Robots to Reduce Pain During IV Placement
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|ClinicalTrials.gov Identifier: NCT02840942|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Anxiety||Behavioral: Coping Robot Behavioral: Non-coping Robot||Not Applicable|
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 hospital's child life specialists (2) usual child life + non-coping robot or (2) usual child life + coping robot.
Prior to the procedure participant's parent (or legal guardian) will complete a short survey related to pain with previous IV insertions, anxiety related to procedures, and attitudes toward robots. Participant's parent/guardian 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. Participant's anxiety level will be assessed using the Children's Fear Scale. Participant's 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 parent/guardian will then be given a short post-survey regarding thoughts on the utility of the interaction and the amount of the participant's 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||July 20, 2019|
|Actual Study Completion Date :||July 20, 2019|
No Intervention: Non-robot
Patients will interact with Child Life as per usual routine, no robot condition
Experimental: Coping Robot
Robot will play coping game with children. Robot will speak and child will respond by touching tablet. Child life still present.
Behavioral: Coping Robot
Socially assistive robot "MAKI" will interact with children via tablet game designed to teach coping skills.
Experimental: Non-coping Robot
Robot will play distraction only game, in addition to Child Life and routine cares
Behavioral: Non-coping Robot
Socially assistive robot "MAKI" will interact with children via tablet game designed to be distraction only.
- Change in Pain Scale Score from baseline to post-intervention [ Time Frame: through study completion, an average of 1 hour ]Using Wong-baker faces pain scale
- IV placement attempts [ Time Frame: through study completion, an average of 1 hour ]record raw number of attempts to compare average between arms
- Patient/Child satisfaction with robot interaction [ Time Frame: Day 1 ]by survey
- CAMPIS score [ Time Frame: Day 1 ]on video review
- mYPAS score [ Time Frame: Day 1 ]on video review
- Change in Anxiety Scale Score from baseline to post-intervention [ Time Frame: through study completion, an average of 1 hour ]using fear faces scale
- heart rate [ Time Frame: through study completion, an average of 1 hour ]using pulse oximeter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840942
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|