Reducing Children's Distress Towards Flu Vaccinations

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.

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Key information

Conditions

Children's Distress During Flu Vaccination Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ages 5-9 years,
boys and girls

Exclusion criteria

children with pervasive developmental disability

Treatment and study plan

Primary outcomes

Faces Pain Scale-Revised

Time frame: 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 outcomes

Behavioral Approach-Avoidance Distress Scale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Feb 8, 2012
Registry last updated: Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed