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
|
|
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
|
|
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. |