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

A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric... 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. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al 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) (JMIR Serious Games 2019;7(1):e10902) doi: 10.2196/10902 KEYWORDS anxiety; distraction; hemophilia; intravenous; mobile phone; needle; pediatric; virtual reality low-cost HMDs, at around US $800 for the smart device and Introduction approximately US $35 for HMD. In either case, these estimates do not include the cost of content or technical support to Medical procedures involving needles induce fear in most configure and maintain the systems. Additionally, the unit is people, especially children [1-6]. However, treatment for some tethered to the personal computer and, as a result, cannot easily medical conditions requires frequent needle sticks. Balancing move between locations. Infection concerns exist with the treatment needs for life-threatening conditions with the fear nondisposable headsets particularly in a pediatric setting, such and anxiety imposed by the mechanism of these treatments is as a hematology or oncology clinic. Additionally, most an important challenge for the medical community. In addition commercial VR platforms do not allow a medical provider to to the load needle sticks impose on patients and families, the direct or modify the VR environment in response to patient medical system and medical providers also bear burden and distress and also focus on the experience of patients and not of expenses related to needles. One of the conditions that requires caregivers. the most needle-intensive care is hemophilia. Both hemophilia A (HA) and B (HB) are severe congenital bleeding disorders. Despite the barriers to VR implementation described above, we Without intravenous (IV) infusions of clotting factor hypothesized that a children’s hospital-based team with expertise concentrates, children with hemophilia experience life- and in hemophilia patient care and user experience technology could limb-threatening bleeding. Most children with hemophilia begin create a safe and clinically feasible VR ecosystem that met the routine IV infusions of factor concentrate between the age of 1 needs of patients, caregivers, and medical providers during IV and 3 years and continue infusions 2-3 times per week for life. procedures. Assessing safety and testing the feasibility of the This translates to thousands of necessary needle sticks over the designed ecosystem in a complex clinical environment were course of their lives and a high treatment burden related to the goals of the project. A comprehensive hemophilia clinic needles [7]. Needle fear related to IV procedures, particularly visit was selected to test the safety, feasibility, and likeability in children with hemophilia, can progress to of the ecosystem. During these visits, patients see multiple blood-injection-injury phobia (needle phobia), treatment providers in addition to having IV procedures, so the efficiency avoidance, and poor adherence, all of which can contribute to of clinic flow is vitally important. We specifically designed the poor medical outcomes [8]. Psychological interventions, such ecosystem for children with hemophilia because patients with as distraction and hypnosis, can reduce needle-related pain and hemophilia need a frequent distraction from needles safe and distress in pediatrics [9]. A recent systematic review and successful integration into a complex clinic environment would meta-analysis demonstrated that distraction could lead to demonstrate the likelihood of feasibility in less complex reductions in child- and observer-reported pain and distress situations. during needle procedures. However, among the major elements of distraction, the relative importance of (1) no or low-tech Methods versus high-tech distracters; (2) child engaging versus passive distracters; (3) degree of adult involvement; and (4) the Virtual Reality Platform Design availability of child choice in the success of these distracters is The VR platform design team consisted of the Nationwide unclear [10]. Specific virtual reality (VR)-based distractions Children’s Hospital Hemophilia Treatment Center (HTC) staff have shown promise in clinical settings, such as dentistry, IV and the user experience technology team. The HTC staff placement, occupational or physical therapy, and burn care included a hematologist, nurse clinicians, a social worker, and [9,11-24]. In particular, VR approaches have demonstrated a psychologist. The user experience team included a project decreased pain associated with dental procedures, physical lead, industrial designer, and 2 game designers, 1 of which also therapy, and burn dressing changes. Although various served as the illustrator and visual designer. The team designed consumer-grade VR technologies are available, most carry the platform for boys and girls aged 6-18 years with HA or HB. barriers that prevent clinical implementation [11-18,20-24]. Ideal features were identified through reoccurring meetings, Cost is another barrier, with the top-selling commercial unit which included observation of HTC visits and IV procedures. having an approximate cost of US $500. This includes the Specific platform design needs were identified. First, the cost head-mounted display (HMD), wireless controllers, and of the overall system needed to be low. The system needed to proximity sensors, but not a personal computer capable of be technically easy to implement and maintain for the nursing running VR content, with a cost of approximately US $2000. team. Games needed to be pediatric friendly but of sufficient On the low end, VR content is available for smartphones and https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al quality to maintain the interest of patients and families. Study Design, Patients, and Randomization Additionally, the video content needed to limit the possibility A prospective, monocentric, unblinded, randomized clinical of VR sickness. Importantly, the majority of IV infusions require trial was performed (Clinical Trials.gov NCT03507582). that the medical team has easy access to the hands and arms of Multimedia Appendix 1 provides details of the trial protocol. a patient. This meant that game control mechanics needed to After Institutional Review Board approval, children with HA be hands free and help ensure the patient remained still. Because or HB, aged 6-18 years, who were cared for in our HTC were medical care is fluid and each patient experience is unique, the screened for eligibility. Eligible patients had to be seen for a design team needed to allow the medical team to orchestrate comprehensive HTC visit defined as seeing >3 specialty the patient experience in the real-time to meet individual needs. hemophilia providers during one visit and have a clinically We also sought ways to include caregivers in the game indicated IV laboratory draw or factor infusion. Patients seen experience because parental anxiety around IV procedures can between July 1 and December 31, 2016, were eligible for contribute to poor outcomes, and family-centered care is an