Reducing Children's Distress Towards Flu Vaccinations

Study Overview
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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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 5-9 years, boys and girls Exclusion Criteria: children with pervasive developmental disability

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| humanoid robot distration<br>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<br>standard care procedures were used during the vaccination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faces Pain Scale-Revised | 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. | 5 mins before and immediate after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Approach-Avoidance Distress Scale | The Behavioral Approach-Avoidance Distress Scale was used by researchers one week after the data collection phase was completed while reviewing the videos. | one week after vaccination was administered | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, vaccination, immunization, pediatric, robotics, human-robot interaction