Samina Ali1,2, Robin Manaloor3, Keon Ma3, Mithra Sivakumar4, Tanya Beran5, Shannon D Scott6, Ben Vandermeer4,7, Natasha Beirnes8, Timothy A D Graham9, Sarah Curtis4,10, Hsing Jou4, Lisa Hartling4,10,7. 1. Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada. sali@ualberta.ca. 2. Women and Children's Health Research Institute (WCHRI), Edmonton, AB, Canada. sali@ualberta.ca. 3. Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada. 4. Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, 3-583 Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada. 5. Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. 6. Faculty of Nursing, University of Alberta, Edmonton, AB, Canada. 7. Department of Pediatrics, Alberta Research Centre for Health Evidence, University of Alberta, Edmonton, AB, Canada. 8. Child Life Department, Stollery Children's Hospital, Edmonton, AB, Canada. 9. Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada. 10. Women and Children's Health Research Institute (WCHRI), Edmonton, AB, Canada.
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.
RCT Entities:
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.