Home » Trials » SLCTR/2014/031
A study on the effect of music and visual distraction in addition to sedation on pain perception and patient corporation compared to sedation alone in patients undergoing colonoscopy
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SLCTR Registration Number
SLCTR/2014/031
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A study on the effect of music and visual distraction in addition to sedation on pain perception and patient corporation compared to sedation alone in patients undergoing colonoscopy
Public Title of Trial
Effect of music and visual distraction on patients undergoing colonoscopy
Disease or Health Condition(s) Studied
Pain perception during colonoscopy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P141/08/2012 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is audio-visual distraction in addition to sedation an effective means of reducing pain perception, dose of analgesics and sedatives and improving corporation of patients when undergoing colonoscopy compared to sedation with music or sedation alone?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Consenting participants meeting inclusion/exclusion criteria will be randomized to three arms. All arms will receive midazolam (stating dose of 1mg and increments of 0.5mg) and pethidine (5mg initial dose followed by 5mg increments) until adequate analgesia is achieved by the patient.
Arm 1 will receive audio distraction (a song of their preference) through ear phones.
Arm 2 will receive audio-visual distraction (a movie of their preference) using eye trek system (SONY head mounted display- HMZ-T3W) with the ear phones.
Arm 3 will receive sedation and pain relief alone.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At the end of the procedure once fully recovered from sedation ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
228
Countries of recruitment
Sri Lanka
Anticipated start date
2014-11-24
Anticipated end date
2015-10-30
Date of first enrollment
Date of study completion
Recruitment status
Terminated
Funding source
Approved by the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya on 15.08.2012 (Ref P141/08/2012)
Regulatory approvals
Status
Approved
Date of Approval
2012-08-15
Approval number
P141/08/2012
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Arjuna De Silva
Consultant Physician
Department of Medicine,
Faculty of Medicine,
University of Kelaniya,
PO Box: 6
Thalagolla Road,
Ragama.
Tel: 0112961119
Mob: 0777572379
apdsilva@yahoo.com
Contact Person for Public Queries
Arjuna De Silva
Consultant Physician
Department of Medicine,
Faculty of Medicine,
University of Kelaniya,
PO Box: 6
Thalagolla Road,
Ragama.
Tel: 0112961119
Mob: 0777572379
apdsilva@yahoo.com
Primary study sponsor/organization
Department of Medicine
Faculty of Medicine,
PO Box: 6 Thalagolla Road, Ragama.
Tel: 0112961119
http://www.kln.ac.lk/medicine/index. php/departments/medicine
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
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
