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CTRI Number  CTRI/2020/02/023112 [Registered on: 04/02/2020] Trial Registered Prospectively
Last Modified On: 01/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effectiveness of using a pictorial story in reducing the immunization pain in children and the anxiety of mothers between 3-6 years of age when compared to a group receiving a general story and one receiving no intervention. 
Scientific Title of Study   A randomized controlled trial assessing the effectiveness of social stories, in reducing pain perception of children aged 3- 6 years and maternal anxiety during Immunization when compared to a placebo and control group.  
Trial Acronym  STEP IN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Addlin Sarah 
Designation  Student 
Affiliation  Christian Medical College, Vellore 
Address  Department of PMR, Occupational Therapy Unit, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9894269780  
Fax    
Email  addlinsarah2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jerome Dany Praveen Raj 
Designation  Lecturer 
Affiliation  Christian Medical College, Vellore 
Address  Department of PMR, Occupational Therapy Unit, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9894832099  
Fax    
Email  jeromedany18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Addlin Sarah 
Designation  Student 
Affiliation  Christian Medical College, Vellore 
Address  Department of PMR, Occupational Therapy Unit, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9894269780  
Fax    
Email  addlinsarah2@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Fluid Research Grant of Christian Medical College Vellore 
Address  Christian Medical College, Vellore, 632004 
Type of Sponsor  Research institution and hospital 
 
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 
Addlin Sarah A  Christian Medical College   Department of Child Health, Well Baby Immunization clinic.
Vellore
TAMIL NADU 
9894269780

addlinsarah2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pain during routine immunization 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General pictorial story not relevant to immunization.  The comparator agent is a pictorial story not relevant to the immunization procedure. We will be using a story related to a visit to the grocery store. The characters in both stories will be the same. 
Intervention  Social story about the immunization visit.  The intervention consists of using a social story about the immunization visit. The story begins with a mother taking her children to the immunization clinic. She explains to them why they need to be immunized, what will happen at the immunization clinic step by step. The story ends with the mother taking the children home happily. The story will be pictorial and colorful. The text will be in English and in Tamil.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Mothers having knowledge of Tamil or English. Child accompanied by mother.  
 
ExclusionCriteria 
Details  Hospitalization within the past year.
Admission to the NICU in the neonatal period.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception will be assessed using 3 scales, namely Sound, Eye and Motor (SEM) Scale; Observation Scale of Behavioral Distress and The Wong Baker FACES Pain Rating Scale. Anxiety will be assessed by General Anxiety- Visual Analog Scale (GA-VAS).   Pain perception of the child will be assessed before and after the immunization using the Wong Bakers FACES Pain Rating Scale and during the immunization using the Observational Scale of Behavioral Distress. Anxiety in the mothers will be assessed after the intervention using the General anxiety- Visual Analog Scale (GA-VAS). 
 
Secondary Outcome  
Outcome  TimePoints 
Demographic characteristics of the mother will be assessed.
The number and type of distraction techniques will also be noted.  
Demographic characteristics of the mother will be assessed before the intervention and after the consent is received.
The number and type of distraction techniques used will be noted during the immunization procedure. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2020 
Date of Study Completion (India) 06/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Children undergo unpredictable and procedure- related pain in hospitals that have negative emotional implications. These medical procedures cause anxiety, fear and distress not only in the children, but also the families, which further intensifies pain- interfering with the procedure. Maternal psychological symptoms and behaviors influence children’s pain. Even subtle display of parental anxiety can convey powerful messages regarding pain to children.

 Medical procedures involving needles are the most feared experiences as reported by children. If this fear is not addressed, pain can lead to long term consequences such as pre procedural anxiety, health care avoidance behaviors and non adherence to vaccination schedules. Interventions to reduce vaccination pain include: Positioning involving sitting upright rather than lying supine, local anesthetics containing gels, creams and patches. Competency of clinicians administering vaccinations was found to mitigate vaccination pain.

Strong evidence supports educating parents on the effects of pain and its management before and on the day of immunization so that learning happens ahead of time. Education of children three years and older on the day of immunization by providing information of what will happen (procedural information), how it would feel (sensory information) and how to cope (strategies to mitigate pain and fear) have been found to mitigate pain response.

 Social stories (Carol Gray) is an intervention based on providing procedural information by means of pictures. It is a positive, child-focused intervention designed to bridge the gap of a child’s social understanding and promote positive social behaviors.

The primary objective of this study is to develop a social story related to the immunization visit and to assess its effectiveness on pain perception. A story will prepare the child in advance for the immunization procedure in order to reduce pain perception in the age group of 3-6 years and maternal anxiety. Outcome with be compared with two control groups one receiving a placebo intervention involving a general story and one group receiving no intervention.

 
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