MEDi Robot for Pain Management at Induction
Efficacy of a Preparation Intervention for the Management of Children's Pain and Fear During Induction: Help From a Robot Named MEDi
1 other identifier
interventional
137
1 country
1
Brief Summary
The purpose of this study is to determine if a preparation teaching intervention before IV insertion, taught by MEDi to children and their parents, will lead to lower levels of expected and experienced pain and fear and less distressing pain memories, as compared to children who receive standard care. In addition, it will be examined whether this preparation intervention will lead to greater parental self-efficacy, less anxiety, and less distressing pain memories as compared to controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2018
CompletedApril 27, 2021
April 1, 2021
1.9 years
July 28, 2016
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
child's pain
Faces Pain Scale-Revised (FPS-R) (Hicks, 2001)
at moment of child's IV start
Secondary Outcomes (5)
child's fear
at the moment of OR entry
parent self-efficacy
30 mins to 3 hours before induction
parent anxiety
30 mins to 3 hours before induction
children's memory
2 weeks after child's induction
parents' memory
2 weeks after child's induction
Study Arms (2)
control
NO INTERVENTIONNo intervention
robot
EXPERIMENTALHumanoid robot interacts with child, teaching breathing and coping strategies.
Interventions
Humanoid robot programmed with cognitive-behavioral interventions such as role modeling, teaching coping strategies, positive reinforcement, parent encouragement
Eligibility Criteria
You may qualify if:
- presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2
You may not qualify if:
- patient presenting for day surgery
- patient requires an intravenous placed in day surgery unit
- patient cognitively unable to self-report pain
- patient with a hearing or visual impairment or developmental disability that precludes self-reporting ability
- family or child that is unable to communicate in English
- previous allergic reaction to propofol or lidocaine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Alberta Health servicescollaborator
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 8, 2016
Study Start
July 8, 2016
Primary Completion
May 25, 2018
Study Completion
May 25, 2018
Last Updated
April 27, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share