Effects of a Virtual Reality Game on Children's Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Dental fear and anxiety (DFA) is a condition that affects approximately one-quarter of children and adolescents. It is a significant cause for pediatric patients to avoid dental care later in adulthood. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely and consider alternative pharmacological treatment options. Virtual reality (VR) use during dental care, providing an immersive experience through sensory stimuli, is potentially an additional nonpharmacologic tool to better manage DFA in children with special health care needs (SHCN) undergoing dental procedures. OBJECTIVE: This pilot study aims to assess the feasibility and acceptability of VR immersion as a tool to reduce DFA in pediatric special needs patients undergoing dental procedures. The study also aims to gain insight on parent and health care provider perspectives on the use of VR during dental appointments. METHODS: This pilot randomized controlled trial study will follow a parallel design including 2 groups: a control group (clinic's standard care using a wall TV) and an experimental group (using a VR game). We will randomize 20 participants to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The primary outcome will be patient recruitment rates and completion rates of planned procedures. DFA in children will be assessed using both an observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale and physiological assessments using parameters such as change in heart rate and levels of salivary alpha-amylase as a stress biomarker before and 10 minutes after the procedure. Sociodemographic characteristics, measures of the levels of parent and health care professional satisfaction, occurrence of side effects, and any deviation from normal procedure length will also be collected. Descriptive statistics, nonparametric tests, and effect sizes will be used for demographic and clinical variables and to present parent and health care professional satisfaction levels as well as procedural time. RESULTS: This study will be conducted from May 2023 to May 2024, with results expected to be available in December 2024. CONCLUSIONS: The pilot study will provide insight on the feasibility and acceptability of VR use in clinical dentistry to reduce DFA for pediatric patients with SHCN. This study will guide future research on VR use in pediatric dentistry and can serve as a framework for a larger randomized clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05898100; https://classic.clinicaltrials.gov/ct2/show/NCT05898100. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49956.

Effects of pharmacogenetic profiles on pediatric pain relief and adverse events with ibuprofen and oxycodone.

Introduction: Individual genetic variation may influence clinical effects for pain medications. Effects of CYP2C9, CYP3A4, and CYP2D6 polymorphisms on clinical effectiveness and safety for ibuprofen and oxycodone were studied. Objective: Primary objectives were to AU2 evaluate if allelic variations would affect clinical effectiveness and adverse events (AEs) occurrence. Methods: This pragmatic prospective, observational cohort included children aged 4 to 16 years who were seen in a pediatric emergency department with an acute fracture and prescribed ibuprofen or oxycodone for at-home pain management. Saliva samples were obtained for genotyping of allelic variants, and daily telephone follow-up was conducted for 3 days. Pain was measured using the Faces Pain Scale-Revised. Results: We included 210 children (n = 140 ibuprofen and n = 70 oxycodone); mean age was 11.1 (±SD 3.5) years, 33.8% were female. Median pain reduction on day 1 was similar between groups [ibuprofen 4 (IQR 2,4) and oxycodone 4 (IQR 2,6), P = 0.69]. Over the 3 days, the oxycodone group experienced more AE than the ibuprofen group (78.3% vs 53.2%, P < 0.001). Those with a CYP2C9*2 reduced function allele experienced less adverse events with ibuprofen compared with those with a normal functioning allele CYP2C9*1 (P = 0.003). Neither CYP3A4 variants nor CYP2D6 phenotype classification affected clinical effect or AE. Conclusion: Although pain relief was similar, children receiving oxycodone experienced more AE, overall, than those receiving ibuprofen. For children receiving ibuprofen or oxycodone, pain relief was not affected by genetic variations in CYP2C9 or CYP3A4/CYP2D6, respectively. For children receiving ibuprofen, the presence of CYP2C9*2 was associated with less adverse events.

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery.

