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Reducing Children's Distress Towards Flu Vaccinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529021
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
Tanya Beran, 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.

Condition or disease
Children's Distress During Flu 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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : October 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529021

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tanya Beran, Associate Professor, University of Calgary Identifier: NCT01529021     History of Changes
Other Study ID Numbers: E 23795
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by Tanya Beran, University of Calgary:
Pain management
human-robot interaction
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs