Pilot Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care During Pediatric Laceration Repair.
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ABSTRACT:
SUBMITTER: Goldman RD
PROVIDER: S-EPMC8099939 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
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Pilot Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care During Pediatric Laceration Repair.
Goldman Ran D RD Behboudi Amir A
Journal of child & adolescent trauma 20210326 2
Virtual reality (VR) is an emerging immersive technology with initial documentation of reduction in anxiety and pain when used by children in the hospital setting. The objective of this study was to compare VR to standard of care (SOC) in a pediatric Emergency Department (ED) for pain management and anxiety among children needing a laceration repair procedure. We conducted a prospective randomized controlled trial in a tertiary pediatric ED (NCT03681717) with children 6-16 years of age going thr ...[more]
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Project description:BackgroundVirtual reality (VR) has shown promise in reducing children's pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive.ObjectiveThe primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department.MethodsThis stratified, randomized, controlled pilot trial compared coping and distress between child life-supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms.ResultsOverall recruitment was 93% (66/71), VR withdrawal rate was 27% (4/15), and of the completed procedures, 100% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37).ConclusionsReal-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children's coping during venipuncture or other related procedures.Trial registrationClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176.
| S-EPMC8367183 | biostudies-literature
Project description:ImportanceIt is unknown whether smartphone-based virtual reality (VR) games are effective in reducing pain among pediatric patients in real-world burn clinics.ObjectiveTo evaluate the efficacy of a smartphone VR game on dressing pain among pediatric patients with burns.Design, setting, and participantsThis randomized clinical trial included children aged 6 to 17 years who seen in the outpatient clinic of a large American Burn Association-verified pediatric burn center and level I pediatric trauma center between December 30, 2016, and January 23, 2019. Speaking English as their primary language was an inclusion criterion. Intention-to-treat data analyses were conducted from December 2019 to March 2020.InterventionsActive VR participants played a VR game; passive VR participants were immersed in the same VR environment without interactions. Both groups were compared with a standard care group. One researcher administered VR and observed pain while another researcher administered a posttrial survey that measured the child's perceived pain and VR experience. Nurses were asked to report the clinical utility.Main outcomes and measuresPatients self-reported pain using a visual analog scale (VAS; range, 0-100). A researcher observed patient pain based on the Face, Legs, Activity, Cry, and Consolability-Revised (FLACC-R) scale. Nurses were asked to report VR helpfulness (range, 0-100; higher scores indicate more helpful) and ease of use (range, 0-100; higher scores indicate easier to use).ResultsA total of 90 children (45 [50%] girls, mean age, 11.3 years [95% CI, 10.6-12.0 years]; 51 [57%] White children) participated. Most children had second-degree burns (81 [90%]). Participants in the active VR group had significantly lower reported overall pain (VAS score, 24.9 [95% CI, 12.2-37.6]) compared with participants in the standard care control group (VAS score, 47.1 [95% CI, 32.1-62.2]; P = .02). The active VR group also had a lower worst pain score (VAS score, 27.4 [95% CI, 14.7-40.1]) than both the passive VR group (VAS score, 47.9 [95% CI, 31.8-63.9]; P = .04) and the standard care group (VAS score, 48.8 [95% CI, 31.1-64.4]; P = .03). Simulator sickness scores (range, 0-60; lower scores indicate less sickness) were similar for active VR (19.3 [95% CI, 17.5-21.1]) and passive VR groups (19.5 [95% CI, 17.6-21.5]). Nurses also reported that the VR games could be easily implemented in clinics (helpfulness, active VR: 84.2; 95% CI, 74.5-93.8; passive VR: 76.9; 95% CI, 65.2-88.7; ease of use, active VR: 94.8, 95% CI, 91.8-97.8; passive VR: 96.0, 95% CI, 92.9-99.1).Conclusions and relevanceIn this study, a smartphone VR game was effective in reducing patient self-reported pain during burn dressing changes, suggesting that VR may be an effective method for managing pediatric burn pain.Trial registrationClinicalTrials.gov Identifier: NCT04544631.
| S-EPMC8218073 | biostudies-literature
Project description:Children must often endure painful procedures as part of their treatment for various medical conditions. Those with chronic pain endure frequent or constant discomfort in their daily lives, sometimes severely limiting their physical capacities. With the advent of affordable consumer-grade equipment, clinicians have access to a promising and engaging intervention for pediatric pain, both acute and chronic. In addition to providing relief from acute and procedural pain, virtual reality (VR) may also help to provide a corrective psychological and physiological environment to facilitate rehabilitation for pediatric patients suffering from chronic pain. The special qualities of VR such as presence, interactivity, customization, social interaction, and embodiment allow it to be accepted by children and adolescents and incorporated successfully into their existing medical therapies. However, the powerful and transformative nature of many VR experiences may also pose some risks and should be utilized with caution. In this paper, we review recent literature in pediatric virtual reality for procedural pain and anxiety, acute and chronic pain, and some rehabilitation applications. We also discuss the practical considerations of using VR in pediatric care, and offer specific suggestions and information for clinicians wishing to adopt these engaging therapies into their daily clinical practice.
| S-EPMC5532544 | biostudies-other
Project description:Aims and objectivesTo determine the effect of immersive virtual reality (VR) on perceived pain and fear in children during vaccination and parental satisfaction with the procedure.BackgroundVirtual reality can reduce the perception of pain by children but only three studies have analysed its use during vaccination to date; these had small sample sizes and imperfect methodological designs.DesignA randomised controlled clinical trial.MethodsOne hundred and sixty participants from the Tres Forques Health Center were randomly assigned to the intervention group (IG) (n = 82) in which distraction with immersive VR was used during the vaccination, while standard distraction techniques were used for the control group (n = 80). The primary outcome was pain (Wong-Baker FACES). Secondary outcomes included (Children's Fear Scale) and parental satisfaction with the vaccination procedure. Chi-squared tests were used for qualitative variables, relationships between quantitative variables were tested with Spearman correlations, and Mann-Whitney U- or Student t-tests were employed to assess the relationship between quantitative and qualitative variables.ResultsCompared to the controls, the children in the IG reported significantly less pain and fear, while parental satisfaction was significantly higher. Reported pain and fear did not differ according to the sex of the patient. Child age was not linked to fear but was related to pain: the younger the patient, the greater the pain they described.ConclusionsImmersive VR effectively controlled pain and fear in children during vaccination and increased parent satisfaction with the vaccination process. Patient sex did not influence the level of pain and fear but age did.Relevance to clinical practiceImproving vaccination experiences can reduce perceived pain and fear in children and increase parent satisfaction, thereby enhancing vaccination schedule adherence and improving group immunity.Reporting methodThe CONSORT Statement for non-pharmacological randomised clinical trials were followed.
| S-EPMC11808414 | biostudies-literature
Project description:Background: Music therapy (MT) and virtual reality (VR) have shown favorable patient-reported outcomes during serious illness. Objectives: To evaluate implementation measures of feasibility, usability, and acceptability of a VR-based MT intervention. Design: A pilot implementation study of a two-day VR-MT intervention using mixed methods. Patients created a personalized soundtrack with a music therapist, and then paired the soundtrack with a 360° VR environment. Setting/Subjects: Hospitalized patients with palliative care needs. Results: Of 23 patients (ages 20-74 years, 52% women), 17 completed the intervention, including 39% during an intensive care unit stay. Participants scored usability above average. For satisfaction, 53% chose the highest rating. Most participants spoke favorably of VR-MT, describing pleasant emotional and physical responses. Participants provided feedback on length, frequency of use, VR options, and timing of delivery. Conclusion: This VR-MT intervention was feasible, usable, and acceptable for hospitalized palliative care patients. Further study will test VR-MT outcomes.
| S-EPMC8064967 | biostudies-literature
Project description:ObjectiveThe purpose of this pilot study was to evaluate the safety and use of a nature-based virtual reality (VR) experience among health care providers (HCP) during a pandemic.MethodsTwenty-four frontline HCP participated in this crossover pilot where the viewing order of the experiences were randomized. All participants attended in-person consent, baseline, and end-of-study visits. The intervention consisted of viewing 2 nature-based scenes ("walk in the woods" and "forest of focus") through 3-D VR and with computer 4K graphic imagery. Randomization took place with regards to the viewing order (VR vs 4K computer video, scene 1 and 2). Outcomes measured were safety, acceptability and changes in intensity of anxiety feelings, resilience, emotional distress, cognitive function, and self-efficacy.ResultsAmong the 26 HCP expressing interest in the study, 24 enrolled in this study. The majority were male (58.3%), white (66.7%) and of an average age of 46.3 ± 10.5 years (standard deviation (SD)). End of the study survey showed that almost all participants (96%) would participate in the study again and recommend it to others. Twenty-three of the 24 participants also felt relaxed after seeing the imagery. With respect to anxiety (as measured by the STAI Y1), the VR "walk in the woods" had the greatest reduction from pre to post (6.4 points, SD = 5.98) followed by VR "forest of focus" (5.8 points, SD = 9.29), computer screen "forest of focus" (5.0 points, SD = 8.89), and computer screen "walk in the woods" (4.1 points, SD = 6.22). All 4 sessions had a significant decrease in score from pre to post (P-values ≤.005), but there was no significant difference in the change from pre- to post-session between the 4 groups (P-value = .5835).ConclusionThe use of the VR among HCP has promise for reducing stress among health care providers during a high stress period, such as a pandemic but much larger studies are needed.
| S-EPMC8972930 | biostudies-literature
Project description:Introduction:Laceration repair is a core procedural skill in which pediatric residents are expected to attain proficiency per the Accreditation Council for Graduate Medical Education. Restricted trainee work hours have decreased clinical opportunities for laceration repair, and simulation may be a modality to fill that clinical gap. There is a therefore a need for objective measures of pediatric resident competence in laceration repair. Methods:We created a global rating scale and checklist to assess laceration repair in the pediatric emergency department. We adapted the global rating scale from the Objective Structured Assessment of Technical Skills tool used to evaluate surgical residents' technical skills and adapted the checklist from a mastery training checklist related to infant lumbar puncture. We tested both tools in the pediatric emergency department. Eight supervising physicians used the tools to evaluate 30 residents' technical skills in laceration repair. We performed validation testing of both tools in the simulation environment. Based on formal evaluation, we developed a video to train future evaluators on the use of the global rating scale. Results:The global rating scale and checklist showed fair concordance across reviewers. Both tools received positive feedback from supervising physicians who used them. Discussion:We found that the global rating scale and checklist are more applicable to formative, rather than summative, training for resident laceration repair. We recommend using these educational tools with trainees in the simulation environment prior to trainees performing laceration repairs on actual patients.
| S-EPMC6415009 | biostudies-literature
Project description:AimsThe prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children.Materials and methodsThis was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups.ResultsThirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group (p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group (p value = 0.016).ConclusionThe implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol.Clinicaltrialsgov identifierNCT03018977.How to cite this articleTiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.
| S-EPMC7435087 | biostudies-literature
Project description:BackgroundVirtual reality (VR) simulators have become widespread tools for training medical students and residents in medical schools. Students using VR simulators are provided with a 3D human model to observe the details by using multiple senses and they can participate in an environment that is similar to reality.ObjectiveThe aim of this study was to promote a new approach consisting of a shared and independent study platform for medical orthopedic students, to compare traditional tendon repair training with VR simulation of tendon repair, and to evaluate future applications of VR simulation in the academic medical field.MethodsIn this study, 121 participants were randomly allocated to VR or control groups. The participants in the VR group studied the tendon repair technique via the VR simulator, while the control group followed traditional tendon repair teaching methods. The final assessment for the medical students involved performing tendon repair with the "Kessler tendon repair with 2 interrupted tendon repair knots" (KS) method and the "Bunnell tendon repair with figure 8 tendon repair" (BS) method on a synthetic model. The operative performance was evaluated using the global rating scale.ResultsOf the 121 participants, 117 participants finished the assessment and 4 participants were lost to follow-up. The overall performance (a total score of 35) of the VR group using the KS method and the BS method was significantly higher (P<.001) than that of the control group. Thus, participants who received VR simulator training had a significantly higher score on the global rating scale than those who received traditional tendon repair training (P<.001).ConclusionsOur study shows that compared with the traditional tendon repair method, the VR simulator for learning tendon suturing resulted in a significant improvement of the medical students in the time in motion, flow of operation, and knowledge of the procedure. Therefore, VR simulator development in the future would most likely be beneficial for medical education and clinical practice.Trial registrationChinese Clinical Trial Registry ChiCTR2100046648; http://www.chictr.org.cn/hvshowproject.aspx?id=90180.
| S-EPMC8314161 | biostudies-literature
Project description:ContextPatients in the Pediatric Intensive Care Unit (PICU) are limited in their ability to engage in developmentally typical activity. Long-term hospitalization, especially with minimal interpersonal engagement, is associated with risk for delirium and delayed recovery. Virtual reality (VR) has growing evidence as a safe, efficacious, and acceptable intervention for pain and distress management in the context of uncomfortable healthcare procedures, and for enhancing engagement in, and improving outcomes of rehabilitation therapy.HypothesisCritically ill children may experience high levels of engagement and physiologic effects while engaging with VR.Methods and modelsThis cross-sectional study of 3-17-year-old children admitted to a PICU used a VR headset to deliver 360-degree immersive experiences. This study had a mixed-method approach, including standardized behavioral coding, participant and parent surveys, and participant physiologic responses. Investigators noted comments the child made about VR, observed emotional responses, and documented an engagement score. To determine physiologic response to VR, integer heart rate variability (HRVi) was collected 30 min before, during, and 30 min after VR.ResultsOne hundred fifteen participants were enrolled from 6/18 to 10/19, and they interacted with VR for a median of 10 min (interquartile range 7-17). Most children enjoyed the experience; 83% of participants smiled and 36% laughed while using VR. Seventy-two percent made positive comments while using VR. The strongest age-related pattern regarding comments was that the youngest children were more likely to share the experience with others. Seventy-nine percent of participants were highly engaged with VR. Ninety-two percent of parents reported that VR calmed their child, and 78% of participants felt that VR was calming. HRVi Minimum scores were significantly higher during VR than pre- (p < 0.001) or post-VR (p < 0.001). There was no significant difference between pre-and post-VR (p = 0.387); therefore, children returned to their pre-intervention state following VR.Interpretations and conclusionsChildren admitted to the PICU are highly engaged with and consistently enjoyed using VR. Both participants and parents found VR to be calming, consistent with intra-intervention physiologic improvements in HRVi. VR is an immersive tool that can augment the hospital environment for children.
| S-EPMC8995472 | biostudies-literature