Distraction in the Emergency department using Virtual reality for INtravenous procedures in Children to Improve comfort (DEVINCI): a pilot pragmatic randomized controlled trial.

OBJECTIVES: Intravenous (IV) procedures cause pain and distress in the pediatric emergency department (ED). We studied the feasibility and acceptability of virtual reality distraction for patient comfort during intravenous procedures. METHODS: Children were randomized to a control (standard care) or intervention group (standard care + virtual reality). Thresholds for feasibility and acceptability (primary outcomes) were determined through a priori established criteria. The level of procedural pain (principal clinical outcome) and distress, as well as memory of pain at 24 h were collected and reported as medians (Q1, Q3) for each group. RESULTS: 63 patients were enrolled, with a high rate of recruitment (78.8%) and game completion (90.3%). Patients, parents and, healthcare providers reported high satisfaction levels. There were no serious adverse events. Five of the 30 patients (16.7%) exposed to virtual reality reported mild side effects. Self-reported procedural pain (verbal numerical rating scale: 3 (1, 6)/10 vs 3 (1, 5.5)/10, p = 0.75) was similar between groups. Further exploratory clinical measures were reported for the intervention and control groups, respectively: self-rated distress during the procedure (Child Fear Scale: 1 (0, 2)/4 vs 2 (0, 3)/4); distress evaluated by proxy during the procedure (Procedure Behavior Check List: 8 (8, 9)/40 vs 10 (8, 15)/40); memory of pain at 24 h (VNRS: 2 (1, 3)/10 vs 4 (2, 6.5)/10). CONCLUSION: The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED. Occasional mild, self-resolving side effects were observed in the intervention group. Self-reported pain during the procedure was similar between groups. CLINICALTRIALS. GOV IDENTIFIER: NCT03750578.

RéSUMé: OBJECTIFS: Les procédures intraveineuses (IV) causent de la douleur et de la détresse dans le service des urgences pédiatriques (ED). Nous avons étudié la faisabilité et l'acceptabilité de la distraction en réalité virtuelle pour le confort du patient lors des procédures intraveineuses. LES MéTHODES: Les enfants ont été randomisés dans un groupe de contrôle (soins standard) ou d'intervention (soins standard + réalité virtuelle). Les seuils de faisabilité et d'acceptabilité (résultats primaires) ont été déterminés au moyen de critères établis a priori. Le niveau de douleur procédurale (résultat clinique principal) et de détresse, ainsi que la mémoire de la douleur à 24 heures ont été recueillis et rapportés sous forme de médiane (Q1, Q3) pour chaque groupe. RéSULTATS: 63 patients ont été inscrits, avec un taux élevé de recrutement (78,8 %) et de complétion du jeu (90,3 %). Les patients, les parents et les prestataires de soins de santé ont déclaré des niveaux de satisfaction élevés. Il n'y a pas eu d'événements indésirables graves. Cinq des 30 patients (16,7 %) exposés à la réalité virtuelle ont signalé des effets secondaires légers. La douleur procédurale auto-déclarée (échelle d'évaluation numérique verbale : 3 (1, 6)/10 vs 3 (1, 5,5)/10, p = 0,75) était similaire entre les groupes. D'autres mesures cliniques exploratoires ont été signalées respectivement pour les groupes d'intervention et de contrôle : détresse auto-évaluée pendant la procédure (échelle de peur de l'enfant: 1 (0,2) / 4 vs 2 (0, 3) / 4); détresse évaluée par procuration au cours de la procédure (Procedure Behavior Check List: 8 (8, 9)/40 vs 10 (8, 15)/40) ; mémoire de la douleur à 24 heures (VNRS : 2 (1, 3)/10 vs 4 (2, 6,5)/10). CONCLUSION: L'ajout de la réalité virtuelle aux soins standard est faisable et acceptable pour la gestion de la douleur et de la détresse pendant les procédures IV dans l'urgence pédiatrique. Des effets secondaires occasionnels légers et auto-régulants ont été observés dans le groupe d'intervention. La douleur auto-déclarée pendant l'intervention était similaire entre les groupes.

Decreasing Pain and Fear in Medical Procedures with a Pediatric Population (DREAM): A Pilot Randomized Within-Subject Trial.

BACKGROUND: Many children with injuries, including burns and fractures, experience moderate to severe pain during medical procedures. Recent studies claim that nonpharmacologic pain management using virtual reality (VR) could distract children from procedural pain by engaging multiple senses. AIMS: The aims of this pilot randomized clinical trial were to assess the acceptability and feasibility of VR distraction in children with burns or fractures undergoing painful medical procedures, as well as the staff nurses, and assess the preliminary efficacy of VR distraction on pain intensity, pain-related fear, and subsequent recall of both. MATERIALS AND METHOD: A within-subject study design, in which participants served as their own control, was used. A total of 20 children from 7 to 17 years old with an injury were recruited at the surgical-trauma outpatient clinics of the Centre hospitalier universitaire Sainte-Justine (CHU Sainte-Justine). Each participant received both standard and experimental treatments through randomized order. Pain (numerical rating scale) and pain-related fear (Children's Fear Scale) measures were taken before the procedure and after each sequence, followed by a measure of children's (graphic rating scale) and nurses' acceptability of the intervention through their satisfaction level. Recall of pain intensity and pain-related fear were assessed 24 hours after the procedure. Wilcoxon signed-rank tests were used, with a significance level at 0.05. RESULTS: Results showed that VR distraction was an acceptable and feasible intervention for children and nurses of these outpatient clinics. Preliminary effects showed that, compared to standard of care, children participants reported a significant decrease in pain intensity (p = .023) and pain-related fear (p = .011) during VR as well as less recalled pain-related fear (p = .012) at 24 hours after the procedure. No side effects were reported. CONCLUSION: VR is a promising intervention with children undergoing painful procedures because it is immersive and engages multiple senses. It is a low-cost intervention well accepted by children and nursing staff at this clinical site and is easy to implement in daily practice for procedural pain management.

Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.

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.

Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial.

AIM: The aim of this study was to examine the effect of a water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment on pain in young children undergoing burn wound care in hydrotherapy. METHODS: This study was a prospective, within-subject crossover trial of 38 children aged 6 months to 7 years old (mean age=1.8 years old). Each hydrotherapy procedure was divided into two equivalent wound care segments (No hybrid VR during one segment vs. Hybrid VR during the other segment, treatment order was randomized). Pain was measured using the 0-10 FLACC (Face, Legs, Activity, Cry Consolability scale) and the 0-10 NRS-obs (Numerical Rating Scale-obs). RESULTS: Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p=0.026) and significantly increased patients' comfort levels (p=0.002). Patients' pain levels rated by the nurses using the NRS-obs were non-significant between both groups (p=0.135). No side effects were reported. CONCLUSION: Projector-Based Hybrid VR helped in reducing the pain related to hydrotherapy procedures in young children with burn wound injuries. This is the first study using virtual reality distraction with young children, and our findings are especially important because a large percentage of pediatric burn patients are very young. Additional research and development are recommended. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02986464, registered on June 12, 2016.