Presurgical anxiety is very common and is often treated with sedatives. Minimizing or avoiding sedation reduces the risk of sedation-related adverse events. Reducing sedation can increase early cognitive recovery and reduce time to discharge after surgery. The current case study is the first to explore the use of interactive eye-tracked VR as a nonpharmacologic anxiolytic customized for physically immobilized presurgery patients. Method: A 44-year-old female patient presenting for gallbladder surgery participated. Using a within-subject repeated measures design (treatment order randomized), the participant received no VR during one portion of her preoperative wait and interactive eye-tracked virtual reality during an equivalent portion of time in the presurgery room. After each condition (no VR vs. VR), the participant provided subjective 0-10 ratings and state-trait short form Y anxiety measures of the amount of anxiety and fear she experienced during that condition. Results: As predicted, compared to treatment as usual (no VR), the patient reported having 67% lower presurgical anxiety during VR. She also experienced "strong fear" (8 out of 10) during no VR vs. "no fear" (0 out of 10) during VR. She reported a strong sense of presence during VR and zero nausea. She liked VR, she had fun during VR, and she recommended VR to future patients during pre-op. Interactive VR distraction with eye tracking was an effective nonpharmacologic technique for reducing anticipatory fear and anxiety prior to surgery. The results add to existing evidence that supports the use of VR in perioperative settings. VR technology has recently become affordable and more user friendly, increasing the potential for widespread dissemination into medical practice. Although case studies are scientifically inconclusive by nature, they help identify new directions for future larger, carefully controlled studies. VR sedation is a promising non-drug fear and anxiety management technique meriting further investigation.

Topical anesthetics for needle-related pain in adults and children (TOPIC): a mini-review.

Purpose: Healthcare professionals (HCP) perform various needle procedures that can be distressing and painful for children and adults. Even though many strategies have been proven effective in reducing distress and pain, topical anesthetic use before needle procedures is uncommon. However, there are limited studies in the existing literature comparing specifically liposomal lidocaine and tetracaine hydrochloride topical creams. Source: This systematic review analyzed studies on the use of two anesthetic creams, Liposomal Lidocaine (Maxilene®) and Tetracaine hydrochloride (Ametop™), in children and adults undergoing a needle-related procedure. Databases searched: PubMed, CINAHL, ClinicalTrials. Only randomized controlled trials (RCT) and Controlled Clinical Trials (CCT) studies were included. Cochrane Collaboration's Risk of Bias assessment tool was used. Strictly minimally invasive procedures were included to standardize different skin needle interventions. Principal findings: Only one study with 60 participants was available to be included in this review. No statistically significant difference was found in the mean pain score among both interventions. The outcomes of self-reported distress during cannulation and on HCP satisfaction were not reported. However, physiological characteristics associated with stress/anxiety and on cannulation success rate were reported and did not show statistical significance. Conclusion: Little to no evidence regarding the most efficient cream between liposomal lidocaine and tetracaine hydrochloride for pain management during needle-related procedures was found. Further studies, particularly RCT with larger sample sizes and standardized outcome measures, are needed to confirm the relative efficacy of either anesthetic cream.

Reliability and validity of physical examination tests for the assessment of ankle instability.

INTRODUCTION: Clinicians rely on certain physical examination tests to diagnose and potentially grade ankle sprains and ankle instability. Diagnostic error and inaccurate prognosis may have important repercussions for clinical decision-making and patient outcomes. Therefore, it is important to recognize the diagnostic value of orthopaedic tests through understanding the reliability and validity of these tests. OBJECTIVE: To systematically review and report evidence on the reliability and validity of orthopaedic tests for the diagnosis of ankle sprains and instability. METHODS: PubMed, CINAHL, Scopus, and Cochrane databases were searched from inception to December 2021. In addition, the reference list of included studies, located systematic reviews, and orthopaedic textbooks were searched. All articles reporting reliability or validity of physical examination or orthopaedic tests to diagnose ankle instability or sprains were included. Methodological quality of the reliability and the validity studies was assessed with The Quality Appraisal for Reliability studies checklist and the Quality Assessment of Diagnostic Accuracy Studies-2 respectively. We identified the number of times the orthopaedic test was investigated and the validity and/or reliability of each test. RESULTS: Overall, sixteen studies were included. Three studies assessed reliability, eight assessed validity, and five evaluated both. Overall, fifteen tests were evaluated, none demonstrated robust reliability and validity scores. The anterolateral talar palpation test reported the highest diagnostic accuracy. Further, the anterior drawer test, the anterolateral talar palpation, the reverse anterior lateral drawer test, and palpation of the anterior talofibular ligament reported the highest sensitivity. The highest specificity was attributed to the anterior drawer test, the anterolateral drawer test, the reverse anterior lateral drawer test, tenderness on palpation of the proximal fibular, and the squeeze test. CONCLUSION: Overall, the diagnostic accuracy, reliability, and validity of physical examination tests for the assessment of ankle instability were limited. Physical examination tests should not be used in isolation, but rather in combination with the clinical history to diagnose an ankle sprain. Preliminary evidence suggests that the overall validity of physical examination for the ankle may be better if conducted five days after the injury rather than within 48 h of injury.

