Using a Humanoid Robot to Distract Children With Chronic Conditions Undergoing Painful Procedures
TerminatedNot applicableNCT04003701
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 inter…
Study details
- Official title
- Using a Humanoid Robot to Distract Children With Chronic Conditions Undergoing Painful Procedures: a Pilot Randomized Controlled Trial Looking at Alterations of Children's and Parents' Pain and Fear Memories
- Conditions
- Chronic Diseases in Children
- Interventions
- Behavioral: Usual care
- Behavioral: Robot-assisted puncture procedure
- Sponsor
- Vrije Universiteit Brussel
- Collaborators
- Universitair Ziekenhuis Brussel; University Ghent
- Start date
- 2019-09-30
- Primary completion
- 2022-02-24
- Sex
- All
- Age range
- from 8 Years to 12 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: All participants: * Chronic disease * Willing to participate and comply with pre-determined interventions * 8-12y (children) * Child and parent(s)/guardian cohabited for the past 5 years or, in case of divided custody, for at least half of the child's lifetime * Currently being treated (not necessarily hospitalized) in the University Hospital Brussels Exclusion Criteria: * Developmental disabilities (e.g.: autism spectrum disorder, Attention Deficit (Hyperactivity) Disorder) * Psychiatric disorders (e.g.: anxiety disorder, personality disorder) * Significant vision or hearing impairment * Not able to read and speak fluent Dutch (parent and child)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04003701