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.

Not Applicable

Completed

• Registration Number: CTRI/2020/02/023112
• Lead Sponsor: Fluid Research Grant of Christian Medical College Vellore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-05-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Mothers having knowledge of Tamil or English. Child accompanied by mother.

Exclusion Criteria

Hospitalization within the past year.

Admission to the NICU in the neonatal period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).Timepoint: 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 Measures

Name	Time	Method
Demographic characteristics of the mother will be assessed. <br/ ><br>The number and type of distraction techniques will also be noted.Timepoint: Demographic characteristics of the mother will be assessed before the intervention and after the consent is received. <br/ ><br>The number and type of distraction techniques used will be noted during the immunization procedure.