 - 66 subjects


Countries of recruitment

Sri Lanka


Anticipated start date

2007-01-02


Anticipated end date

2007-12-31


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardenepura (330/7)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. T.L.S.S.Siritunga
Dr. T.L.S.S.Siritunga
56/1, Morontuduwa Road, Wadduwa
038-2233072
077-9664127

sssiritunga@yahoo.com

Contact Person for Public Queries

Dr. T.L.S.S.Siritunga
Dr. T.L.S.S.Siritunga
56/1, Morontuduwa Road, Wadduwa
038-2233072
077-9664127

sssiritunga@yahoo.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None