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SLCTR Registration Number
SLCTR/2016/006
Date of Registration
The date of last modification
Sep 28, 2016
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 or Health Condition(s) Studied
Pain in terminally ill / cancer patients
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of music in pain, mood and anxiety in cancer patients
Universal Trial Number
U1111-1175-9732
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
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy
Assignment
Crossover
Purpose
Supportive care
Study Phase
Intervention(s) planned
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.
Inclusion criteria
Exclusion criteria
Patients with diagnosed mental illness/retardation/handicap
Primary outcome(s)
|
1.
|
[ At baseline and immediately after the intervention (30 minutes of rest time) ] |
|
2.
Mood score on a 10 point visual analogue scale |
[ 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 ] |
|
3.
Anxiety using a 10 point visual analogue scale |
[ 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)
|
1.
|
[ At the baseline resting time, and immediately after the 30 minutes intervention/rest time ] |
|
2.
Blood pressure |
[ At the baseline resting time, and immediately after the 30 minutes intervention/rest time ] |
|
3.
Pupillary size under moderate light / day light |
[ 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
Sri Lanka
Anticipated start date
2016-03-01
Anticipated end date
2016-04-30
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr. G.V.M. Chamath Fernando
Lecturer (Probationary)
Dr. G.V.M. Chamath Fernando,
Department of Family Medicine,
Faculty of Medical Sciences,
University of Sri Jayewardenepura
+94 11 2758786
+9476609192
chemetf@gmail.com
Contact Person for Public Queries
Dr. Lagath Udara Wanigabadu (Co-investigator)
Medical Officer
Dr. Lagath Udara Wanigabadu,
Intensive Care Unit,
Base Hospital - Horana
+94342261261
+94772264232
lagathurc@yahoo.com
Primary study sponsor/organization
Dr Buddhika Vidanagama
Consultant Anaesthetist and Supervisor
National Cancer Institute, Maharagama
Sri Lanka
Tel: 011 2 850252/ Mob: 077344 3024
buddhikav@yahoo.co.uk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
