Using a Humanoid Robot to Distract Children With Chronic Conditions Undergoing Painful Procedures

Summary

The aim of this study is to examine the effect of using a humanoid robot during a painful puncture procedure (e.g., portal catheter punction, IV punctures, blood withdrawal, etc.) in children with chronic conditions (e.g., chronic immune deficiency, colitis ulcerosa, metabolic disorders, cystic fibrosis, etc.) on the pain and fear memory of child and parent in comparison to usual care. The use of a humanoid robot has proven to be effective on reducing healthy children's pain and distress towards vaccinations. Still, whether these benefits generalize to chronically ill children, to pain/fear memories and to the parents needs to be examined.

The current research proposal is the first one to examine the use of a humanoid robot to distract children with chronic conditions who undergo repeated painful procedures and, compared to usual care, its effectiveness in reducing negative pain and fear experience and reducing negative pain and fear memory biases.

Children aged 8-12y with chronic conditions receiving regular treatment by painful puncture procedures, and their parents will be recruited at the University Hospital Brussels and Ghent. Baseline assessments include child's anticipated pain, pain-related fear and self-efficacy by child's self-report and parent proxy report, child's attention control, attention bias, pressure hyperalgesia, energy-balance related behavior, child's and parent's catastrophizing about the child's pain, parental behavioral responses to their child's pain and parent's emotions towards the child's painful procedure. Stratified block randomization will be used to assign the children to the control group (usual care) or intervention group (robot distraction). Immediately after the puncture procedure, experienced pain, pain-related fear, self-efficacy and pain catastrophizing (state) will be assessed again by child and parent, as well as emotions of the parent. One week post-procedure the participants will be contacted by telephone for a short interview in order to assess child's and parent's pain and pain-related fear memory, as well as child's and parent's future pain, pain-related fear and self-efficacy expectancies using the same scales as administered before and immediately after the procedure, with in addition a free recall and prompted recall about contextual details about the day of the procedure. Recalled pain and pain-related fear ratings that are higher compared to initial reports are considered indicative of negative memory biases.

Conditions

• Chronic Diseases in Children

Interventions

BEHAVIORAL

Usual care

Control group: minimal distraction

BEHAVIORAL

Robot-assisted puncture procedure

Experimental group: distraction with robot

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• University Ghent

  collaborator OTHER

• Vrije Universiteit Brussel

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-30

Primary Completion

2022-02-24

Completion

2022-02-24

Countries

• Belgium

Study Locations