Dataset Information

Efficacy of Smartphone Active and Passive Virtual Reality Distraction vs Standard Care on Burn Pain Among Pediatric Patients: A Randomized Clinical Trial.

ABSTRACT:

Importance

It is unknown whether smartphone-based virtual reality (VR) games are effective in reducing pain among pediatric patients in real-world burn clinics.

Objective

To evaluate the efficacy of a smartphone VR game on dressing pain among pediatric patients with burns.

Design, setting, and participants

This 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.

Interventions

Active 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 measures

Patients 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).

Results

A 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 relevance

In 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 registration

ClinicalTrials.gov Identifier: NCT04544631.

SUBMITTER: Xiang H

PROVIDER: S-EPMC8218073 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundVirtual reality (VR) gaming is considered a safe and effective alternative to standard pain alleviation in the hospital. This study addressed the potential effectiveness and feasibility of a VR game that was developed by our research team for repeated at-home burn dressing changes.MethodsA randomized clinical trial was conducted among patients recruited from the outpatient burn clinic of a large American Burn Association-verified pediatric burn center between September 2019 and June 2021. We included English-speaking burn patients aged 5-17 years old requiring daily dressing changes for at least 1 week after first outpatient dressing change. One group played an interactive VR game during dressing changes, while the other utilized standard distraction techniques available in the home for up to a week. Both child and caretaker were asked to assess perceived pain on a numerical rating scale (NRS) of 0-10. For the VR group, patients were also asked to rate various aspects of the VR game on a NRS of 0-10 and caregivers were asked questions assessing ease of use.ResultsA total of 35 children were recruited for this study with 24 fully completing study measures. The majority of participants were male (n=19, 54.3%), White (n=29, 82.9%), and with second degree burns (n=32, 91.4%). Children and caregivers in the VR group reported less pain than the control group at the 4th dressing change. Participants in the VR group showed a clinically meaningful (≥30%) reduction in child-reported overall pain (33.3%) and caregiver-reported worst pain (31.6%) in comparison with subjects in the control group. Children's satisfaction with the VR remained at a high level across dressing changes over the 1-week period, with reported realism and engagement increasing over time. Over half of the children (54.5%) enjoyed playing the game and did not report any challenges nor any side effects.ConclusionsSubjects found the VR to be a useful distraction during home dressing changes and reported no challenges/side effects. VR should be considered as a nonpharmacologic companion for pain management during at-home burn dressing changes.Trial registrationClinicalTrials.gov Identifier: NCT04548635. Registered September 14, 2020-retrospectively registered.

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: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:IntroductionVirtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.Methods and analysisThis is a single centre, prospective, randomised, clinical trial. Ninety children/adolescents, aged 8-18 years, presenting for Nuss repair of pectus excavatum will be randomised to 1 of 3 study arms (VR-GR, VR-D and 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10 min. Patients randomised to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomised to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomised to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcome is pain intensity. Secondary outcomes include pain unpleasantness, anxiety and opioid and benzodiazepine consumption.Ethics and disseminationThis study follows Standard Protocol Items: Recommendations for Interventional Trials guidelines. The protocol was approved by the Cincinnati Children's Hospital Medical Center's institutional review board. Patient recruitment began in July 2020. Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04351776.