Reducing Children's Distress Towards Flu Vaccinations

NCT ID: NCT01529021

Last Updated: 2012-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Children's Distress During Flu Vaccination

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

control

standard care procedures were used during the vaccination

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ages 5-9 years,
* boys and girls

Exclusion Criteria

* children with pervasive developmental disability
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Tanya Beran

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanya Beran, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24.

Reference Type DERIVED
PMID: 23623861 (View on PubMed)

Other Identifiers

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E 23795

Identifier Type: -

Identifier Source: org_study_id

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