Home » Trials » SLCTR/2007/013
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
The date of last modification
Mar 03, 2019
Trial Status
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 or Health Condition(s) Studied
Cardio respiratory physiology and chronic stable angina
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial 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)
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
Parallel
Purpose
Other
Study Phase
Not Applicable
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)
|
1.
Study 1 Changes in Diastolic Blood pressure Study 2 The time taken to 1 mm ST segment depression in exercise ECG |
[ at 20 minutes ] |
Secondary outcome(s)
|
1.
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 |
[ after 1 month ] |
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
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2007-01-17
Approval number
330/7
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