Quantifying the intensity of adverse events with ibuprofen and oxycodone: an observational cohort study.

OBJECTIVE: To quantify the frequency and intensity of adverse events (AEs), commonly known as side effects, experienced by children receiving either ibuprofen or oxycodone for pain management following an acute fracture. Secondary objectives were to quantify functional outcome impairment and describe demographic and clinical characteristics associated with AEs. DESIGN: Observational cohort study. SETTING: Paediatric emergency department. PATIENTS: Patients (n=240) aged 4-16 years diagnosed with an acute fracture. INTERVENTION: Prescribed either ibuprofen (n=179) or oxycodone (n=61) for pain. MAIN OUTCOME MEASURES: Families were called for the first 3 days after discharge to report the presence and intensity of AEs and their child's functional outcomes (ability to eat, sleep, play or attend school). RESULTS: On day 1, children using oxycodone were more likely to report any AE (χ2 1=13.5, p<0.001), nausea (χ2 1=17.0, p<0.001), vomiting (χ2 1=11.2, p<0.001), drowsiness (χ2 1=13.7,p<0.001), constipation (χ2 1=8.9, p=0.003) and dizziness (χ2 1=19.1, p<0.001), compared with those using ibuprofen. Children receiving oxycodone reported greater severity of abdominal pain (oxycodone: mean 5.4 SD 3.1; ibuprofen mean 2.5 SD 1.4, F1 13=6.5, p=0.02) on day 1 and worse intensity of constipation (oxycodone: mean 4.9 SD 2.1; ibuprofen mean 3.2 SD 2.2, F1 33=4.5, p=0.04) over all 3 days. Use of oxycodone was associated with an increased odds of experiencing an AE on day 1 (OR=1.31 (95% CI 1.13 to 1.52)). Higher pain scores (OR=1.50 (95% CI 1.12 to 2.01)), lower extremity fracture (OR=1.25 (95% CI 1.07 to 1.47)) and undergoing ED sedation (OR=1.16 (95% CI 1.01 to 1.34)) were associated with missing school. Higher pain scores (OR=1.50 (95% CI 1.14 to 1.97)) and lower extremity fractures (OR=1.23 (95% CI 1.07 to 1.43)) were also associated with less play. CONCLUSIONS: Oxycodone is associated with more frequent AEs overall, higher intensity gastrointestinal AEs and greater functional limitations compared with ibuprofen. Lower extremity fractures cause more functional limitations than upper extremity fractures. Clinicians should consider these differences when providing fracture pain care for children.

The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial.

