Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556329
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Canada-UK AI Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Artificial Intelligence AI - Enhanced Social Robots to Improve Childrens Healthcare Experiences
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Canada-UK AI
Brief Summary:
Children experience pain and distress in clinical settings every day The negative consequences of unaddressed pain can be both short-term eg fear distress inability to perform procedures and long-term eg 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
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
Detailed Description:
PURPOSE
The study team aims to develop and evaluate an artificial intelligence-enhanced socially intelligent robot designed to alleviate childrens distress and pain in a clinical setting
HYPOTHESIS
The study team believes that interaction with a robust adaptive socially intelligent robot can effectively distract children during painful clinical procedures thereby reducing pain and distress
JUSTIFICATION
A recent review examined eight studies where a robot was used to reduce childrens pain and distress overall while the results seem promising there is also a need for improved methodology and measures to draw conclusions In particular the authors suggest more effective interventions could be created by ensuring that healthcare experts and engineers collaborate from the start and that user and family partners contribute to a user-centred design process Our proposed work includes such family input and research team collaboration Previous reviews have also identified an urgent need to increase the autonomy of the robots to improve their robustness and adaptability Our project will aim to address this by developing and evaluating a responsive AI-enhanced social robot
In addition as AI systems such as robots grow more pervasive in daily life understanding the impact of such systems on society has become ever more crucial For social robots in particular an important consideration is determining the social role that the robot should play as well as an ethical and appropriate means of making clear the capabilities of the robot
METHODS
Months 24-36 University of Alberta University of Toronto
The goal is to conduct a clinical trial of the robot system developed in Study Design This randomized controlled superiority trial will consist of two arms 1 The Standard of Care Control Arm will include topical anesthetic cream as well as a combination of parental support child life services andor healthcare provider support at the discretion of the treating team and family 2 The Robot Intervention Arm will include the addition of robot distraction to current departmental standard of care Distraction will include interaction with a socially intelligent autonomous humanoid robot the development of which will be informed by the earlier stages of this study co-design and usability phases
Primary Objective Our primary objective of is to 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 intravenous insertion IVI
Secondary Objectives The secondary objectives are a to compare the reduction of fear in the robot intervention versus standard of care arms b to compare the reduction of parentalcaregiver anxiety with their childs use of robot intervention versus standard of care c to compare child parentalcaregiver and nurse satisfaction with the procedure in the intervention versus standard of care arms d to examine the association between parentalcaregiver anxiety and child outcomes ie pain distress fear e to assess childrens degree of engagement with the socially intelligent autonomous humanoid robot and f to assess the ethical needs and issues related to interaction with a socially intelligent autonomous humanoid robot
Data Collection Research Assistants RAs will screen the electronic emergency department trackboard and communicate with on-site clinical staff to identify potentially eligible patients For children flagged as requiring an IVI the RA will further assess eligibility and acquire informed consent assent as appropriate The RA will then gather baseline demographic history information and access a secure Research Electronic Data Capture REDCap randomization tool to determine the childs group assignment ie either Robot intervention or Control group
Approximately five minutes prior to the start of the procedure defined as cleaning of the IV site the RA will begin the video recording and collect pre-procedure pain fear and parental anxiety measures For children randomized to the intervention group the RA will bring in the robot and explain how to interact with it The clinical nurse will then insert the IV following standard institutional protocols For children randomized to the intervention group the RA will bring in the robot and explain how to interact with it The clinical nurse will then insert the IV following standard institutional protocols Immediately following the first attempt at IVI regardless of success the RA will repeat the pain fear and parental anxiety measures Within 5-10 minutes of the procedure satisfaction and acceptability questionnaires will be completed with the child parent caregiver and the clinical nurse Video recording will conclude 5 minutes after the procedure and only one attempt will be recorded regardless of success of the IVI Video recording will allow for coding of OSBD-R distress scores at a later time Visit details will be collected from the childs medical chart
Setting and Sample The study team plans to recruit 85-90 patients in total Patients will be recruited from the emergency departments of the Stollery Childrens Hospital Edmonton and SickKids Toronto
PLAN FOR DATA ANALYSIS clinical data
Statistical analyses will be conducted using statistical software Statisical Analysis Software SAS version 9 SAS Institute Cary North Carolina Baseline variables will be described using appropriate summary statistics For pain during the procedure the mean or median if appropriate scores will be compared between the two groups using independent samples t-tests normal distribution or Mann-Whitney U-tests skewed For Observational Scale of Behavioral Distress-Revised OSBD-R a change score during procedure minus pre-procedure will be calculated for each child and the mean change scores will be compared between study groups Mann-Whitney U test Multiple linear regression analyses will be conducted with distress as the response variable baseline pain and group indicators as explanatory variables and possible effect modifiers ie age sex Intention-to-treat approach will be used The significance level is set at 005
