Ignite Creation Date:
2024-05-06 @ 8:52 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02840942
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2016-05-20
Brief Title:
Robots to Reduce Pain During IV Placement
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Socially Assistive Robots to Reduce Childrens Pain During Peripheral IV Placement
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peripheral intravenous catheters IVs are utilized in the majority of hospitalized children The placement of IVs requires significant staff time contributes to health care costs and causes pain and distress in the patients receiving them Techniques currently used at Childrens Hospital Los Angeles CHLA to reduce childrens anxiety and increase success of IV placement center depends on members of the Child Life Department distracting patients during insertion Recent literature has suggested that humanoid robots can be a powerful form of distraction and lead to decreased pain during painful procedures in children Work done by the University of Southern California USC Interaction Lab has shown that socially assistive robots can use techniques more complex than pure distraction to lead to a human-robot interaction that is perceived as more positive by the human The investigators propose a project pairing children receiving an IV with either a 1 Child Life staff member only 2 pure distraction robot Child Life or 3 an robot teaching coping skills Child Life with a goal of reduced pain Pain will be measured by participant self-report family member perceived pain parasympathetic activation and pain behaviors as measured by video
Detailed Description:
At USC University Park computer science collaborators have programmed the robot to speak the script which will be used for interaction with participants see additional supporting documents
At CHLA patients arriving to the radiology suite for IV placement prior to MRI and utilizing Child Life Services will be approached and consented for inclusion No participant will receive a IV purely for the purpose of the study only participants already ordered to receive IV by the medical team will be included After consent participants will be randomized in blocks using a random-condition generating document to one of three test conditions 1 control with the usual distraction services provided by one of the hospitals child life specialists 2 usual child life non-coping robot or 2 usual child life coping robot
Prior to the procedure participants parent or legal guardian will complete a short survey related to pain with previous IV insertions anxiety related to procedures and attitudes toward robots Participants parentguardian will also complete a validated measure of child temperament Participants will complete a baseline measure of their temperament Participants will then rate current level of pain using the Wong-Baker FACES scale Participants anxiety level will be assessed using the Childrens Fear Scale Participants baseline heart rate and blood pressure is recorded
The IV placement itself will be video recorded for all conditions Independent assessors not aware of the research aims will review the tape to score measures of the strength of robot-child interaction and pain behaviors One research team member will record the number of attempts needed to place the IV A trained research team member will be responsible for operating the robot if randomized to that condition
The robot used is the MAKI - an open-source 3D printable robot designed by Hello Robo Inc The company has not provided any funding to this project During the interaction the robot will speak in a child-like gender neutral voice It will ask short questions of participants and have pre-recorded response options see MAKI script in supporting documents Participants will interact with either child life or the robot by touching tablets This is a minimum risk study similar to the risk involved in watching a video on a screen The robot is small and only moves its facial features participants are not touching it
Pre- and post-intervention participants will repeat the FACES and Fear Scales The participant and parentguardian will then be given a short post-survey regarding thoughts on the utility of the interaction and the amount of the participants pain Heart rate will be monitored continuously throughout the interaction Videos will be evaluated using the modified Yale Preoperative Anxiety Index and The Child-Adult Medical Procedure Interaction Scale-Short Form CAMPIS-SF
At CHLA patients arriving to the radiology suite for IV placement prior to MRI and utilizing Child Life Services will be approached and consented for inclusion No participant will receive a IV purely for the purpose of the study only participants already ordered to receive IV by the medical team will be included After consent participants will be randomized in blocks using a random-condition generating document to one of three test conditions 1 control with the usual distraction services provided by one of the hospitals child life specialists 2 usual child life non-coping robot or 2 usual child life coping robot
Prior to the procedure participants parent or legal guardian will complete a short survey related to pain with previous IV insertions anxiety related to procedures and attitudes toward robots Participants parentguardian will also complete a validated measure of child temperament Participants will complete a baseline measure of their temperament Participants will then rate current level of pain using the Wong-Baker FACES scale Participants anxiety level will be assessed using the Childrens Fear Scale Participants baseline heart rate and blood pressure is recorded
The IV placement itself will be video recorded for all conditions Independent assessors not aware of the research aims will review the tape to score measures of the strength of robot-child interaction and pain behaviors One research team member will record the number of attempts needed to place the IV A trained research team member will be responsible for operating the robot if randomized to that condition
The robot used is the MAKI - an open-source 3D printable robot designed by Hello Robo Inc The company has not provided any funding to this project During the interaction the robot will speak in a child-like gender neutral voice It will ask short questions of participants and have pre-recorded response options see MAKI script in supporting documents Participants will interact with either child life or the robot by touching tablets This is a minimum risk study similar to the risk involved in watching a video on a screen The robot is small and only moves its facial features participants are not touching it
Pre- and post-intervention participants will repeat the FACES and Fear Scales The participant and parentguardian will then be given a short post-survey regarding thoughts on the utility of the interaction and the amount of the participants pain Heart rate will be monitored continuously throughout the interaction Videos will be evaluated using the modified Yale Preoperative Anxiety Index and The Child-Adult Medical Procedure Interaction Scale-Short Form CAMPIS-SF
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