participation if they and their parents or guardians could speak important tenet of pediatric care. The team was also mindful of and write in English. Patients who were unable to use the VR the need of the system to minimize the risk of transmitting equipment (visual, cognitive, or hearing impairment that infections agents from any game component. Each element of precluded engagement with the VR environment), who had a the ecosystem—the HMD, games, and the orchestration—was known history of severe motion sickness, or uncontrolled refined with input from volunteer pediatric hemophilia nurse seizures were not eligible (n=1). Those who met screening clinicians, pediatric hematologists, and children without criteria were approached for participation (n=25). A hemophilia hemophilia. The ecosystem components were also demonstrated nurse obtained paper informed consent and age-appropriate at hemophilia community events, and patients with hemophilia assent. Enrolled patients were block randomized by and their families gave feedback to the design team. The final computer-generated random allocation to study groups using a VR intervention used for the clinical trial consisted of custom, prespecified seed. The nurse performing randomization was cordless, multisized, disposable headsets, which enabled the blinded to group allocation. Recruited participants were use of VR through iPod Touch, and immersive custom games randomly assigned using a 2:1 ratio to VR or standard of care with hands-free navigation. Navigation techniques included (SOC) distraction with a stratified block design to maintain age head glances and breath. The mechanism for nurse orchestration strata of 12 patients aged 6-12 years and 12 patients aged 13-18 (Figure 1; Multimedia Appendix 1) was software running on years. SOC distraction was any technique routinely available an iPad dashboard that wirelessly communicated to iPod Touch. in the hematology clinic that did not include VR (ie, smart The orchestration dashboard offered a suite of tools allowing a devices, bubbles, and videos). nurse to respond to patient needs by deploying mini-games or Study Intervention providing relocation to a new setting in the VR ecosystem. The dashboard also allowed parents to monitor their child’s progress. All enrolled patients had a clinically indicated IV procedure. A Moreover, an expert practitioner could observe patient state procedure timer and survey instruments were incorporated into and, upon noticing stress, could trigger an intervention to act the orchestration iPad. A modified visual analog (VAS)/FACES as a distraction method. The system’s communication platform (Figure 2) rating scale was used to assess the distraction utilized an internal server as a relay between the dashboard and techniques. The scale did not undergo specific psychometric the iOS device, which ran VR activities. All signal messages testing; however, the FACES scale is routinely used in our passed through the intermediary system and were logged and hemophilia clinic. A unipolar, horizontal scale was employed tracked against the identifier for the orchestrated session and to increase understandability, uniformity, and sensitivity [25-27]. the type of orchestration command. Message types recorded All participants, caregivers, and nurses (raters) were educated included commands to enter or exit a mini-game, transport the in how to use the VAS/FACES scale prior to beginning the patient to a virtual location, connect to a paired iOS device, study procedure by sliding a bar below the scale picture in adjust the volume, open the video feed from the iOS device’s response to an anchored question. Raters were not blinded to camera, and calibration of the headset units for fit and viewing participant’s distraction group, and each rater answered the preference. After finalization of the platform, safety and study questions independently. Immediately before the IV feasibility of platform integration into a routine comprehensive procedure, children in the VR group were introduced to the HTC visit were explored. Comprehensive visits included care headset, game options, and navigation techniques. Then, before from multiple providers during a specified timeframe, and being positioned for the procedure, each patient, a caregiver anything that impeded clinic flow was judged not feasible. The with them for the procedure, and a hemophilia nurse assessed complexity of the care for patients with hemophilia is reflected the participant’s level of preprocedural anxiety using a in the number and diversity of providers available in each HTC (VAS)/FACES scale answering the question: How worried or clinic. Patients are seen for comprehensive care visits once or nervous is or are you or your child or your patient about the IV twice per year and during those visits are seen by numerous procedure? Sliding the bar to the left (toward 0) represented a providers based on individual needs. This can include low degree of preprocedural worry or nervousness and to the hematologists, nurse clinicians, research nurses, psychologists, right (toward 100) represented the highest degree of nervousness social workers, physical therapists, nutritionists, orthopedists, or worry. The terms nervous and worry were substituted for dentists, genetic counselors, radiologists, advocacy coordinators, anxiety owing to the young age of many participants. After and phlebotomy staff. For the pilot study, the length of the IV being positioned for the procedure, patients in the SOC group procedure time was chosen as a surrogate marker of feasibility. used whatever distraction they preferred, whereas patients in https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al the VR group put on the headset, launched the game of their comprehensive HTC visit. Safety concerns included discomfort choice, and explored the VR environments. The nurse clinician from HMD, infection, and VR sickness. Barriers to feasibility was located next to the patient and deployed VR orchestration that were assessed included technical issues with the set-up or tools as she deemed necessary. The guardian was present orchestration. The primary surrogate marker of feasibility was throughout in both the groups. The study methodology was not the duration of the IV procedure in both study groups. Procedure altered during the trial. No revisions to the VR platform were time was the length of time from the moment a patient was performed or required during the trial. positioned for the procedure to the completion of the procedure, and the primary and secondary outcomes did not change during Primary Outcome the course of the trial. No VR platform performance issues or The primary aim of the study was to assess safety concerns and unexpected events related to the platform were encountered feasibility of integration of the VR platform into a during the trial. Figure 1. Manual orchestration of child engaging events in a virtual reality environment from a connected virtual digital interface from an embedded viewpoint. Figure 2. An example of the modified visual analog/FACES scale. VR: virtual reality. