CTRI Number |
CTRI/2018/03/012404 [Registered on: 07/03/2018] Trial Registered Retrospectively |
Last Modified On: |
15/11/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
the ability of a animation distraction to decrease pain in children undergoing cannulation |
Scientific Title of Study
|
The efficacy of an animation distraction for pain relief in young children undergoing cannulation in a rural teaching hospital: a randomised controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
BIJIS |
Designation |
MEDICAL STUDENT |
Affiliation |
MOSC Medical college |
Address |
2013 Batch
MOSC Medical College Kolenchery
Ernakulam District
Ernakulam KERALA 682311 India |
Phone |
9496961012 |
Fax |
4842760409 |
Email |
bijispattazhy@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anna Mathew |
Designation |
Professor Research Coordinator |
Affiliation |
MOSC Medical College |
Address |
Department of pharmacology
MOSC medical college
Kolenchery
Ernakulam
kerala
Ernakulam KERALA 682311 India |
Phone |
9442221950 |
Fax |
4842760409 |
Email |
mosc.research@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anna Mathew |
Designation |
Professor Research Coordinator |
Affiliation |
MOSC Medical College |
Address |
Department of pharmacology
MOSC medical college
Kolenchery
Ernakulam
kerala
Ernakulam KERALA 682311 India |
Phone |
9442221950 |
Fax |
4842760409 |
Email |
mosc.research@gmail.com |
|
Source of Monetary or Material Support
|
ICMR
Ansari Nagar
New Delhi,
Delhi 110029
STS ID NO 2016-00198
|
|
Primary Sponsor
|
Name |
MOSC Medical College |
Address |
MOSC medical college
kolenchery
Ernakulam district
kerala pin 682311 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
BijiS |
MOSC medical college |
Pediatric ward
MOSC Medical college
kolenchery
Ernakulam kerala
pin 682311 Ernakulam KERALA |
9496961012 4842760409 bijispattazhy@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MOSC Medical College Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
3 to8 year old children admitted in pediatric ward, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group A |
Nature animation distraction to children undergoing cannulation |
Comparator Agent |
Group B |
Blank screen (with out distraction)shown to children |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
Children in the age group 3-8 years whose parents give the informed consent who have venous cannulation in first or second prick who have not received paracetamol in last two hours |
|
ExclusionCriteria |
Details |
children need more than two pricks. Children who have auditory and visual impairment or cerebral palsy. Children who are mentally challenged |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
children in the interventional group who receive animation distraction are likely to have lower pain score on the FACES pain Scale |
2 month |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="64" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
19/04/2016 |
Date of Study Completion (India) |
16/06/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
BJBMR |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
BACKGROUND: Children undergoing invasive medical procedures experience pain, anxiety and stress. Experiences with painful needle procedures in childhood may lead to long-term negative attitudes toward clinicians, hospitals and the utilization of health care services1. Distraction has been shown to be an effective method of reducing pain as they can divert attention away from the painful stimuli2. Given the importance of pain relief in the child, it is important to establish the most reliable, safe and low-cost intervention in this rural teaching hospital. OBJECTIVES: To assess the effectiveness of an animation distraction in alleviating pain measured using the Wong Baker FACES pain-rating scale in children undergoing venous cannulation in the paediatric ward of a rural teaching hospital. METHODOLOGY: This parallel group, single blinded, randomised controlled trial undertaken in children between 3 to 8 years of age, undergoing venous cannulation. A total of 64 children were randomised into two groups by permuted block randomisation with allocation concealment. A nature animation was shown to children in the intervention group. Pain was assessed by Wong Baker FACES pain-rating scale at pre-cannulation, during and one and three minutes post-cannulation. The mean pain scores in the two groups were compared using the student t-test. RESULTS: The demographic variables in the two groups tested for homogeneity by Chi square test. The result revealed that there is significantly (p<0.005) less pain in children with animation distraction at initiation, at one minute, at three minute cannulation. At zero minute (during pricking) the difference of mean score of both groups is 1.313 and p=0.015(p<0.05).At one minute (after pricking) the difference in mean score was 1.938 and p=0.002.At third minute of pricking the difference in mean score was 3.125 and p=0.000(p<0.05).The result showed the statistical significant difference of mean pain score at 0, 1,3 minute. CONCLUSION: If the pain score of children on the FACES scale is reduced in the intervention group it will show that animation distraction provides effective pain relief. This is a simple, cost-effective and easily implementable measure to reduce pain.
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