Abstract
Objectives
Our objectives were to evaluate the effectiveness of humanoid robot-based distraction on reducing distress and pain in children undergoing intravenous insertion.
Methods
A two-arm, open-label randomized controlled trial was conducted April 2017–May 2018, in a pediatric emergency department (ED). A sample of 86 children aged 6–11 years who required intravenous insertion were recruited. Exclusion criteria included hearing/visual impairments, neurocognitive delay, sensory impairment to pain, previous enrollment, and ED clinical staff discretion. Outcome measures included the Observed Scale of Behavioral Distress-Revised (OSBD-R) (distress) and the Faces Pain Scale-Revised (FPS-R) (pain).
Results
Of the 86 children recruited (median age 9 years, IQR 7,10); 55% (47/86) were male, 9% (7/82) were premature, 82% (67/82) had a previous ED visit, 31% (25/82) had a previous hospitalization and 78% (64/82) had previous intravenous insertion. Ninety-six percent (78/81) received topical anesthetic prior to intravenous insertion. Total OSBD-R distress score was 1.49 ± 2.36 (standard care) versus 0.78 ± 1.32 (robot) (p < 0.05). FPS-R pain score was 4 (IQR 2,6) (standard care) versus 2 (IQR 0,4) (robot) (p = 0.13). Parental anxiety immediately after the procedure was 36.7 (11.1) (standard care) versus 31.3 (8.5) (robot) (p = 0.04). Parents were more satisfied with pain management in the robotic distraction group (95% vs 72% very satisfied) (p = 0.002).
Conclusions
Humanoid robot-based distraction therapy is associated with a modest positive impact on child distress for pediatric intravenous insertion, but not pain. It can be considered a potential tool in the ED toolkit for procedural pain-associated distress reduction.
Clinical trial registration
Clinicaltrials.gov Identifier: NCT02997631.
Résumé
Objectifs
Nos objectifs étaient d'évaluer l'efficacité de la distraction robotique humanoïde pour réduire la détresse et la douleur chez les enfants subissant une insertion intraveineuse.
Méthodes
Un essai contrôlé randomisé ouvert à deux bras a été mené d'avril 2017 à mai 2018, dans un service d'urgence pédiatrique. Un échantillon de 86 enfants âgés de 6 à 11 ans ayant besoin d'une insertion intraveineuse a été recruté. Les critères d'exclusion comprenaient des déficiences auditives / visuelles, un retard neurocognitif, une déficience sensorielle de la douleur, une inscription antérieure et la discrétion du personnel clinique des urgences. Les mesures des résultats comprenaient l’échelle d’hétéro-évaluation comportementale (OSBD-R: Observational Scale of Behavioral Distress – Revised) (détresse) et l’échelle de visages (FPS-R: Faces Pain Scale-Revised) (douleur).
Résultats
Sur les 86 enfants recrutés (âge médian 9 ans, IQR 7,10) ; 55 % (47/86) étaient de sexe masculin, 9 % (7/82) étaient prématurés, 82 % (67/82) avaient une visite antérieure aux urgences, 31 % (25/82) avaient déjà été hospitalisés et 78 % (64/82) avaient déjà été insérés par voie intraveineuse. Quatre-vingt-seize pour cent (78/81) ont reçu une anesthésie topique avant l'insertion intraveineuse. Le score total de détresse OSBD-R était de 1,49 ± 2,36 (soins standard) contre 0,78 ± 1,32 (robot) (p < 0,05). Le score de douleur FPS-R était de 4 (IQR 2,6) (soins standard) contre 2 (IQR 0, 4) (robot) (p=0,13). L’anxiété parentale immédiatement après l’intervention était de 36,7 (11,1) (soins standard) contre 31,3 (8,5) (robot) (p=0,04). Les parents étaient plus satisfaits de la gestion de la douleur dans le groupe de distraction robotique (95 % vs 72 % très satisfaits) (p = 0,002).
Conclusions
La thérapie de distraction à base de robot humanoïde est associée à un impact positif modeste sur la détresse de l’enfant pour l’insertion intraveineuse pédiatrique, mais pas la douleur. Il peut être considéré comme un outil potentiel dans la boîte à outils des Services d’Urgences pour la réduction de la détresse associée à la douleur procédurale.
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Acknowledgements
This study was funded through a Support Platforms for Integrated Research (SPIR) Grant from the Women & Children’s Health Research Institute (WCHRI, Edmonton, Alberta, Canada), for which Dr. Samina Ali and Dr. Sarah Curtis are co-principal investigators (2014–2018). Dr. Hartling is supported by a Canada Research Chair in Knowledge Synthesis and Translation, and is a Distinguished Researcher with the Stollery Science Lab. Dr. Scott is supported by a Canada Research Chair in Knowledge Translation in Child Health, and is a Distinguished Researcher with the Stollery Science Lab.
Funding
Dr. Tanya Beran is the founder of RxRobots, a company that is the maker of the robot’s software used in this study. Our team purchased the robot at full price, with a Stollery Children’s Hospital Foundation Grant. Dr. Tanya Beran has not participated in data collection or statistical analysis.
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Dr. Tanya Beran is the founder of RxRobots, a company that is the maker of the robot’s software used in this study. Dr. Tanya Beran has not participated in data collection or statistical analysis.
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Ali, S., Manaloor, R., Ma, K. et al. A randomized trial of robot-based distraction to reduce children’s distress and pain during intravenous insertion in the emergency department. Can J Emerg Med 23, 85–93 (2021). https://doi.org/10.1007/s43678-020-00023-5
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DOI: https://doi.org/10.1007/s43678-020-00023-5