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Randomized clinical trial on effectiveness of tranquilizing classical music in pain, mood and anxiety modulation in terminally ill / cancer patients

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SLCTR Registration Number

SLCTR/2016/006


Date of Registration

01 Mar 2016

The date of last modification

Jan 29, 2019


View original TRDS


Trial Status



Application Summary


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


Trial Details


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/practice


Assignment

Crossover


Purpose

Supportive care


Study Phase

Not Applicable


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

  1. Adult (>12 years of age) in-ward and hospice patients
  2. Baseline pain (with or without regular analgesic therapy) Baseline pain is determined by patients who complain of a pain. It is subjective measurement. It will not be assessed objectively since its patients’ perception.
  3. Patients with GCS 15/15

Exclusion criteria

Patients with diagnosed mental illness/retardation/handicap



Primary outcome(s)

  1. Pain 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

    ]
  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. Heart rate

    [

    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

2016-08-12


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

None


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2016-02-06


Approval number

44/15


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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