FindTrial
Sign In

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.

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. - STEP IN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023112
Enrollment
45
Registered
2020-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 imm

Sponsors

Fluid Research Grant of Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Hospitalization within the past year. Admission to the NICU in the neonatal period.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Demographic characteristics of the mother will be assessed. 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. The number and type of distraction techniques used will be noted during the immunization procedure.—

Countries

India

Contacts

Public ContactAddlin Sarah

Christian Medical College, Vellore

jeromedany18@gmail.com9894832099

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026