Reducing Children's Distress Towards Flu Vaccinations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01529021

Enrollment

Registered

2012-02-08

Start date

2011-10-31

Completion date

2011-11-30

Last updated

2012-02-08

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

Conditions

Children's Distress During Flu Vaccination

Keywords

Pain management, vaccination, immunization, pediatric, robotics, human-robot interaction

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 9 Years

Healthy volunteers

Yes

Inclusion criteria

* ages 5-9 years, * boys and girls

Exclusion criteria

* children with pervasive developmental disability

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results