Status:
COMPLETED
Canada-UK AI Study
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of Toronto
Conditions:
Social Robots for Procedural Distress
Eligibility:
All Genders
5-11 years
Phase:
NA
Brief 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 lo...
Detailed Description
PURPOSE: The study team aims to develop and evaluate an artificial intelligence-enhanced socially intelligent robot designed to alleviate children's distress and pain in a clinical setting. HYPOTHES...
Eligibility Criteria
Inclusion
- child aged 5-11 years
- requires IVI
- will receive topical anesthetic for IVI
Exclusion
- medically unstable (CTAS 1, requiring immediate IV insertion)
- unconscious or not fully alert
- visual or auditory impairments
- neurocognitive delays or mental health issues precluding safe interaction with the robot intervention
- sensory impairment to pain (ex. spina bifida)
- parental or child language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
- not accompanied by legal guardian
- previous enrolment in this clinical trial or in the co-design or usability studies
- other reason at the discretion of the clinical staff
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06556329
Start Date
August 15 2024
End Date
May 15 2025
Last Update
November 18 2025
Active Locations (2)
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1
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8