Reducing Children's Distress Towards Flu Vaccinations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tanya Beran, University of Calgary
ClinicalTrials.gov Identifier:
NCT01529021
First received: February 3, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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.
control
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.

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children in the general public and from hospital ages 5-9 years

Criteria

Inclusion Criteria:

  • ages 5-9 years,
  • boys and girls

Exclusion Criteria:

  • children with pervasive developmental disability
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529021

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

No publications provided by University of Calgary

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

Keywords provided by University of Calgary:
Pain management
vaccination
immunization
pediatric
robotics
human-robot interaction

ClinicalTrials.gov processed this record on July 23, 2014