Sylvie Le May1,2, Argerie Tsimicalis3,4, Melanie Noel5, Pierre Rainville6, Christelle Khadra7, Ariane Ballard3, Estelle Guingo8, Casey Cotes-Turpin8, Sofia Addab4, Khadidja Chougui4,9, Maxime Francoeur1, Nicole Hung1,10, Mitchell Bernstein11, Stéphane Bouchard12, Stefan Parent13, Mathilde Hupin Debeurme13. 1. Research Center, CHU Sainte-Justine, Montreal, QC, Canada. 2. Faculty of Nursing, Université de Montréal, Montreal, QC, Canada. 3. Ingram School of Nursing, McGill University, Montreal, QC, Canada. 4. Shriners' Hospital for children in Montreal, Montreal, QC, Canada. 5. Department of Psychology, University of Calgary, Calgary, AB, Canada. 6. Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada. 7. Faculty of Medicine, McGill University, Montreal, QC, Canada. 8. UQAT Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada. 9. Department of Psychology, Université de Montréal, Montreal, QC, Canada. 10. Faculty of Medicine, Université de Montréal, Montreal, QC, Canada. 11. Division of Orthopaedic Surgery, McGill University Health Centre, Montreal, QC, Canada. 12. UQO Université du Québec en Outaouais, Saint-Jérôme, QC, Canada. 13. Department of Surgery, CHU Sainte-Justine, Montreal, QC, Canada.
Abstract
AIMS: To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures. DESIGN: Three-centre randomized clinical trial using a parallel design with two groups: experimental and control. METHODS: Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%. DISCUSSION: While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting. IMPACT: Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly. TRIAL REGISTRATION: NCT03680625, registered on clinicaltrials.gov.
RCT Entities:
AIMS: To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures. DESIGN: Three-centre randomized clinical trial using a parallel design with two groups: experimental and control. METHODS: Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%. DISCUSSION: While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting. IMPACT: Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly. TRIAL REGISTRATION: NCT03680625, registered on clinicaltrials.gov.
Authors: Reza Firoozabadi; Moamen Elhaddad; Sydney Drever; Maryam Soltani; Michael Githens; Conor P Kleweno; Sam R Sharar; David R Patterson; Hunter G Hoffman Journal: Front Virtual Real Date: 2020-12-14