NCT02840942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

May 20, 2016

Last Update Submit

January 9, 2024

Conditions

PainAnxiety

Keywords

intravenous linerobot

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Scale Score from baseline to post-intervention

    Using Wong-baker faces pain scale

    through study completion, an average of 1 hour

Secondary Outcomes (6)

  • IV placement attempts

    through study completion, an average of 1 hour

  • Patient/Child satisfaction with robot interaction

    Day 1

  • CAMPIS score

    Day 1

  • mYPAS score

    Day 1

  • Change in Anxiety Scale Score from baseline to post-intervention

    through study completion, an average of 1 hour

  • +1 more secondary outcomes

Study Arms (3)

Non-robot

NO INTERVENTION

Patients will interact with Child Life as per usual routine, no robot condition

Coping Robot

EXPERIMENTAL

Robot will play coping game with children. Robot will speak and child will respond by touching tablet. Child life still present.

Behavioral: Coping Robot

Non-coping Robot

EXPERIMENTAL

Robot will play distraction only game, in addition to Child Life and routine cares

Behavioral: Non-coping Robot

Interventions

Coping RobotBEHAVIORAL

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

Coping Robot
Non-coping RobotBEHAVIORAL

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

Non-coping Robot

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • severe developmental delay (parent assessment)
  • afraid of robots

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (3)

  • Okita SY. Self-other's perspective taking: the use of therapeutic robot companions as social agents for reducing pain and anxiety in pediatric patients. Cyberpsychol Behav Soc Netw. 2013 Jun;16(6):436-41. doi: 10.1089/cyber.2012.0513. Epub 2013 Mar 18.

    PMID: 23505968BACKGROUND

  • Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24.

    PMID: 23623861BACKGROUND

  • Trost MJ, Chrysilla G, Gold JI, Mataric M. Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children. Pain Res Manag. 2020 Apr 9;2020:7935215. doi: 10.1155/2020/7935215. eCollection 2020.

    PMID: 32351642DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

May 20, 2016

First Posted

July 21, 2016

Study Start

September 1, 2016

Primary Completion

July 20, 2019

Study Completion

July 20, 2019

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

US(1)