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al internal quality checks. Demographic data were captured from Secondary Outcomes the patients’ electronic medical records. All demographic and Effectiveness of the Distraction Technique safety data were described using summary statistics. To evaluate Both patient groups assessed the effectiveness of their distraction the hypothesis that the procedure time would be similar between techniques following the procedure by answering 3 questions the intervention and SOC groups, Mann-Whitney test was used. as follows. (1) “Did the distraction technique keep you/your The length of IV procedure time was summarized by presenting child /your patient engaged?” The anchors were 0=It really kept mean and corresponding 95% CI as well as median and range. them engaged and 100=It really did not keep them engaged; (2) Kruskal-Wallis tests were applied to compare VAS/FACES “Do you think the distraction technique/s changed you/your scores given by the 3 rater groups as the secondary aim. Scores child/your patient’s nervousness/anxiety level during the IV for the rater groups were summarized with medians and ranges. procedure?” The anchors were 0=it decreased Statistical analyses were performed using the base R statistical nervousness/anxiety a lot and 100=it increased package (R Foundation for Statistical Computing, Vienna, nervousness/anxiety a lot; (3) “How did the distraction Austria). technique/s affect pain during your/your child/your patient’s IV procedure?” The anchors were 0=it made pain a lot better Results and 100=it made pain a lot worse. Demographics Usability and Likeability In this study, 26 patients were screened for enrollment. There For patients randomized to the VR arm, data on the use of the was 1 screen failure in a patient with moderately controlled VR equipment were recorded by the nurse orchestrator at the seizures; therefore, 25 eligible patients aged 6-18 (median age, end of each procedure. Data were categorized if a participant 13) years participated in study (Figure 3). In total, 16 patients wore the VR equipment: (1) during the entire procedure; (2) were randomized to VR and 9 to SOC group; 1 patient in the part of the procedure; or (3) only prior to the procedure. In VR arm was excluded from the analysis because of inability to addition, participants were asked to rate the usability of the VR wear the HMD over glasses. Of the remaining 24 patients, 83% equipment using the VAS/FACES scale to answer “How easy (20/24) participants were males and 17% (4/24) were females; was it for you/your child/your patient to use the VR equipment?” 54% (13/24) had HA and 46% (11/24) had HB, 42% (10/24) A score of 0 represented “really easy to use,” and a score of 100 had severe hemophilia, 58% (14/24) had nonsevere hemophilia, correlated with “really hard to use.” Lastly, participants were and 54% (13/24) were on routine prophylaxis (Table 1). No asked to use the VAS/FACES scale to assess the VR likeability patient harms or unintended effects were seen in either the SOC by answering “How much would you/your child/your patient or VR group. like to use VR for future IV procedures?” A score of 0 equated to “they would really like to use VR again” and 100 meant “they Outcomes would really not like to use it again.” Safety Statistical Analysis No adverse events occurred during the trial. No patient experienced VR sickness, seizures, discomfort from the HMD, This was a pilot feasibility study in a rare population. With or infection-related events related to the VR experience. insufficient background data on the overall feasibility of using VR technology in a clinical setting, a sample of 24 patients was Procedure Time selected to collect pilot data on the safety and usability, logistical The median procedure time was 10 (range 1-31) minutes in the issues of implementation, and to assess the durability and VR group, and was similar to 9 (range 3-20) minutes in the SOC adaptability in the design of the equipment. The study was group (P=.76; Table 1). The mean procedure time was 12.3 designed to be randomized and include a control SOC group to minutes (95% CI 7.2-17.4) in the VR group and 10.1 minutes perform a preliminary test on the hypothesis that the length of (95% CI 5.7-14.6) in the SOC group. time for IV procedures would be similar between the groups, but the sample size did not allow testing for equivalence. The Virtual Reality Equipment Usability justifications for this sample size were based on the rationale In this study, 60% (9/24) patients wore VR equipment during about feasibility, obtaining adequate precision on numerical their entire procedure, 27% (4/24) utilized VR for part of their estimates, and regulatory considerations [19]. This sample size procedure, and 13% (2/24) only used VR prior to the procedure. allowed for evaluating the potential utility of the VR distraction Of the 4 participants who used VR for a part of their procedure, technique on a wide range of ages and would result in parameter 1 removed the headset after the IV stick, while 3 used VR at estimates that would aid in adequately powering future studies the beginning of their procedures, removed the headset to watch that would directly assess the benefits of VR in clinical settings. the IV stick, and then resumed VR. The 2 participants, who Clinical data, including survey instrument data and adverse only used VR prior to their procedures, chose to watch the events, were entered into a hospital-compliant internet data entirety of the IV procedure. No technical issues were noted entry system (REDcap) that included password protection and with the orchestration dashboard, headsets, or game hardware. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al Figure 3. Trial flow diagram. VR: virtual reality. Table 1. Participants’ characteristics and median procedure times. Variable Virtual reality (n=15) Control (n=9) P value Males, n (%) 12 (80) 8 (89) .99 Median age, years 12.2 12.8 .56 Hemophilia type, n (%) .99 Hemophilia A 8 (53) 5 (56) Hemophilia B 7 (47) 4 (44) Hemophilia severity, n (%) .36 Mild 3 (20) 3 (33) Moderate 4 (27) 4 (44) Severe 8 (53) 2 (22) Routine prophylaxis, n (%) 9 (60) 4 (44) .68 Median procedure time, minutes 10 9 .76 Median orchestration events, n 17 N/A N/A N/A: not applicable. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al Table 2. Median pre- and postprocedural visual analog/FACES scale score. Question Virtual reality Nervousness prior to intravenous procedure (0=None, 100=Very) Nurse response 14 Caregiver response 25 Patient response 3 Assessment of the distraction technique Engaged or attentive (0=Yes it did, 100=Did not) Nurse response 13 Caregiver response 13 Patient response 18 Impact on anxiety (0=decreased, 100=increased) Nurse response 3 Caregiver response 15 Patient response 8 Impact on pain (0=lessened, 100=worsened) Nurse response 4 Caregiver response 4 Patient response 3 Likability (0=really like, 100=did not like) Nurse response 1 Caregiver response 4 Patient response 3 Questions for the virtual reality group only Ease of using the virtual reality equipment (0=Easy, 100=Hard) Nurse response 2 Caregiver response 9 Patient response 7 Virtual reality for future intravenous procedures (0=likely, 100=not likely) Nurse response 3 Caregiver response 8 Patient response 12 The VR equipment usability was favorably scored (0=easy to preference, was available for 13 of the 15 patients. A server use, 100=hard to use) with median scores of 7, 9, and 2 by storage issue led to data loss, resulting in missing orchestration participants, guardians, and the nurse, respectively (Table 2). data for 2 patients. In the remaining 13 patients, there were a Additionally, patients, caregivers, and nurses positively rated median of 17 orchestration events (range 7-28) per procedure. the desire to use VR for future procedures on a scale of 0 (would Nervousness or Worry and Pain really like to use VR again) to 100 (would really not like to use The groups did not differ statistically in preprocedural VR again); in majority (36/45, 80%) of evaluations, children, nervousness or worry, as rated by the participant (P=.67), caregivers, and nurses reported that they would like to use VR caregiver (P=.37), or nurse (P=.27; Table 2). Median for future procedures (score <50). nervousness rating for the VR group was 3 (range 0-94) and 12 Orchestration Events for the SOC group (range 0-100). Preprocedural patient The number of deliberate orchestration events per patient, nervousness did differ between age groups (P=.002) with those including commands to enter or exit a mini-game, transport the aged 6-12 years (median 50, range 0-100) being significantly player patient to a virtual location, connect to a paired iOS more nervous compared with those aged 13-18 years (median device, adjust the volume, open the video feed from the iOS 0, range 0-13). Preprocedural patient nervousness did not device’s camera, or calibrate the headset units for fit and viewing statistically differ between those on and not on prophylaxis https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al (P=.64). Median nervousness rating was 6 (range 0-94) for those world elements as the static frame of reference. This execution on prophylaxis and 27 for those not on prophylaxis (range of the technique, therefore, did not sacrifice the immersive 0-100). Both groups favorably viewed distraction techniques quality of the environment. In addition, the static frames in terms of the effect on procedural anxiety, with median introduced a form of kinesthetic reinforcement for the players’ responses being 8 for the VR group and 10 for the SOC group physical sensation to the virtual world, thus lending to their (0=the distraction technique decreased anxiety and 100=the immersive quality. For example, in the snorkeling game in the technique increased anxiety). Both VR and SOC distraction game world, players observed a projection of a virtual diving techniques had a positive influence on procedural pain (0=made mask in their game view. The projection not only acted as a pain better, 100=made pain worse); no statistically significant static frame of reference that thematically fits within the game differences were observed between raters in the VR or SOC environment but also created a relationship between the physical groups (Table 2). sensation of the physical HMD and the virtual mask as seen in the game world. Level of Engagement Our environments incorporated a core component of distraction Scores of participants, nurses, and caregivers did not theory most significantly, with affordance of control and choice significantly differ between VR and SOC distraction techniques as a means to distract [28]. This method is inherent in child in terms of the ability to engage and hold attention (0=held engaging games, with our platform bringing this method to the attention and was engaging and 100=did not hold attention and patient population through hands-free game controls and thus was not engaging; Table 2). representing the first set of pediatric-focused games, which utilize this technique while not requiring hand movement to Discussion interact and thus bringing this technique via games to patients receiving IV procedures. In total, the techniques employed Principal Findings throughout our ecosystem resulted in games that apply This study represented the first known effort to translate VR distraction theory through child engaging VR environments from a research environment to a functioning pediatric clinic while not triggering simulator sickness in participants, as environment as a comprehensive platform including custom demonstrated in the collected data. content (games), tools, and hardware (HMDs). The final platform included a high-tech, VR-based, child engaging Pain and anxiety related to procedures is a concern for patients, distraction with child choice incorporated into a platform that families, and providers, particularly in pediatric settings. allowed for need-based adult involvement. The final HMDs Because children with hemophilia have frequent needle were multisized, lightweight, and disposable and had an procedures, they represent a population that could really benefit estimated unit cost of less than US $55. If manufactured at scale, from VR-based distraction. While there is strong evidence for the estimated cost of the headphones, headsets, lenses, the success of distraction during pediatric procedures, it remains cardboard, elastic, and hooks and loops is less than US $20. unclear which of the 4 main elements of effectiveness (high vs HMDs accommodated 2 distinct size faces—one for average no or low tech, child engaging vs passive, degree of adult face size of patients over 15 years of age and another for that involvement, and availability of child choice) contribute to the of patients under 15 years of age. The game navigation was success of the technique [9,10]. Encouragingly, 87% of hands-free and wireless. Games produced were designed to participants wore the VR equipment during some or all of their appeal to a wide age range of male and female patients. Games procedure, and overall scores regarding the impact of VR on were also engineered to achieve a consistent 30 frames per pain, anxiety, usability, likeability, and level of engagement second playback rate on limited resource devices. Additionally, were favorable. games afforded the player control over a child engaging Limitations gameplay environment without requiring the use of the patients’ The trial was limited by small sample size and single-institution hands—a unique affordance ingrained in this platform. The design. Additionally, we studied only a single intervention, so system achieved hands-free gameplay via the introduction of we were unable to test if the VR platform would continue to proprietary hardware in the custom HMD, which is capable of perform well with future use in the same patient. The study was monitoring the breathing of the play and providing this feedback underpowered to evaluate the equivalence of procedure time. to the games. The system did not require a high-end computer The study was also underpowered to compare VR versus SOC or technical expertise for installation, and the orchestration attributes, but the majority of caregivers and providers had features allowed for customization to patient needs and family favorable ratings of VR, and 80% of participants, all of whom engagement. Successful incorporation into the clinic was had previous experience with SOC distraction in our clinic, demonstrated by the lack of safety and technical issues. reported a desire to use VR for future procedures. The outcomes Although our sample size did not allow equivalence comparison, related to pain and anxiety were self-reported. Addition of we had similar lengths of procedure times in both groups. objectives measures of distress, such as blood pressure and heart The games themselves mitigated the risk of the player rate, would strengthen future studies. developing simulator sickness with the standard technique of Conclusions introducing a static frame of reference during periods of motion. While static frames of reference are a conventional technique We demonstrated that a custom-designed VR platform could used to prevent VR sickness, the technique’s manifestation in be used safely during IV procedures in a pediatric hemophilia our system was novel in approach in that the technique utilized https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al population with specific design needs. These results warrant the degree to which adult involvement impacts successfulness; future exploration to assess the impact of our platform on its (3) the importance of the availability of child choice in ability to reduce the burden of IV procedures on patients, distracters; (4) ability to decrease procedural chemical sedation; parents, and clinical care providers. Future studies will be and (5) cost. Additionally, nonrandomized trials allowing needed to validate our findings in other disease populations, children to choose their distraction technique of choice during clinical settings, and institutions with larger participant numbers. procedures would generate useful information. The inclusion While patients with hemophilia may have more IV experiences of objective measures of pain and anxiety would strengthen than most children, it is likely that the positive effects of future studies. This study suggests that a custom VR ecosystem high-quality distraction would be generalizable to IV procedures with clinician orchestration is a promising modality to provide in any pediatric population. We plan larger studies comparing distraction during IV procedures in pediatrics with the potential (1) our child engaging platform versus a passive distracter; (2) to mitigate the perception of procedural pain and anxiety. Acknowledgments The authors would like to thank the patients and staff of the Nationwide Children’s Hospital HTC in Columbus, Ohio, for their support and participation. Additionally, we thank Ms Beth Burkhart, MBA, for assistance with the development and maintenance of the REDcap database, Ms Jessie Haines for administrative support, Mr Roy Goudy for video assistance, and Dr Michael Dunn for critical review of the manuscript. This study was funded by Ohio State University Center for Clinical and Translational Science/Nationwide Children’s Hospital Research Information Solutions & Innovations Voucher #3796: UL1TR001070 and The National Hemophilia Foundation Nursing Excellence Award. Conflicts of Interest AD reports grants, personal fees, and nonfinancial support from Bayer, CSL Behring, Pfizer, Shire, and Hema Biologics; grants and personal fees from Bioverativ; personal fees and nonfinancial support from Medscape and NovoNordisk; and grants from Alnylam and Octapharma during the conduct of the study, and other from Little Seed Inc outside the submitted work. JP reports grants from The Ohio State University, outside the submitted work. JL reports grants from The Ohio State University, during the conduct of the study. CFB reports personal fees from Shire. JRS, AG, and RS have no conflict of interest to declare. Authors' Contributions AD conceptualized and designed the study, designed the data collection instruments, supervised data collection, drafted the initial manuscript, and reviewed and revised the manuscript. JP conceptualized and designed the study, and reviewed and revised the manuscript. CFB conceptualized and designed the study, designed the data collection instruments, collected data, and reviewed and revised the manuscript. JL, AG, and RS designed the study, collected data, reviewed, and revised the manuscript. JRS designed the study, reviewed, and revised the manuscript. Multimedia Appendix 1 Voxel Bay video experience. [MP4 File (MP4 Video), 23MB-Multimedia Appendix 1] Multimedia Appendix 2 CONSORT-EHEALTH checklist (V 1.6.1). [PDF File (Adobe PDF File), 82KB-Multimedia Appendix 2] References 1. Mahat G, Scoloveno MA, Cannella B. Comparison of children's fears of medical experiences across two cultures. J Pediatr Health Care 2004;18(6):302-307. 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Coping strategies, pain, and disability in patients with hemophilia and related disorders. Arthritis Rheum 2001 Feb;45(1):48-55 [FREE Full text] [doi: 10.1002/1529-0131(200102)45:1<48::AID-ANR83>3.0.CO;2-1] [Medline: 11308061] 9. Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, et al. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev 2013 Oct 10(10):CD005179. [doi: 10.1002/14651858.CD005179.pub3] [Medline: 24108531] 10. Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, et al. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol 2014 Sep;39(8):783-808 [FREE Full text] [doi: 10.1093/jpepsy/jsu029] [Medline: 24891439] 11. Depledge MH, Stone RJ, Bird WJ. Can natural and virtual environments be used to promote improved human health and wellbeing? Environ Sci Technol 2011 Jun 01;45(11):4660-4665. [doi: 10.1021/es103907m] [Medline: 21504154] 12. Faber AW, Patterson DR, Bremer M. Repeated use of immersive virtual reality therapy to control pain during wound dressing changes in pediatric and adult burn patients. J Burn Care Res 2013;34(5):563-568 [FREE Full text] [doi: 10.1097/BCR.0b013e3182777904] [Medline: 23970314] 13. Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav 2006 Apr;9(2):207-212. [doi: 10.1089/cpb.2006.9.207] [Medline: 16640481] 14. Hoffman HG, Meyer WJ, Ramirez M, Roberts L, Seibel EJ, Atzori B, et al. Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Cyberpsychol Behav Soc Netw 2014 Jun;17(6):397-401 [FREE Full text] [doi: 10.1089/cyber.2014.0058] [Medline: 24892204] 15. Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain 2001 Sep;17(3):229-235. [Medline: 11587113] 16. Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, et al. Water-friendly virtual reality pain control during wound care. J Clin Psychol 2004 Feb;60(2):189-195. [doi: 10.1002/jclp.10244] [Medline: 14724926] 17. Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain 2008 May;24(4):299-304. [doi: 10.1097/AJP.0b013e318164d2cc] [Medline: 18427228] 18. Hoffman HG, Patterson DR, Soltani M, Teeley A, Miller W, Sharar SR. Virtual reality pain control during physical therapy range of motion exercises for a patient with multiple blunt force trauma injuries. Cyberpsychol Behav 2009 Feb;12(1):47-49. [doi: 10.1089/cpb.2008.0056] [Medline: 19018695] 19. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist 2005 Oct;4(4):287-291. [doi: 10.1002/pst.185] 20. Kipping B, Rodger S, Miller K, Kimble RM. Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial. Burns 2012 Aug;38(5):650-657. [doi: 10.1016/j.burns.2011.11.010] [Medline: 22348801] 21. Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs 2012 Dec;27(6):652-681. [doi: 10.1016/j.pedn.2011.08.001] [Medline: 21925588] 22. Li A, Montaño Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag 2011 Mar;1(2):147-157 [FREE Full text] [doi: 10.2217/pmt.10.15] [Medline: 21779307] 23. Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, et al. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma 2011 Jul;71(1 Suppl):S125-S130 [FREE Full text] [doi: 10.1097/TA.0b013e31822192e2] [Medline: 21795888] 24. Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev 2010 Dec;30(8):1011-1018. [doi: 10.1016/j.cpr.2010.07.001] [Medline: 20691523] 25. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken) 2011 Nov;63 Suppl 11:S240-S252 [FREE Full text] [doi: 10.1002/acr.20543] [Medline: 22588748] 26. Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia 1976 Nov;31(9):1191-1198 [FREE Full text] [Medline: 1015603] 27. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 1990 Aug;13(4):227-236. [Medline: 2197679] https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 10 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al 28. Palermo TM. Evidence-based interventions in pediatric psychology: progress over the decades. J Pediatr Psychol 2014 Sep;39(8):753-762 [FREE Full text] [doi: 10.1093/jpepsy/jsu048] [Medline: 24996921] Abbreviations HA: hemophilia A HB: hemophilia B HMD: head-mounted display HTC: Hemophilia Treatment Center IV: intravenous SOC: standard of care VAS: visual analog scale VR: virtual reality Edited by G Eysenbach; submitted 01.05.18; peer-reviewed by C Basch, CH Chan; comments to author 05.08.18; revised version received 25.09.18; accepted 25.09.18; published 09.01.19 Please cite as: Dunn A, Patterson J, Biega CF, Grishchenko A, Luna J, Stanek JR, Strouse R A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial JMIR Serious Games 2019;7(1):e10902 URL: https://games.jmir.org/2019/1/e10902/ doi: 10.2196/10902 PMID: 30626567 ©Amy Dunn, Jeremy Patterson, Charmaine F Biega, Alice Grishchenko, John Luna, Joseph R Stanek, Robert Strouse. Originally published in JMIR Serious Games (http://games.jmir.org), 09.01.2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Serious Games, is properly cited. The complete bibliographic information, a link to the original publication on http://games.jmir.org, as well as this copyright and license information must be included. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 11 (page number not for citation purposes) XSL FO RenderX http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JMIR Serious Games JMIR 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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JMIR Publications
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2291-9279
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10.2196/10902
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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. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al 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) (JMIR Serious Games 2019;7(1):e10902) doi: 10.2196/10902 KEYWORDS anxiety; distraction; hemophilia; intravenous; mobile phone; needle; pediatric; virtual reality low-cost HMDs, at around US $800 for the smart device and Introduction approximately US $35 for HMD. In either case, these estimates do not include the cost of content or technical support to Medical procedures involving needles induce fear in most configure and maintain the systems. Additionally, the unit is people, especially children [1-6]. However, treatment for some tethered to the personal computer and, as a result, cannot easily medical conditions requires frequent needle sticks. Balancing move between locations. Infection concerns exist with the treatment needs for life-threatening conditions with the fear nondisposable headsets particularly in a pediatric setting, such and anxiety imposed by the mechanism of these treatments is as a hematology or oncology clinic. Additionally, most an important challenge for the medical community. In addition commercial VR platforms do not allow a medical provider to to the load needle sticks impose on patients and families, the direct or modify the VR environment in response to patient medical system and medical providers also bear burden and distress and also focus on the experience of patients and not of expenses related to needles. One of the conditions that requires caregivers. the most needle-intensive care is hemophilia. Both hemophilia A (HA) and B (HB) are severe congenital bleeding disorders. Despite the barriers to VR implementation described above, we Without intravenous (IV) infusions of clotting factor hypothesized that a children’s hospital-based team with expertise concentrates, children with hemophilia experience life- and in hemophilia patient care and user experience technology could limb-threatening bleeding. Most children with hemophilia begin create a safe and clinically feasible VR ecosystem that met the routine IV infusions of factor concentrate between the age of 1 needs of patients, caregivers, and medical providers during IV and 3 years and continue infusions 2-3 times per week for life. procedures. Assessing safety and testing the feasibility of the This translates to thousands of necessary needle sticks over the designed ecosystem in a complex clinical environment were course of their lives and a high treatment burden related to the goals of the project. A comprehensive hemophilia clinic needles [7]. Needle fear related to IV procedures, particularly visit was selected to test the safety, feasibility, and likeability in children with hemophilia, can progress to of the ecosystem. During these visits, patients see multiple blood-injection-injury phobia (needle phobia), treatment providers in addition to having IV procedures, so the efficiency avoidance, and poor adherence, all of which can contribute to of clinic flow is vitally important. We specifically designed the poor medical outcomes [8]. Psychological interventions, such ecosystem for children with hemophilia because patients with as distraction and hypnosis, can reduce needle-related pain and hemophilia need a frequent distraction from needles safe and distress in pediatrics [9]. A recent systematic review and successful integration into a complex clinic environment would meta-analysis demonstrated that distraction could lead to demonstrate the likelihood of feasibility in less complex reductions in child- and observer-reported pain and distress situations. during needle procedures. However, among the major elements of distraction, the relative importance of (1) no or low-tech Methods versus high-tech distracters; (2) child engaging versus passive distracters; (3) degree of adult involvement; and (4) the Virtual Reality Platform Design availability of child choice in the success of these distracters is The VR platform design team consisted of the Nationwide unclear [10]. Specific virtual reality (VR)-based distractions Children’s Hospital Hemophilia Treatment Center (HTC) staff have shown promise in clinical settings, such as dentistry, IV and the user experience technology team. The HTC staff placement, occupational or physical therapy, and burn care included a hematologist, nurse clinicians, a social worker, and [9,11-24]. In particular, VR approaches have demonstrated a psychologist. The user experience team included a project decreased pain associated with dental procedures, physical lead, industrial designer, and 2 game designers, 1 of which also therapy, and burn dressing changes. Although various served as the illustrator and visual designer. The team designed consumer-grade VR technologies are available, most carry the platform for boys and girls aged 6-18 years with HA or HB. barriers that prevent clinical implementation [11-18,20-24]. Ideal features were identified through reoccurring meetings, Cost is another barrier, with the top-selling commercial unit which included observation of HTC visits and IV procedures. having an approximate cost of US $500. This includes the Specific platform design needs were identified. First, the cost head-mounted display (HMD), wireless controllers, and of the overall system needed to be low. The system needed to proximity sensors, but not a personal computer capable of be technically easy to implement and maintain for the nursing running VR content, with a cost of approximately US $2000. team. Games needed to be pediatric friendly but of sufficient On the low end, VR content is available for smartphones and https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al quality to maintain the interest of patients and families. Study Design, Patients, and Randomization Additionally, the video content needed to limit the possibility A prospective, monocentric, unblinded, randomized clinical of VR sickness. Importantly, the majority of IV infusions require trial was performed (Clinical Trials.gov NCT03507582). that the medical team has easy access to the hands and arms of Multimedia Appendix 1 provides details of the trial protocol. a patient. This meant that game control mechanics needed to After Institutional Review Board approval, children with HA be hands free and help ensure the patient remained still. Because or HB, aged 6-18 years, who were cared for in our HTC were medical care is fluid and each patient experience is unique, the screened for eligibility. Eligible patients had to be seen for a design team needed to allow the medical team to orchestrate comprehensive HTC visit defined as seeing >3 specialty the patient experience in the real-time to meet individual needs. hemophilia providers during one visit and have a clinically We also sought ways to include caregivers in the game indicated IV laboratory draw or factor infusion. Patients seen experience because parental anxiety around IV procedures can between July 1 and December 31, 2016, were eligible for contribute to poor outcomes, and family-centered care is an participation if they and their parents or guardians could speak important tenet of pediatric care. The team was also mindful of and write in English. Patients who were unable to use the VR the need of the system to minimize the risk of transmitting equipment (visual, cognitive, or hearing impairment that infections agents from any game component. Each element of precluded engagement with the VR environment), who had a the ecosystem—the HMD, games, and the orchestration—was known history of severe motion sickness, or uncontrolled refined with input from volunteer pediatric hemophilia nurse seizures were not eligible (n=1). Those who met screening clinicians, pediatric hematologists, and children without criteria were approached for participation (n=25). A hemophilia hemophilia. The ecosystem components were also demonstrated nurse obtained paper informed consent and age-appropriate at hemophilia community events, and patients with hemophilia assent. Enrolled patients were block randomized by and their families gave feedback to the design team. The final computer-generated random allocation to study groups using a VR intervention used for the clinical trial consisted of custom, prespecified seed. The nurse performing randomization was cordless, multisized, disposable headsets, which enabled the blinded to group allocation. Recruited participants were use of VR through iPod Touch, and immersive custom games randomly assigned using a 2:1 ratio to VR or standard of care with hands-free navigation. Navigation techniques included (SOC) distraction with a stratified block design to maintain age head glances and breath. The mechanism for nurse orchestration strata of 12 patients aged 6-12 years and 12 patients aged 13-18 (Figure 1; Multimedia Appendix 1) was software running on years. SOC distraction was any technique routinely available an iPad dashboard that wirelessly communicated to iPod Touch. in the hematology clinic that did not include VR (ie, smart The orchestration dashboard offered a suite of tools allowing a devices, bubbles, and videos). nurse to respond to patient needs by deploying mini-games or Study Intervention providing relocation to a new setting in the VR ecosystem. The dashboard also allowed parents to monitor their child’s progress. All enrolled patients had a clinically indicated IV procedure. A Moreover, an expert practitioner could observe patient state procedure timer and survey instruments were incorporated into and, upon noticing stress, could trigger an intervention to act the orchestration iPad. A modified visual analog (VAS)/FACES as a distraction method. The system’s communication platform (Figure 2) rating scale was used to assess the distraction utilized an internal server as a relay between the dashboard and techniques. The scale did not undergo specific psychometric the iOS device, which ran VR activities. All signal messages testing; however, the FACES scale is routinely used in our passed through the intermediary system and were logged and hemophilia clinic. A unipolar, horizontal scale was employed tracked against the identifier for the orchestrated session and to increase understandability, uniformity, and sensitivity [25-27]. the type of orchestration command. Message types recorded All participants, caregivers, and nurses (raters) were educated included commands to enter or exit a mini-game, transport the in how to use the VAS/FACES scale prior to beginning the patient to a virtual location, connect to a paired iOS device, study procedure by sliding a bar below the scale picture in adjust the volume, open the video feed from the iOS device’s response to an anchored question. Raters were not blinded to camera, and calibration of the headset units for fit and viewing participant’s distraction group, and each rater answered the preference. After finalization of the platform, safety and study questions independently. Immediately before the IV feasibility of platform integration into a routine comprehensive procedure, children in the VR group were introduced to the HTC visit were explored. Comprehensive visits included care headset, game options, and navigation techniques. Then, before from multiple providers during a specified timeframe, and being positioned for the procedure, each patient, a caregiver anything that impeded clinic flow was judged not feasible. The with them for the procedure, and a hemophilia nurse assessed complexity of the