BACKGROUND: It is known that magnetic resonance imaging (MRI) procedures generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI procedure to be repeated with sedation. Few studies seem to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for MRI scans and how to identify which children are more responsive. OBJECTIVE: The aims of this study are 3-fold: develop an algorithm of predictability based on biofeedback, address feasibility and acceptability of preprocedural IVR game preparation for anxiety management during MRI procedures, and examine the efficacy of IVR game preparation compared with usual care for the management of procedural anxiety during MRI scans. METHODS: This study will have 2 phases. We will first conduct a field test with 10 participants aged 7 to 17 years to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. After the field test, a randomized controlled trial will be completed using a parallel design with 2 groups: an experimental group (preprocedural IVR game preparation) and a usual care group (standard care as per the radiology department's protocol) in an equal ratio of 49 participants per group for 98 participants. Recruitment will be carried out at a hospital in Quebec, Canada. The experimental group will receive a preprocedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI scan. Participants will complete a questionnaire to assess the acceptability, feasibility, and incidence of side effects related to the intervention and the biofeedback device. Data collected will include sociodemographic and clinical characteristics as well as measures of procedure-related anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (score 1-3) and the Children's Fear Scale (score 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature, and muscle tension. Measures of the level of satisfaction of health care professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a Cronbach α significance level of .05. RESULTS: As of May 10, 2022, no participant was enrolled in the clinical trial. The data collection time frame is projected to be between April 1, 2022, and March 31, 2023. Findings will be disseminated through peer-reviewed publications. CONCLUSIONS: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI procedure. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a nonpharmacological therapeutic modality for anxiety management in children scheduled for an MRI scan. TRIAL REGISTRATION: ClinicalTrials.gov NCT04988516; https://clinicaltrials.gov/ct2/show/NCT04988516. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/30616.

Developing and Pilot Testing E-Learning Training for Pediatric Nursing Burn Care.

Background Nurses caring for pediatric patients who have burns need to be properly trained to provide optimal care. The aims of this pilot study were to (1) develop a pediatric nursing burn care e-learning training for novice nurses; (2) assess the feasibility and acceptability of this educational intervention; and (3) evaluate the preliminary effects of this intervention on novice nurses' knowledge of pediatric nursing burn care. Method A quasi-experimental, one-group, pre-test-posttest design was used. Results Feasibility was achieved because all of the participants completed the study. A significant difference was observed in the mean knowledge level of the novice nurses from before training to after training (87.7% ± 8.7% vs. 58.6% ± 14.5%; p < .001). The novice nurses' had a mean satisfaction of 95.5% after the intervention. Conclusion This new, evidence-based pediatric nursing burn care e-learning training appeared to be feasible. The novice nurses found it to be satisfactory, and it improved their knowledge regarding pediatric burn care. [J Contin Educ Nurs. 2022;53(5):232-240.].

Development of a model of interprofessional support interventions to enhance brace adherence in adolescents with idiopathic scoliosis: a qualitative study.

PURPOSE: Brace treatment for adolescent idiopathic scoliosis is recognized as effective if the brace is worn as prescribed (20 to 23 hrs/day). Because of its negative biopsychosocial impact on adolescent patients' quality of life, brace adherence is a common problem (average bracewear of 12 hrs/day). The purpose of this paper is to develop an interprofessional support intervention model to enhance brace adherence in adolescents with scoliosis. METHODS: We enrolled 9 health professionals working with braced patients to participate in individual interviews. Interview guides were built following the Information-Motivation-Strategy Model (DiMatteo et al., Health Psychol Rev 6:74-91, 2012) and the Interprofessional Care Competency Framework (Education UoTCfI, Toronto Acad Health Sci Network, 2017). Thematic analysis was performed to identify the most relevant concepts for designing the intervention model. A panel of 5 clinical experts was recruited to review and validate the intervention model. RESULTS: Participants suggested educational, motivational, functional, psychological and interprofessional teamwork strategies to improve the support provided to patients and parents and potentially increase brace adherence. Using the emerging themes and their relationships, we designed an Interprofessional Adherence Support (IPAS) intervention model that identifies the actors, activities, structure and intended impacts of the intervention. According to the expert panel, the IPAS model is highly relevant to respond to the brace adherence problem and has potential for implementation in practice. CONCLUSION: We designed an interprofessional support intervention model based on professional perspectives in response to the brace adherence problem in adolescents with scoliosis. Plans for implementation of the IPAS model at our scoliosis clinic are under development and considered essential for improving brace treatment outcomes.

Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review.

