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Reducing Children's Distress Towards Flu Vaccinations

This study has been completed.
Information provided by (Responsible Party):
Tanya Beran, University of Calgary Identifier:
First received: February 3, 2012
Last updated: February 7, 2012
Last verified: February 2012
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.

Children's Distress During Flu Vaccination

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 57
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
humanoid robot distration
The robot NAO, academic edition (Aldebaran Robotics) was used in this study. Some of its features include an on-board fully programmable computer CPU: x86 AMD Geode with 500 MHz, 256 MB SDRAM and 1 GB flash memory, WiFi (802.11g) and Ethernet, two cameras with up to 30 frames per second, two hands with self adaptive gripping abilities, force sensitive sensors on its arms and feet to perceive contact with objects, Light Emission Diodes in its eyes and body, four microphones to identify the source of sounds, and two loud speakers for communication where tone and voice pitch can be modified in real-time. It runs on a native Linux Operating system platform and can be programmed using a proprietary SDK called NaoQi, or in C, C++, Ruby and Urbi, which makes it compatible with other robot simulators such as Microsoft Robotics Developer Studio.
standard care procedures were used during the vaccination

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.

Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children in the general public and from hospital ages 5-9 years

Inclusion Criteria:

  • ages 5-9 years,
  • boys and girls

Exclusion Criteria:

  • children with pervasive developmental disability
  Contacts and Locations
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Please refer to this study by its identifier: NCT01529021

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Principal Investigator: Tanya Beran, PhD University of Calgary
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tanya Beran, Associate Professor, University of Calgary Identifier: NCT01529021     History of Changes
Other Study ID Numbers: E 23795
Study First Received: February 3, 2012
Last Updated: February 7, 2012

Keywords provided by University of Calgary:
Pain management
human-robot interaction

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on April 25, 2017