SLCTR Registration Number
Date of Registration
The date of last modification
Jun 30, 2017
View original TRDS
Scientific Title of Trial
Randomized clinical trial on effectiveness of tranquilizing classical music in pain, mood and anxiety modulation in terminally ill / cancer patients
Public Title of Trial
Effect of classical music in pain, mood and anxiety in terminally ill / cancer patients
Disease of Health Condition(s) Studied
Pain in terminally ill / cancer patients
Effectiveness of music in pain, mood and anxiety in cancer patients
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
ERC (SJP) 44/15
What is the research question being addressed?
What is the effect of tranquillizing classical music in the modulation of pain, mood and anxiety in terminally ill/cancer patients?
Type of study
Randomized controlled trial
Masking not used
The study will be carried out in wards of Cancer Institute Maharagama and Hospice Maharagama
Consenting participants meeting inclusion/exclusion criteria will be allocated by drawing of lots into intervention and control arms.
The study will be carried out avoiding visiting hours and meal times.
Arm A: It will be ensured that there will be no distracting loud noises and other stimuli (e.g. television) in the study setting for the study duration. Participants will be asked to lie down in bed for 15 minutes. The basal vitals (heart rate, blood pressure and pupillary size under moderate light / day light), the pain score (on a visual analogue scale with a 0-10 point range) and the level of anxiety and or depression (subjectively – on a visual analogue scale) will be noted at the end of resting time. Then, tranquilizing instrumental classical music (eastern and/or western) on a cheerful note will be played while the patients continue to rest for a duration of 30 minutes.
Arm B: Participants will be asked to lie down in bed for 30 minutes. The basal vitals (heart rate, blood pressure and pupillary size under moderate light / day light), the pain score and the level of anxiety and or depression will be noted as above at the end of resting time. Then, they will continue to rest in the usual environment for a further 30 minutes. The vitals, pain and anxiety scores will be reassessed immediately afterwards.
The following day, the participants will be subjected to a crossover, with Arm B receiving the intervention and Arm A the control.
Patients with diagnosed mental illness/retardation/handicap
Primary outcome(s) - Time of assessment(s)
At baseline and immediately after the intervention (30 minutes of rest time), and at 4, 8, 12 and 24 hours from the completion of the intervention
Secondary outcome(s) - Time of assessment(s)
At the baseline resting time, and immediately after the 30 minutes intervention/rest time
Target number/sample size
140 (70 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayewardenepura on 6.2.2016 (Ref. 44/15)
Contact person for Scientific Queries/Principal Investigator
Dr. G.V.M. Chamath Fernando
Dr. G.V.M. Chamath Fernando, Department of Family Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura
+94 11 2758786
Contact Person for Public Queries
Dr. Lagath Udara Wanigabadu (Co-investigator)
Dr. Lagath Udara Wanigabadu, Intensive Care Unit, Base Hospital - Horana
Primary study sponsor/organization
Dr Buddhika Vidanagama
Consultant Anaesthetist and Supervisor
National Cancer Institute, Maharagama Sri Lanka
Tel: 011 2 850252/ Mob: 077344 3024