AIMS: This integrative review aimed to identify, analyse and synthesise studies investigating the clinical efficacy of virtual reality (VR) distraction for children undergoing varying painful and anxiety-inducing medical procedures across different hospital settings and to identify implications for research and clinical practice. BACKGROUND: Virtual reality has been leveraged as a distraction tool in the healthcare setting to help patients manage procedural pain and anxiety. Initial studies in the burn wound care setting using VR as a non-pharmacological analgesia led to the use of VR during other medical procedures. DESIGN: An integrative review of the literature was conducted following the PRISMA guidelines across four electronic databases. Published studies between 2000 and 2020 investigating the clinical efficacy of VR in managing paediatric procedural pain or anxiety were included for review. RESULTS: Reviewed studies collectively included 2,174 patients aged 6 months-18 years used VR during burn wound care, post-burn physiotherapy, dental, needle-related and other procedures. Additionally, ten studies included samples with adults, for which paediatric data could not be isolated (n = 507). Overall, studies supported the efficacy of VR in managing procedural pain and anxiety in the paediatric setting. CONCLUSION: Virtual reality is redefining pain management by immersing children in a virtual world, reducing pain and anxiety at the hospital. A notable gap was the neglected use of VR in children with chronic conditions receiving orthopaedic procedures as part of their standard care. RELEVANCE TO CLINICAL PRACTICE: Ultimately, VR distraction will reduce the fear associated with medical interventions, preventing increased pain sensitivity, exacerbated anxiety and healthcare avoidance in adulthood. Nurses will play an important role in ensuring the smooth integration of VR in clinical practice by championing the technology and transferring evidence-based methods for VR use.

Virtual reality mobility for burn patients (VR-MOBILE): A within-subject-controlled trial protocol.

In the acute phase, burn patients undergo several painful procedures. Pediatric burn care procedures conducted in hydrotherapy have been known to generate severe pain intensity and moderate to high levels of anxiety. Hydrotherapy treatments are done with the use of opioids and benzodiazepines for pain and anxiety. Unfortunately, nonpharmacological methods are rarely combined with pharmacological treatments despite evidence showing that distraction can serve as an effective method for pain management and can potentially decrease analgesic requirements in other painful medical procedures. Virtual reality (VR) is a method that uses distraction to interact within a virtual environment. The use of VR is promising for pain reduction in varying settings. Considering the lack of optimal pain and anxiety management during burn wound care and the positive effect of an immersive distraction for painful procedures, using VR for burn wound care procedures may show promising results. This is a within-subject randomized controlled trial design in which each participant will serve as his/her own control. A minimum of 20 participants, aged 7 to 17 years old undergoing a burn care session, will receive both standard and experimental treatments during the same session in a randomized order. The experimental treatment will consist of combining VR distraction using the video game Dreamland® to the current standard pharmacological care as per unit protocol. The control group will only receive the unit's standard pharmacological care. The mean difference in both pain intensity scores and in anxiety between the two different sequences will be the primary outcomes of this study. This study evaluates the effect of VR on burn wound care. If results from this study show a positive effect of VR compared to standard care, this protocol may provide guidance on how to implement this type of immersive care as part of the tools available for distraction of painful procedures for acute burn victims.

Nurturing and quiet intervention (NeuroN-QI) on preterm infants' neurodevelopment and maternal stress and anxiety: A pilot randomized clinical trial protocol.

