Home » Trials » SLCTR/2019/027
A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions
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SLCTR Registration Number
SLCTR/2019/027
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
A non-randomized controlled before and after study to determine the effectiveness of an Illustrated Information Leaflet (IIL) on maternal practice of administering paediatric antibacterial suspensions
Public Title of Trial
A non randomized controlled trial to determine the effectiveness of an illustrated information leaflet on teacher mothers’ practices on administering paediatric antibacterial suspensions
Disease or Health Condition(s) Studied
Administration of antibacterial suspension
Scientific Acronym
None
Public Acronym
None
Brief title
An intervention to improve the administering practices of antibacterial suspension by mothers
Universal Trial Number
U1111-1234-2595
Any other number(s) assigned to the trial and issuing authority
EC-18-006 ,ERC ,Faculty of Medicine ,UOC
What is the research question being addressed?
Can an illustrated information leaflet reduce the errors made by teacher mothers when administering paediatric antibacterial suspensions?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded : Investigators
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
An initial descriptive study was done on teacher mothers to determine the prevalence of proper and improper practice when administering paediatric antibacteric suspensions using a scorecard. For the intervention study participants from different education zones in the Jaffna district will be selected. A block randomization procedure will be done to have the proportion of correct practice: incorrect practice teachers across the two arms. The final illustrated information leaflet (IIL) was translated into Tamil and was pretested This IIL conveys information on reconstitution techniques, measuring devices, and administration and storing instructions. The leaflet will be given by principal investigator just before collecting the data. Time will be given to read and understand the leaflet. Any queries will be clarified before collecting data
Inclusion criteria
1.Female teachers below 60 years 2. Have at least one child under the age of 6
Exclusion criteria
Primary outcome(s)
|
1.
1.Proportion of mothers with administration errors when administering oral antibacterial suspension. This will be assessed using a scorecard which was developed by the experts during the descriptive study. There are 21 steps each carrying either 1 or 0 marks |
[ Soon after the intervention and 3 months after the intervention ] |
Secondary outcome(s)
|
1.
1.Acceptability of the intervention by the participants using a questionnaire. 8 questions will be marked by the mothers on a Liket scale of 1-5 If all the questions get overall panel median score of > 3 it is considered as acceptable. |
[ After 3 months of the intervention ] |
Target number/sample size
20 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2019-08-08
Anticipated end date
2019-11-08
Date of first enrollment
2019-08-27
Date of study completion
Recruitment status
Recruiting
Funding source
self funded
Regulatory approvals
Status
Approved
Date of Approval
2018-02-15
Approval number
EC-18-006
Details of Ethics Review Committee
| Name: | Ethics Review committee,Faculty of Medicine,University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800, Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Abarna Nadeshkumar
Lecturer
Department of Pharmacy and Pharmaceutical Sciences
Faculty of Allied Health Sciences
University of Sri Jayewardenepura
Nugegoda
+94777568799
abi0108@yahoo.com
Contact Person for Public Queries
Professor Shalini Sri Ranganathan
Head
Department of Pharmacology
Faculty of Medicine
University of Colombo
+94 (0) 112695300 ext 198
sshalini14@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
