Skip to content

Robots to Reduce Pain During IV Placement

Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02840942
Enrollment
34
Registered
2016-07-21
Start date
2016-09-01
Completion date
2019-07-20
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

intravenous line, robot

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).

Interventions

BEHAVIORALCoping Robot

Socially assistive robot MAKI will interact with children via tablet game designed to teach coping skills.

BEHAVIORALNon-coping Robot

Socially assistive robot MAKI will interact with children via tablet game designed to be distraction only.

Sponsors

University of Southern California
CollaboratorOTHER
Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Scale Score from baseline to post-interventionthrough study completion, an average of 1 hourUsing Wong-baker faces pain scale

Secondary

MeasureTime frameDescription
Patient/Child satisfaction with robot interactionDay 1by survey
CAMPIS scoreDay 1on video review
IV placement attemptsthrough study completion, an average of 1 hourrecord raw number of attempts to compare average between arms
Change in Anxiety Scale Score from baseline to post-interventionthrough study completion, an average of 1 hourusing fear faces scale
heart ratethrough study completion, an average of 1 hourusing pulse oximeter
mYPAS scoreDay 1on video review

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026