Canada-UK AI Study
NCT Number: NCT06556329
Acronym: Canada-UK AI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Robots for Procedural Distress
Interventions: OTHER: Robot (Intervention)
Sponsor: University of Alberta
Collaborators: University of Toronto
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08

Summary:
Children experience pain and distress in clinical settings every day. The negative consequences of unaddressed pain can be both short-term (e.g. fear, distress, inability to perform procedures) and long-term (e.g. needle phobia, anxiety).

In previous small studies, a humanoid robot has been used to deliver cognitive-behavioural therapy during needle procedures. The results of these early studies have been positive, showing high acceptance among children as well as promising initial clinical results. However, these studies all had critical technical limitations: the robot was remotely operated and used purely scripted behaviour with limited Artificial Intelligence support. This reduced the potential to offer personalized support to children. In this project, the study team aims to address this limitation by developing and evaluating a clinically relevant and responsive artificial intelligence-enhanced social robot.

Primary Outcome Measures: Self-reported pain level, Compare the reduction of pain with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI.

The investigators will use the following scales:

- Pain score: Faces Pain Scale-Revised (score: 0-10; 10 being worst pain), Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)|Self-reported distress level, Compare the reduction of pain and distress with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI.

The investigators will use the following scales:

- Distress score: Numerical rating scale (score: 0-10; 10 being most distressed), Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)
Secondary Outcome Measures: Self-reported fear level, To compare the reduction of fear in the robot intervention versus standard of care arms.

The investigators will use the following scale:

- Children's Fear Scale (score: 0-4; 4 being the most scared), Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)|Parental/caregiver anxiety, To compare the reduction of parental/caregiver anxiety with their child's use of robot intervention versus standard of care.

The investigators will use the following scale:

- State Trait Anxiety Inventory, Form Y-1 (STAI) (score: sum 20-80; higher score = more anxious), Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)|Satisfaction with procedure, To compare child, parental/caregiver and nurse satisfaction with the procedure in the intervention versus standard of care arms.

The investigators will use the following scales:

- 5-point Likert scales asking questions on satisfaction (overall IV insertion, pain management, agreeability to use same distraction tool), Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure)|Engagement, To assess children's degree of engagement with the socially intelligent, autonomous humanoid robot.

- Assessed by the standard Robot Semantic Attribute Scale (18-item scale); score: sum 18-126; higher score = better engagement, Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure)