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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
no  no 
 
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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