Reducing Children's Distress Towards Flu Vaccinations

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT01529021

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

57 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Faces Pain Scale-Revised [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ages 5-9 years,
boys and girls

Exclusion Criteria:

children with pervasive developmental disability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alberta Children's Hospital	Calgary	Alberta	Canada	T3B 6A8

Sponsors and Collaborators

University of Calgary

Investigators

Principal Investigator: Tanya Beran, PhD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tanya Beran, Associate Professor, University of Calgary

ClinicalTrials.gov Identifier:

NCT01529021

Other Study ID Numbers:

E 23795

First Posted:

Feb 8, 2012

Last Update Posted:

Feb 8, 2012

Last Verified:

Feb 1, 2012

Keywords provided by Tanya Beran, Associate Professor, University of Calgary

human-robot interaction

Study Results

No Results Posted as of Feb 8, 2012