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.

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.

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.

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.

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.