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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
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Children's Hospital Los Angeles

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE September 1, 2016
Actual Primary Completion Date July 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02840942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robots to Reduce Pain During IV Placement
Official Title  ICMJE Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement
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 Children's Hospital Los Angeles (CHLA) to reduce children's 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain
  • Anxiety
Intervention  ICMJE
  • Behavioral: Coping Robot
    Socially assistive robot "MAKI" will interact with children via tablet game designed to teach coping skills.
  • Behavioral: Non-coping Robot
    Socially assistive robot "MAKI" will interact with children via tablet game designed to be distraction only.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Coping Robot
  • Experimental: Non-coping Robot
    Robot will play distraction only game, in addition to Child Life and routine cares
    Intervention: Behavioral: Non-coping Robot
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
34
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2016)
100
Actual Study Completion Date  ICMJE July 20, 2019
Actual Primary Completion Date July 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Speaks English or Spanish
  • Age limits
  • would be getting IV and child life regardless of participation in study

Exclusion Criteria:

  • severe developmental delay (parent assessment)
  • afraid of robots
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840942
Other Study ID Numbers  ICMJE CHLA-14-00231
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Children's Hospital Los Angeles
Study Sponsor  ICMJE Children's Hospital Los Angeles
Collaborators  ICMJE University of Southern California
Investigators  ICMJE Not Provided
PRS Account Children's Hospital Los Angeles
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP