Dataset Information

A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Needles are frequently required for routine medical procedures. Children with severe hemophilia require intensive intravenous (IV) therapy to treat and prevent life-threatening bleeding and undergo hundreds of IV procedures. Fear of needle-related procedures may lead to avoidance of future health care and poor clinical outcomes. Virtual reality (VR) is a promising distraction technique during procedures, but barriers to commercially available VR platforms for pediatric health care purposes have prevented widespread use. OBJECTIVE:We hypothesized that we could create a VR platform that would be used for pediatric hemophilia care, allow clinician orchestration, and be safe and feasible to use for distraction during IV procedures performed as part of complex health care. METHODS:We created a VR platform comprising wireless, adjustable, disposable headsets and a suite of remotely orchestrated VR games. The platform was customized for a pediatric hemophilia population that required hands-free navigation to allow access to a child's hands or arms for procedures. A hemophilia nurse observing the procedure performed orchestration. The primary endpoint of the trial was safety. Preliminary feasibility and usability of the platform were assessed in a single-center, randomized clinical trial from June to December 2016. Participants were children with hemophilia aged 6-18 years. After obtaining informed consent, 25 patients were enrolled and randomized. Each subject, 1 caregiver, and 1 hemophilia nurse orchestrator assessed the degree of preprocedural nervousness or anxiety with an anchored, combined modified visual analog (VAS)/FACES scale. Each participant then underwent a timed IV procedure with either VR or standard of care (SOC) distraction. Each rater assessed the distraction methods using the VAS/FACES scale at the completion of the IV procedure, with questions targeting usability, engagement, impact on procedural anxiety, impact on procedural pain, and likability of the distraction technique. Participants, caregivers, and nurses also rated how much they would like to use VR for future procedures. To compare the length of procedure time between the groups, Mann-Whitney test was used. RESULTS:Of the 25 enrolled children, 24 were included in the primary analysis. No safety concerns or VR sickness occurred. The median procedure time was 10 (range 1-31) minutes in the VR group and was comparable to 9 (range 3-20) minutes in the SOC group (P=.76). Patients in both the groups reported a positive influence of distraction on procedural anxiety and pain. Overall, in 80% (34/45) of the VR evaluations, children, caregivers, and nurses reported that they would like to use VR for future procedures. CONCLUSIONS:We demonstrated that an orchestrated, VR environment could be developed and safely used during pediatric hemophilia care for distraction during IV interventions. This platform has the potential to improve patient experience during medical procedures. TRIAL REGISTRATION:Clinical Trials.gov NCT03507582; https://clinicaltrials.gov/ct2/show/NCT03507582 (Archived by WebCite at http://www.webcitation.org/73G75upA3).

SUBMITTER: Dunn A

PROVIDER: S-EPMC6329423 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial.

Dunn Amy A Patterson Jeremy J Biega Charmaine F CF Grishchenko Alice A Luna John J Stanek Joseph R JR Strouse Robert R

JMIR serious games 20190109 1

<h4>Background</h4>Needles are frequently required for routine medical procedures. Children with severe hemophilia require intensive intravenous (IV) therapy to treat and prevent life-threatening bleeding and undergo hundreds of IV procedures. Fear of needle-related procedures may lead to avoidance of future health care and poor clinical outcomes. Virtual reality (VR) is a promising distraction technique during procedures, but barriers to commercially available VR platforms for pediatric health ...[more]

PMID: 30626567

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Project description:BackgroundPerioperative pediatric anxiety is common and can have a negative psychological impact on children undergoing surgery and anesthesia. Studies have shown an incidence of anxiety at induction of up to 50%. Audiovisual distraction, including virtual reality (VR), is a noninvasive, nonpharmacological modality that may reduce perioperative anxiety. The goal of this study was to determine whether immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA) in pediatric patients reduced preoperative anxiety.MethodsIn this randomized-controlled, parallel-group study, 71 children 5-12 years of age scheduled for elective surgery with GA were randomly allocated to a VR group or a non-VR (No VR) control group. VR group patients underwent audiovisual distraction with a VR headset during induction in the operating room, whereas the control group received no audiovisual distraction. The primary outcome was the Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety: in the preoperative holding area before randomization, on entering the operating room, and during induction of GA. The primary outcome was analyzed using univariate analysis and a linear mixed-effects model. Secondary outcomes included postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction.ResultsAverage patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female. Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients). No patients received preoperative anxiolytic medication. Baseline mYPAS scores were not different between the groups, with scores of 28.3 (23.3-28.3) (median [interquartile range {IQR}]) in both. The change in mYPAS scores from baseline to time of induction was significantly lower in the VR group versus control group (0.0 [0.0-5.0] vs 13.3 [5.0-26.7]; P < .0001). In the mixed-effects model, the VR group had an estimated 6.0-point lower mYPAS score (95% confidence interval [CI], 0.7-11.3; P = .03) at room entry than the No VR group, and 14.5-point lower score (95% CI, 9.3-19.8; P < .0001) at induction versus control. Randomization to VR did not alter parental anxiety (0 [-2 to 2]), pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 [-8 to 2]) (difference in medians [95% CI]).ConclusionsThis study demonstrates a reduction in pediatric preoperative anxiety with the use of VR. Preoperative VR may be an effective noninvasive modality for anxiolysis during induction of anesthesia in children.

