Dunn Amy, Patterson Jeremy, Biega Charmaine F, Grishchenko Alice, Luna John, Stanek Joseph R, Strouse Robert
Nationwide Children's Hospital, Division of Hematology, Oncology and BMT, The Ohio State University, Columbus, OH, United States.
The Research Institute at Nationwide Children's Hospital, Columbus, OH, United States.
JMIR Serious Games. 2019 Jan 9;7(1):e10902. doi: 10.2196/10902.
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.
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.
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.
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.
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.
Clinical Trials.gov NCT03507582; https://clinicaltrials.gov/ct2/show/NCT03507582 (Archived by WebCite at http://www.webcitation.org/73G75upA3).
在常规医疗程序中经常需要使用针头。患有严重血友病的儿童需要强化静脉注射（IV）治疗来治疗和预防危及生命的出血，并且要接受数百次静脉注射程序。对与针头相关程序的恐惧可能会导致未来避免接受医疗保健并产生不良临床结果。虚拟现实（VR）是程序进行期间一种很有前景的分散注意力技术，但用于儿科医疗保健目的的商用VR平台存在的障碍阻碍了其广泛应用。
我们假设可以创建一个用于儿科血友病护理的VR平台，允许临床医生进行编排，并且在作为复杂医疗保健一部分的静脉注射程序中用于分散注意力时是安全可行的。
我们创建了一个VR平台，包括无线、可调节、一次性头戴设备和一套远程编排的VR游戏。该平台是针对儿科血友病患者群体定制的，需要免提导航以便在进行程序时能够接触到儿童的手或手臂。一名血友病护士观察程序并进行编排。试验的主要终点是安全性。2016年6月至12月在一项单中心随机临床试验中评估了该平台的初步可行性和可用性。参与者为6至18岁的血友病儿童。在获得知情同意后，招募了25名患者并进行随机分组。每位受试者、1名护理人员和1名血友病护士编排人员使用锚定的、组合的改良视觉模拟（VAS）/面部表情量表评估术前紧张或焦虑程度。然后，每位参与者接受一次定时静脉注射程序，采用VR或标准护理（SOC）分散注意力方法。每个评估者在静脉注射程序完成时使用VAS/面部表情量表评估分散注意力方法，问题针对可用性、参与度、对程序焦虑的影响、对程序疼痛的影响以及分散注意力技术的受欢迎程度。参与者、护理人员和护士还对他们未来希望在程序中使用VR的程度进行了评分。为比较两组之间的程序时间长度，使用了曼-惠特尼检验。
在25名入组儿童中，24名纳入了主要分析。未出现安全问题或VR不适。VR组的中位程序时间为10（范围1 - 31）分钟，与SOC组的9（范围3 - 20）分钟相当（P = 0.76）。两组患者均报告分散注意力对程序焦虑和疼痛有积极影响。总体而言，在80%（34/45）的VR评估中，儿童、护理人员和护士表示他们希望在未来的程序中使用VR。
我们证明了可以开发一个编排好的VR环境，并在儿科血友病护理期间安全地用于静脉注射干预时分散注意力。该平台有可能改善医疗程序期间的患者体验。
ClinicalTrials.gov NCT03507582；https://clinicaltrials.gov/ct2/show/NCT03507582（由WebCite存档于http://www.webcitation.org/73G75upA3）
