Reducing Children's Distress Towards Flu Vaccinations

Children's Distress During Flu Vaccination Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529021
• Other study ID #: E 23795
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: February 7, 2012
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

• ages 5-9 years,

• boys and girls

Exclusion Criteria:

• children with pervasive developmental disability

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children's Distress During Flu Vaccination

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faces Pain Scale-Revised	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.	5 mins before and immediate after vaccination	No
Secondary	Behavioral Approach-Avoidance Distress Scale	The Behavioral Approach-Avoidance Distress Scale was used by researchers one week after the data collection phase was completed while reviewing the videos.	one week after vaccination was administered	No