Reducing Children's Distress Towards Flu Vaccinations

Completed

• Conditions: Children's Distress During Flu Vaccination

• Registration Number: NCT01529021
• Lead Sponsor: University of Calgary

Brief Summary

Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Children frequently use technologically advanced devices such as computers and cell phones. Based on this familiarity, the investigators introduced another sophisticated device - a humanoid robot to- interact with children during their vaccination. The investigators hypothesized that these children would experience less distress than children who did not have this interaction.

Detailed Description

57 children (30 male; age, mean + SD: 6.87 + 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. Measures of distress were completed by children, parents, nurses, and researchers.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-07
• Last Update Submitted: 2012-02-07
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• ages 5-9 years,
• boys and girls

Exclusion Criteria

• children with pervasive developmental disability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faces Pain Scale-Revised	5 mins before and immediate after vaccination	The Faces Pain Scale-Revised was administered to children and their parents while in the waiting room and after consent was signed. Once this questionnaire and consent were completed, the parent and child entered the vaccination room for the vaccination. As soon as the vaccination was completed, the Faces Pain Scale-Revised was re-administered.

Secondary Outcome Measures

Name	Time	Method
Behavioral Approach-Avoidance Distress Scale	one week after vaccination was administered	The Behavioral Approach-Avoidance Distress Scale was used by researchers one week after the data collection phase was completed while reviewing the videos.

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada