Related Experiment Video
Updated: Feb 1, 2026

SSVEP-based Experimental Procedure for Brain-Robot Interaction with Humanoid Robots
Published on: November 24, 2015
Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in
Samina Ali1,2, Mithra Sivakumar1, Tanya Beran3
1Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Insights
Humanoid robots may reduce pain and distress in children during intravenous insertion (IVI) procedures. This study investigates robot-assisted distraction as a novel approach to improve pediatric patient experience in emergency departments.
Area of Science:
- Pediatric Emergency Medicine
- Human-Robot Interaction
- Pain Management
Background:
- Intravenous insertion (IVI) is a common, yet painful and stressful procedure for children in emergency departments.
- Current distraction therapies are not standard practice for IVI in North America.
- Humanoid robots offer a potential novel approach for distraction therapy.
Purpose of the Study:
- To evaluate the effectiveness of humanoid robot interaction as a distraction technique during IVI in children.
- To compare patient-reported pain and distress between robot-assisted distraction and standard care.
- To assess secondary outcomes including parental anxiety and child engagement with the robot.
Main Methods:
- A randomized controlled superiority trial conducted in a Canadian pediatric emergency department.
- Recruitment of 80 children aged 6-11 years requiring IVI.
- Primary outcomes measured by self-reported pain (Faces Pain Scale-Revised) and observed distress (Observational Scale of Behavioural Distress-Revised).
Main Results:
- Study is ongoing with pre-results available.
- Primary outcomes (pain and distress) and secondary outcomes (parental anxiety, child engagement) are being collected.
- Data collection began in April 2017 and is continuing.
Conclusions:
- Humanoid robot distraction shows promise for reducing pediatric pain and distress during IVI.
- This intervention could become a valuable addition to standard care in pediatric emergency settings.
- Further results are anticipated upon study completion.
Introduction:
Intravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress.
Methods And Analysis:
This randomised controlled superiority trial will be conducted in a Canadian paediatric ED. We plan to recruit 80 patients. Children will be eligible if they (1) are 6 to 11 years of age, (2) need an IVI, (3) are fully conscious and alert, (4) have sufficient knowledge of the English language to understand and complete the study assessments and (5) are accompanied by a legal guardian. Our primary objective is to compare patient-reported pain and distress with the use of distraction (via a humanoid robot) versus standard care in children. The primary outcomes will be (1) self-reported pain, as measured by the Faces Pain Scale-Revised and (2) observed distress, as measured by the Observational Scale of Behavioural Distress-Revised. Secondary outcomes will include (1) measuring parental anxiety, (2) examining the association between parental anxiety and child outcomes and (3) children's degree of engagement with the humanoid robot via the Intrinsic Motivation Inventory tool. First enrolment occurred in April 2017 and is ongoing.
Ethics And Dissemination:
This study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent to participate will be obtained from all participants' parents/guardian, in conjunction with assent from the participant themselves. This study data will be submitted for publication regardless of results. Purchase of the robot was facilitated through a Stollery Children's Hospital Foundation donation. Recruitment costs are supported by the Women and Children's Health Research Institute.
Trial Registration Number:
NCT02997631; Pre-results.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Clinical Trials: Overview
Trial and Error and Algorithm
Clinical Trials
There are four phases in a clinical trial. A phase one...
Pain
Drug Dosing: Infants and Children