OBJECTIVES: Primary objective of this pilot study is to evaluate the feasibility and acceptability of the NeuroN-QI and the study procedures. Secondary objectives are to assess the feasibility and acceptability of the NeuroN-QI by the nurses, assess the nurses' training needs about the components of the NeuroN-QI, and estimate the preliminary effects of the NeuroN-QI on infants' neurodevelopment as well as maternal stress and anxiety at infants' 36 weeks of gestational age. DESIGN: A two-group pilot parallel randomized clinical trial stratified by center. METHODS: The pilot study will be conducted in two neonatal intensive care units (NICUs). A sample of 24 mother-infant dyads born between 26 and 316/7 gestational age will be randomized into an experimental or control group. Fifty nurses will be recruited. The NeuroN-QI consists of four 2-hour skin-to-skin contact sessions/week with a 15-minute auditory stimulation by mothers with controlled ambient levels of light and noise. A 1-hour quiet period will follow where infants will rest in their incubator/crib with their mother's milk for olfactory stimulation and where the light and noise control will be continued. In the control group, mother-infant dyads will do four skin-to-skin contacts per week and receive standard care. Acceptability and feasibility of the NeuroN-QI in addition to maternal stress and anxiety will be measured through questionnaires, while infants' neurodevelopment will be assessed with Assessment of Preterm Infant Behaviour and General Movement Assessment. CONCLUSIONS: This pilot trial will address knowledge gaps and generate evidence in neonatal care by evaluating the feasibility and acceptability of a multi-component developmental care intervention. IMPACT: This project is an innovative step towards optimizing the neurodevelopmental trajectory of infants in NICUs and consequently promoting their long-term health outcomes. TRIAL REGISTRATION: NCT04593095.

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.

Risk factors for severe opioid-induced respiratory depression in hospitalized adults: A case-control study.

Background: Opioids are commonly prescribed to hospitalized adults to promote adequate pain relief, yet they can cause potentially fatal respiratory depression. Aim: The aim of this study was to examine the risk factors for the development of severe opioid-induced respiratory depression (OIRD) in hospitalized adults to ensure adequate monitoring of high-risk patients. Methods: A retrospective case-control study was conducted using data from the medical records of a university-affiliated hospital in Canada. Cases were eligible if they were adults (≥18 years old) and received opioid analgesia within 24 h of naloxone administration for respiratory depression. Controls had the same eligibility criteria, except for respiratory depression and naloxone administration. The case-control ratio was 1:1, and they were matched based on sex, type of unit, opioid molecule and the presence/absence of medication errors. Results: A total of 133 cases and 133 controls were included. Following cumulative risk factor analysis, renal failure (odds ratio [OR] = 2.176, 95% confidence interval [CI], 1.021-4.640, P = 0.044), the first 24 h of opioid administration (OR = 1.899, 95% CI, 1.090-3.309, P = 0.024), concomitant central nervous system (CNS) depressants (OR = 1.785, 95% CI, 1.023-3.113, P = 0.041), and increasing age (OR = 1.019, 95% CI, 1.002-1.035, P = 0.028) were positively associated with severe OIRD. Conclusions: Some adult hospitalized patients were at higher risk of experiencing severe OIRD, such as those with renal failure, those in their first 24 h of opioid administration, those receiving CNS depressants in addition to opioids, and those with an advanced age. These results will assist with the screening of patients at higher risk for severe OIRD, which is key to implementing appropriate monitoring and enhancing the safety of opioid use in hospital settings.

Contexte: Les opioïdes sont couramment prescrits aux adultes hospitalisés pour favoriser un soulagement adéquat de la douleur, mais ils peuvent provoquer une dépression respiratoire potentiellement mortelle.Objectif: Examiner les facteurs de risque du développement d'une dépression respiratoire sévère induite par un opioïde chez les adultes hospitalisés afin d'assurer un suivi adéquat des patients à haut risque.Méthodes: Une étude rétrospective cas - témoins a été menée en utilisant les données des dossiers médicaux d'un hôpital universitaire au Canada. Les cas étaient admissibles s'ils étaient adultes (≥ 18 ans) et avaient reçu une analgésie opioïde dans les 24 heures suivant l'administration de naloxone pour une dépression respiratoire. Les critères d'admissibilité étaient les mêmes pour les témoins, à l'exception de la dépression respiratoire et de l'administration de naloxone. Le rapport cas/témoins était de 1:1 et ceux-ci étaient appariés en fonction du sexe, du type d'unité, de la molécule opioïde et de la présence ou absence d'erreurs de médication.Résultats: Un total de 133 cas et 133 témoins ont été inclus. Après analyse des facteurs de risque cumulés, l'insuffisance rénale (RC = 2,176, IC à 95 % : 1,021 - 4,640, p = 0,044), les premières 24 heures d'administration d'opioïdes (RC = 1,899, IC à 95 % : 1,090 -3, 309, p = .024), les dépresseurs du SNC concomitants (RC = 1,785, IC à 95 % : 1,023-3,113, p = 0,041) et l'augmentation de l'âge par âge avancé (RC = 1,019, IC à 95 % : 1,002 - 1,035, p = 0,028) ont été positivement associés à des dépressions respiratoires sévères induites par un opioïde.Conclusions: Certains patients adultes hospitalisés présentaient un risque plus élevé de souffrir d'une dépression respiratoire sévère induite par un opioïde, notamment les personnes souffrant d'insuffisance rénale, celles à qui un opoïde a été administré dans les dernières 24 heures, celles qui ont reçu ds dépresseurs du SNC en plus d'un opioïde et celles qui étaient plus âgées. Ces résultats permettront d'identifier les patients à haut risque de souffrir d'une dépression respiratoire sévère induite par un opioïde, ce qui est essentiel pour mettre en place un suivi approprié et améliorer la sécurité de l'utilisation des opioïdes en milieu hospitalier.

Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis.

OBJECTIVE: This systematic review and meta-analysis examined the effectiveness of the Buzzy device combining cold and vibration for needle-related procedural pain in children. MATERIALS AND METHODS: Databases search was conducted from inception to December 2017 to identify randomized controlled trials using the Buzzy device for pain management in children undergoing needle-related procedures. Selection of studies, data extraction, and assessment of risk of bias and quality of evidence were independently performed by 2 reviewers. Quantitative and qualitative analyses were conducted. RESULTS: A total of 9 studies involving 1138 participants aged between 3 and 18 years old were included in the systematic review and 7 were suitable for meta-analysis. The meta-analysis compared the Buzzy device with a no-treatment comparator and the effect of the device was significant in reducing self-report procedural pain (standardized mean difference [SMD]: -1.11; 95% confidence interval [CI]: -1.52 to -0.70; P<0.0001), parent-reported procedural pain (SMD: -0.94; 95% CI: -1.62 to -0.27; P=0.006), observer-report procedural pain (SMD: -1.19; 95% CI: -1.90 to -0.47; P=0.001), observer-reported procedural anxiety (SMD -1.37; 95% CI: -1.77 to -0.96; P<0.00001), and parent-reported procedural anxiety (SMD -1.36; 95% CI: -2.11 to -0.61; P=0.0004). There was no significant difference for the success of the procedure at first attempt and the occurrence of adverse events. DISCUSSION: The Buzzy device seems to be a promising intervention for procedural pain management in children. However, the comparative effect is uncertain due to the presence of significant heterogeneity and very low-quality evidence. There is a need to improve the methodological quality and rigor in the design of future trials to conclude to the efficacy of the Buzzy device.

External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol.

INTRODUCTION: Needle-related procedures are considered as the most important source of pain and distress in children in hospital settings. Considering the physiological and psychological consequences that could result from these procedures, management of pain and distress through pharmacological and non-pharmacological methods is essential. Therefore, it is important to have interventions that are rapid, easy-to-use and likely to be translated into clinical practice for routine use. The aim of this study will be to determine whether a device combining cold and vibration (Buzzy) is non-inferior to a topical anaesthetic (liposomal lidocaine 4% cream) for pain management of children undergoing needle-related procedures in the emergency department. METHODS AND ANALYSIS: This study will be a randomised controlled non-inferiority trial comparing the Buzzy device to liposomal lidocaine 4% cream for needle-related pain management. A total of 346 participants will be randomly assigned in a 1:1 ratio to one of the two study groups. The primary outcome will be the mean difference in pain intensity between groups during needle-related procedures. A non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. A Non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. The secondary outcomes will be the level of distress during the procedure, the success of the procedure at first attempt, the occurrence of adverse events, the satisfaction of both interventions and the memory of pain 24 hours after the procedure. The primary outcome will be assessed for non-inferiority and the secondary outcomes for superiority. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the institutional review board of the study setting. Findings of this trial will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02616419.