The study team aims to develop and evaluate an artificial intelligence-enhanced socially intelligent robot designed to alleviate childrens distress and pain in a clinical setting
HYPOTHESIS
The study team believes that interaction with a robust adaptive socially intelligent robot can effectively distract children during painful clinical procedures thereby reducing pain and distress
JUSTIFICATION
A recent review examined eight studies where a robot was used to reduce childrens pain and distress overall while the results seem promising there is also a need for improved methodology and measures to draw conclusions In particular the authors suggest more effective interventions could be created by ensuring that healthcare experts and engineers collaborate from the start and that user and family partners contribute to a user-centred design process Our proposed work includes such family input and research team collaboration Previous reviews have also identified an urgent need to increase the autonomy of the robots to improve their robustness and adaptability Our project will aim to address this by developing and evaluating a responsive AI-enhanced social robot
In addition as AI systems such as robots grow more pervasive in daily life understanding the impact of such systems on society has become ever more crucial For social robots in particular an important consideration is determining the social role that the robot should play as well as an ethical and appropriate means of making clear the capabilities of the robot
METHODS
Months 24-36 University of Alberta University of Toronto
The goal is to conduct a clinical trial of the robot system developed in Study Design This randomized controlled superiority trial will consist of two arms 1 The Standard of Care Control Arm will include topical anesthetic cream as well as a combination of parental support child life services andor healthcare provider support at the discretion of the treating team and family 2 The Robot Intervention Arm will include the addition of robot distraction to current departmental standard of care Distraction will include interaction with a socially intelligent autonomous humanoid robot the development of which will be informed by the earlier stages of this study co-design and usability phases
Primary Objective Our primary objective of is to 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 intravenous insertion IVI
Secondary Objectives The secondary objectives are a to compare the reduction of fear in the robot intervention versus standard of care arms b to compare the reduction of parentalcaregiver anxiety with their childs use of robot intervention versus standard of care c to compare child parentalcaregiver and nurse satisfaction with the procedure in the intervention versus standard of care arms d to examine the association between parentalcaregiver anxiety and child outcomes ie pain distress fear e to assess childrens degree of engagement with the socially intelligent autonomous humanoid robot and f to assess the ethical needs and issues related to interaction with a socially intelligent autonomous humanoid robot
Data Collection Research Assistants RAs will screen the electronic emergency department trackboard and communicate with on-site clinical staff to identify potentially eligible patients For children flagged as requiring an IVI the RA will further assess eligibility and acquire informed consent assent as appropriate The RA will then gather baseline demographic history information and access a secure Research Electronic Data Capture REDCap randomization tool to determine the childs group assignment ie either Robot intervention or Control group
Approximately five minutes prior to the start of the procedure defined as cleaning of the IV site the RA will begin the video recording and collect pre-procedure pain fear and parental anxiety measures For children randomized to the intervention group the RA will bring in the robot and explain how to interact with it The clinical nurse will then insert the IV following standard institutional protocols For children randomized to the intervention group the RA will bring in the robot and explain how to interact with it The clinical nurse will then insert the IV following standard institutional protocols Immediately following the first attempt at IVI regardless of success the RA will repeat the pain fear and parental anxiety measures Within 5-10 minutes of the procedure satisfaction and acceptability questionnaires will be completed with the child parent caregiver and the clinical nurse Video recording will conclude 5 minutes after the procedure and only one attempt will be recorded regardless of success of the IVI Video recording will allow for coding of OSBD-R distress scores at a later time Visit details will be collected from the childs medical chart
Setting and Sample The study team plans to recruit 85-90 patients in total Patients will be recruited from the emergency departments of the Stollery Childrens Hospital Edmonton and SickKids Toronto
PLAN FOR DATA ANALYSIS clinical data
Statistical analyses will be conducted using statistical software Statisical Analysis Software SAS version 9 SAS Institute Cary North Carolina Baseline variables will be described using appropriate summary statistics For pain during the procedure the mean or median if appropriate scores will be compared between the two groups using independent samples t-tests normal distribution or Mann-Whitney U-tests skewed For Observational Scale of Behavioral Distress-Revised OSBD-R a change score during procedure minus pre-procedure will be calculated for each child and the mean change scores will be compared between study groups Mann-Whitney U test Multiple linear regression analyses will be conducted with distress as the response variable baseline pain and group indicators as explanatory variables and possible effect modifiers ie age sex Intention-to-treat approach will be used The significance level is set at 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None