Project description:IntroductionIntravenous (IV) insertions are among the most performed procedures for children seeking medical care; they are often a painful and stressful experience for both children and their caregivers. Paediatric distress and pain that is inadequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for both the family and clinical team. We hypothesise that distraction via an immersive virtual reality (VR) experience may reduce the associated distress for children undergoing IV insertions.Methods and analysisThis two-armed randomised controlled superiority trial will be conducted in a Canadian paediatric emergency department and will aim to enrol 80 children overall. Children will be randomised to receive either departmental standard of care alone or standard of care plus an immersive VR experience. Children 6-17 years of age who are undergoing IV insertion and have topical anaesthetic application will be considered for inclusion. Our primary objective is to compare the reduction of distress between the two study arms. The primary outcome will be the child's observed distress score as measured by the Observational Signs of Behavioral Distress-Revised tool. Secondary outcomes include the child's pain intensity and fear, parental anxiety, satisfaction with the IV procedure, as well as adverse events. Recruitment launched in September 2020 and is expected to end in March 2022.Ethics and disseminationThis study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent will be obtained from parents or guardians, and assent from children. Study data will be submitted for publication irrespective of results. This study is funded through a Women and Children's Health Research Institute Innovation grant. Purchase of the VR equipment was facilitated through a Stollery Children's Hospital Foundation small equipment grant.Trial registration numberNCT04291404Cite Now.

Project description:BackgroundDifferent distraction techniques have been used in dentistry and have shown great results in managing anxious pediatric patients specially during local anesthesia administration. One of the recently invented techniques is virtual reality. The purpose of the study was to evaluate the effect of virtual reality distraction on anxiety and pain during buccal infiltration anesthesia in pediatric patients.MethodsHealthy, cooperative 6- to 12-year-old children requiring buccal infiltration anesthesia were randomly assigned to a test or control group. In the test group, local anesthesia was administered while the subjects were watching a cartoon video using virtual reality goggles. Subjects in the control group watched a cartoon video on a screen during the administration of local anesthesia. To assess anxiety in both groups, heart rate was recorded using a pulse oximeter at five time points: (1) once the subject sets on the dental chair as a baseline; (2) when video is on; (3) at topical anesthesia application; (4) during needle insertion; (5) after the administration of local anesthesia. The face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale and the Wong-Baker FACES pain rating scale were used to assess pain.ResultsA total of 50 subjects were included with a mean age of 8.4 ± 1.46 years. Twenty-nine (58.0%) of the subjects were females. The mean heart rate at all time points except baseline was significantly higher among the test group compared to the control group. Multiple regression analysis showed that younger subjects and females had higher mean FLACC behavioral pain assessment scale scores (P = 0.034 and P = 0.004, respectively) regardless of the distraction technique used. Younger subjects and subjects with higher baseline heart rate reported higher mean Wong-Baker FACES pain rating scale score (P = 0.031 and P = 0.010, respectively), controlling for all other variables.ConclusionFemale subjects and the younger age group were more likely to report higher pain scores during local anesthesia administration regardless of the type of distraction used.Trial registrationThe study was retrospectively registered in ClinicalTrials.gov with the identifier: NCT04483336 on 23/07/2020.

Project description:BackgroundVirtual reality (VR) is used as a distraction measure during painful clinical procedures associated with the use of needles. These procedures include vaccinations, blood draws, or the administration of medications, which can cause children to feel increased levels of pain and fear.ObjectiveThe objective of this study was to collect and analyze the current evidence regarding the effectiveness of VR as a tool to distract children from pain and fear during needle procedures as compared to that of standard techniques.MethodsA systematic review and meta-analysis was performed. We included randomized clinical trials (RCTs) or quasi-RCTs with participants younger than 21 years who underwent needle procedures in which the main distraction measure used was VR and where the main outcome measure was pain. The databases searched included the PubMed, Web of Science, Scopus, PsycINFO, CINAHL, and Cochrane libraries. In this systematic review, the studies were analyzed by applying the Critical Appraisal Skills Program guide in Spanish and the Jadad scale. In the meta-analysis, the effect size of the studies was analyzed based on the results for pain and fear in children.ResultsFrom 665 unique search results, 21 studies were included in this systematic review, most of which reported low methodological quality. The study sample cohorts ranged from a minimum of 15 participants to a maximum of 220 participants. Ten studies were included in the meta-analysis. The global effect of using VR as a distraction measure was a significant reduction in pain (inverse variance [IV] -2.37, 95% CI -3.20 to -1.54; Z=5.58; P<.001) and fear (IV -1.26, 95% CI -1.89 to -0.63; Z=3.92; P<.001) in children in the experimental groups.ConclusionsThe quality of the studies was mostly low. The main limitations were the impossibility of blinding the participants and health care personnel to the VR intervention. Nonetheless, the use of VR as a distraction measure was effective in reducing pain and fear in children during procedures involving needles.

Dataset Information

A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial.

Publications

A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial.

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