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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2007/013
Date of registration: 19/10/2007
Primary sponsor: None
Public title: 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]
Scientific title: 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
Date of first enrolment: 2/1/2007
Target sample size: Study 1 - 532 subjects Study 2 - 66 subjects
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={EEFA0653-958A-49A6-980E-686140A4E776}
Study type:  Interventional
Study design:  Study 1 Community based experimental study Study 2 Randomised controlled trial (Clinical trial)  
Countries of recruitment
Sri Lanka
Contacts
Name: Dr. T.L.S.S.Siritunga 
Address:  56/1, Morontuduwa Road, Wadduwa
Telephone: 038-2233072 , 077-9664127
Email: sssiritunga@yahoo.com
Affiliation:  Medical Officer (Trainee - MD Community Medicine)
Name: Dr. T.L.S.S.Siritunga 
Address:  56/1, Morontuduwa Road, Wadduwa
Telephone: 038-2233072, 077-9664127
Email: sssiritunga@yahoo.com
Affiliation:  Medical Officer (Trainee - MD Community Medicine)
Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Cardio respiratory physiology and chronic stable angina
Intervention(s)
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
Primary Outcome(s)
Study 1 Changes in Diastolic Blood pressure Study 2 The time taken to 1 mm ST segment depression in exercise ECG
Secondary Outcome(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
Secondary ID(s)
None
Source(s) of Monetary Support
Not yet found
Secondary Sponsor(s)
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