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

NCT04003701 | Terminated

• 1 other identifier: ROBOTDISTR_RCT_RE_2019-2020
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

children; humanoid robot; distraction; pain; pain memory

Outcome Measures

Primary Outcomes (4)

• Pain memory bias (numeric rating scale) (child)

  Pain rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  1 week post-intervention (calculation method = T3-T1 and T3-T2)

• Pain memory bias (faces pain scale - revised) (child)

  Pain rated by self-report using the Faces Pain Scale Revised (FPS-R) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).

  1 week post-intervention (calculation method = T3-T1 and T3-T2)

• Pain-related fear memory bias (numeric rating scale) (child)

  Pain-related fear rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).

  1 week post-intervention (calculation method = T3-T1 and T3-T2)

• Pain-related fear memory bias (children's fear scale) (child)

  Pain-related fear rated by self-report using the Children's Fear Scale (CFS) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).

  1 week post-intervention (calculation method = T3-T1 and T3-T2)

Secondary Outcomes (36)

• pain intensity (numeric rating scale) (self-report child)

  Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3)

• pain intensity (numeric rating scale) (proxy report parent)

  Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3)

• pain intensity (faces pain scale - revised) (self-report child)

  Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3)

• pain intensity (faces pain scale - revised) (proxy report parent)

  Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3)

• pain-related fear (numeric rating scale) (self-report child)

  Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3)

Other Outcomes (5)

• Pain catastrophizing (trait) (child)

  Day before the intervention (T0)

• Pain catastrophizing (state) (child)

  Just before the intervention (T1) and immediately after the intervention (T2)

• Pain catastrophizing (trait) (parent)

  Day before the intervention (T0)

Study Arms (2)

Usual care group (control group)

ACTIVE COMPARATOR

Within the usual care, no one of the attendees in the room will have specific interaction with the child during this procedure, with the exception of normal/necessary interaction by the nurse and/or parent. Only minimal distraction is allowed. The child will sit down on the treatment table with the legs stretched out in front of him and the puncture-side arm in a 90-90 position next to the head or stretched out and lying down along the body, with the nurse at the puncture side and the parent at the other side standing next to him. The researcher is also present in the room, within the child's field of vision. At the end of the procedure, the nurse tells the child that he/she did very well.

Behavioral: Usual care

Robot-assisted puncture procedure (experimental group)

EXPERIMENTAL

During the experimental intervention, the child, a nurse, one of the parents/guardians, a researcher and the humanoid robot NAO (H25 Academic Edition, Aldebaran Robotics, Paris, France) will be present in the same room. The child will sit down in the same position as with the usual care. Next to the patient a humanoid robot of three-foot tall will sit on eye level on a slanted reading table, at the non-puncture side. The nurse will carry out the puncture procedure as performed as usual. The robot is programmed to distract the child during the entire procedure (before, during and after the puncture) by playing a game with the child based on his/her interests. The child can therefore choose between a number of games in different themes. In the end the robot tells the child that he/she did very well. During the whole intervention, the robot will be re-activated for each phase only when the child and the nurse are ready.

Behavioral: Robot-assisted puncture procedure

Interventions

Usual care BEHAVIORAL

Control group: minimal distraction

Usual care group (control group)

Robot-assisted puncture procedure BEHAVIORAL

Experimental group: distraction with robot

Robot-assisted puncture procedure (experimental group)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All participants:
• Chronic disease
• Willing to participate and comply with pre-determined interventions
• y (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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• University Ghent: collaborator

Study Sites (1)

University Hospital Brussels

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (5)

• Pickrell JE, Heima M, Weinstein P, Coolidge T, Coldwell SE, Skaret E, Castillo J, Milgrom P. Using memory restructuring strategy to enhance dental behaviour. Int J Paediatr Dent. 2007 Nov;17(6):439-48. doi: 10.1111/j.1365-263X.2007.00873.x.

  PMID: 17935597 BACKGROUND

• McKinley S, Coote K, Stein-Parbury J. Development and testing of a Faces Scale for the assessment of anxiety in critically ill patients. J Adv Nurs. 2003 Jan;41(1):73-9. doi: 10.1046/j.1365-2648.2003.02508.x.

  PMID: 12519290 BACKGROUND

• Batson CD, Fultz J, Schoenrade PA. Distress and empathy: two qualitatively distinct vicarious emotions with different motivational consequences. J Pers. 1987 Mar;55(1):19-39. doi: 10.1111/j.1467-6494.1987.tb00426.x.

  PMID: 3572705 BACKGROUND

• Miro J, Castarlenas E, Huguet A. Evidence for the use of a numerical rating scale to assess the intensity of pediatric pain. Eur J Pain. 2009 Nov;13(10):1089-95. doi: 10.1016/j.ejpain.2009.07.002. Epub 2009 Sep 1.

  PMID: 19726211 BACKGROUND

• Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9.

  PMID: 2367140 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 1, 2019
• Study Start: September 30, 2019
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

BE (1)