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CTRI Number  CTRI/2016/12/007561 [Registered on: 09/12/2016] Trial Registered Retrospectively
Last Modified On: 08/11/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized controlled trial to assess the effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh 2014-16.  
Scientific Title of Study   A randomized controlled trial to assess the effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh 2014-16.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LARISHISHA RISAW 
Designation  MSC Nursing  
Affiliation  National Institute Of Nursing Education, PGIMER, Chandigarh 
Address  National Institute Of Nursing Education, PGIMER, Chandigarh
National Institute Of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9855670746  
Fax    
Email  l.risaw88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Kavita Narang 
Designation  Lecturer 
Affiliation  NINE,PGIMER,Chandigarh 
Address  NINE,PGIMER,Chandigarh
NINE,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9872839990  
Fax    
Email  gaurikavita@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  LARISHISHA RISAW 
Designation  MSC Nursing student 
Affiliation  National Institute Of Nursing Education, PGIMER, Chandigarh 
Address  National Institute Of Nursing Education, PGIMER, Chandigarh
National Institute Of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9855670746  
Fax    
Email  l.riisaw88@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Larishisha Risaw 
Address  NINE,PGIMER,Chandigarh 
Type of Sponsor  Other [Selfexpenditure] 
 
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 
Larishisha Risaw  Advanced Pediatric Centre  PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9855670746

l.risaw88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee(Intamural),PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Advised for blood sampling,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Flippits   Flippits was used during blood sampling to the intervention group 
Comparator Agent  standard care  Routine care for control group during blood sampling  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children who are:
1. In the age group of 4 to 6 years
2. Advised for blood sampling
3. Blood sampling through venous approach.
 
 
ExclusionCriteria 
Details  1. Handicapped children- visual & auditory
2. Physical disability
3. Cognitive impairment 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of distraction by flippits on Behavioral response to pain  During blood sampling 
 
Secondary Outcome  
Outcome  TimePoints 
Diference in response to pain in children in both groups  During blood sampling 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="4" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   EFFICACY OF FLIPPITS TO REDUCE PAIN IN CHILDREN DURING VENIPUNCTURE - A RANDOMIZED CONTROLLED TRIAL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Need and Justification

Many hospitalized children have to undergo painful procedures. Blood sampling is one of the most common painful procedures the child  have to undergo during their hospital stay.  

Challenges to the nurses who provide their care, co- operation of children during painful invasive procedures is very important.  Nurses are in a unique position to improve the management of children’s pain because children and parents will often tell them things they do not tell physician.

Various studies were found that distraction is a proven effective psychological intervention. Distraction is a power relief intervention that children are accustomed to using. Distraction can be used as one of the strategies to gain co-operation of the child. Distraction is the ability to focus attention on something other than pain and does not mean that the pain is gone.

Therefore, the need to create an evidence based approach to assess the effect of distraction by flippits on behavioral response to pain in children during blood sampling can be articulated.

 

 

 

 

 

 

 

 

 

 

 

 

Research statement

A randomized controlled trial to assess the effect of distraction by flippits on behavioral response  to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh  2014-16.

Objectives

1.      To develop protocol for use of distraction during blood sampling.

2.      To assess the effect of distraction by flippits on behavioral response  to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh.

Operational definitions

•      Effect – It refers to change in behavioral response  to pain level brought about by distraction during blood sampling.

•      Distraction – It refers to use of Flippits as a distraction method during blood sampling.

Delimitation of the study

The study is limited to children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh.

Null Hypothesis (H0)

There will be no effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling at 0.05 level of significance.

 

Alternative hypothesis

H1: Distraction by flippits will lead to reduction of behavioral response to pain in children of age group 4 to 6 years during blood sampling at  0.05 level of significance.

 

 

Delimitation of the study

The study is limited to children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh.

Nursing implications of the study:

The findings of the study will:

·         Provide an empirical evidence for using distraction by flippits as an alternative non-pharmacological intervention  in children of age group 4 to 6 years during blood sampling

Direct the nursing personnel to implement distraction by flippits protocol for children of age group 4 to 6 years during blood sampling

RESEARCH METHODOLOGY

 

•      Approach: Quantitative

•      Design: Randomized controlled trial

•      Research setting: The study will be conducted in Advanced Pediatric Centre, PGIMER, Chandigarh.

•      Target population: Children of age group 4 to 6 years who will be advised for blood sampling

•      Study population: Children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh during period of data collection.

•      Sample: The children meeting the eligibility criteria at the time of data collection will be taken.

•      Sample size:  Approx 120 (Experimental: 60; Control: 60)

•      Sampling technique: Block randomization

•      Inclusion criteria:

Children who are:

1.      In the age group of 4 to 6 years

2.      Advised for blood sampling

3.      Blood sampling through venous approach.

•      Exclusion criteria

1.      Handicapped children- visual & auditory

2.      Physical disability

3.      Cognitive impairment

Protocol for Distraction by Flippits

 

·         Flippits consisted of visual cards of 8 cm to 10 cm, covered with various pictures and shapes appropriate for age group.

·         The distraction procedure via Flippits began just before the blood sampling and continued until the end of the blood sampling.

·         In this method, the children first carefully examined the cards.

·         Then, the researcher will ask some questions about those cards to be answered by the children.

Protocol For Assessment Of Pain

Apparatus: One video camera will be used to capture clips of the child behavior right from the time is placed on the examination table till the end of the blood sampling procedure.

Ø  Assessment of pain  will be captured by videotaping using FLACC behavioural pain assessment scale

                

 

                    




 
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