care for patients with hemophilia is reflected the participant’s level of preprocedural anxiety using a in the number and diversity of providers available in each HTC (VAS)/FACES scale answering the question: How worried or clinic. Patients are seen for comprehensive care visits once or nervous is or are you or your child or your patient about the IV twice per year and during those visits are seen by numerous procedure? Sliding the bar to the left (toward 0) represented a providers based on individual needs. This can include low degree of preprocedural worry or nervousness and to the hematologists, nurse clinicians, research nurses, psychologists, right (toward 100) represented the highest degree of nervousness social workers, physical therapists, nutritionists, orthopedists, or worry. The terms nervous and worry were substituted for dentists, genetic counselors, radiologists, advocacy coordinators, anxiety owing to the young age of many participants. After and phlebotomy staff. For the pilot study, the length of the IV being positioned for the procedure, patients in the SOC group procedure time was chosen as a surrogate marker of feasibility. used whatever distraction they preferred, whereas patients in https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al the VR group put on the headset, launched the game of their comprehensive HTC visit. Safety concerns included discomfort choice, and explored the VR environments. The nurse clinician from HMD, infection, and VR sickness. Barriers to feasibility was located next to the patient and deployed VR orchestration that were assessed included technical issues with the set-up or tools as she deemed necessary. The guardian was present orchestration. The primary surrogate marker of feasibility was throughout in both the groups. The study methodology was not the duration of the IV procedure in both study groups. Procedure altered during the trial. No revisions to the VR platform were time was the length of time from the moment a patient was performed or required during the trial. positioned for the procedure to the completion of the procedure, and the primary and secondary outcomes did not change during Primary Outcome the course of the trial. No VR platform performance issues or The primary aim of the study was to assess safety concerns and unexpected events related to the platform were encountered feasibility of integration of the VR platform into a during the trial. Figure 1. Manual orchestration of child engaging events in a virtual reality environment from a connected virtual digital interface from an embedded viewpoint. Figure 2. An example of the modified visual analog/FACES scale. VR: virtual reality. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al internal quality checks. Demographic data were captured from Secondary Outcomes the patients’ electronic medical records. All demographic and Effectiveness of the Distraction Technique safety data were described using summary statistics. To evaluate Both patient groups assessed the effectiveness of their distraction the hypothesis that the procedure time would be similar between techniques following the procedure by answering 3 questions the intervention and SOC groups, Mann-Whitney test was used. as follows. (1) “Did the distraction technique keep you/your The length of IV procedure time was summarized by presenting child /your patient engaged?” The anchors were 0=It really kept mean and corresponding 95% CI as well as median and range. them engaged and 100=It really did not keep them engaged; (2) Kruskal-Wallis tests were applied to compare VAS/FACES “Do you think the distraction technique/s changed you/your scores given by the 3 rater groups as the secondary aim. Scores child/your patient’s nervousness/anxiety level during the IV for the rater groups were summarized with medians and ranges. procedure?” The anchors were 0=it decreased Statistical analyses were performed using the base R statistical nervousness/anxiety a lot and 100=it increased package (R Foundation for Statistical Computing, Vienna, nervousness/anxiety a lot; (3) “How did the distraction Austria). technique/s affect pain during your/your child/your patient’s IV procedure?” The anchors were 0=it made pain a lot better Results and 100=it made pain a lot worse. Demographics Usability and Likeability In this study, 26 patients were screened for enrollment. There For patients randomized to the VR arm, data on the use of the was 1 screen failure in a patient with moderately controlled VR equipment were recorded by the nurse orchestrator at the seizures; therefore, 25 eligible patients aged 6-18 (median age, end of each procedure. Data were categorized if a participant 13) years participated in study (Figure 3). In total, 16 patients wore the VR equipment: (1) during the entire procedure; (2) were randomized to VR and 9 to SOC group; 1 patient in the part of the procedure; or (3) only prior to the procedure. In VR arm was excluded from the analysis because of inability to addition, participants were asked to rate the usability of the VR wear the HMD over glasses. Of the remaining 24 patients, 83% equipment using the VAS/FACES scale to answer “How easy (20/24) participants were males and 17% (4/24) were females; was it for you/your child/your patient to use the VR equipment?” 54% (13/24) had HA and 46% (11/24) had HB, 42% (10/24) A score of 0 represented “really easy to use,” and a score of 100 had severe hemophilia, 58% (14/24) had nonsevere hemophilia, correlated with “really hard to use.” Lastly, participants were and 54% (13/24) were on routine prophylaxis (Table 1). No asked to use the VAS/FACES scale to assess the VR likeability patient harms or unintended effects were seen in either the SOC by answering “How much would you/your child/your patient or VR group. like to use VR for future IV procedures?” A score of 0 equated to “they would really like to use VR again” and 100 meant “they Outcomes would really not like to use it again.” Safety Statistical Analysis No adverse events occurred during the trial. No patient experienced VR sickness, seizures, discomfort from the HMD, This was a pilot feasibility study in a rare population. With or infection-related events related to the VR experience. insufficient background data on the overall feasibility of using VR technology in a clinical setting, a sample of 24 patients was Procedure Time selected to collect pilot data on the safety and usability, logistical The median procedure time was 10 (range 1-31) minutes in the issues of implementation, and to assess the durability and VR group, and was similar to 9 (range 3-20) minutes in the SOC adaptability in the design of the equipment. The study was group (P=.76; Table 1). The mean procedure time was 12.3 designed to be randomized and include a control SOC group to minutes (95% CI 7.2-17.4) in the VR group and 10.1 minutes perform a preliminary test on the hypothesis that the length of (95% CI 5.7-14.6) in the SOC group. time for IV procedures would be similar between the groups, but the sample size did not allow testing for equivalence. The Virtual Reality Equipment Usability justifications for this sample size were based on the rationale In this study, 60% (9/24) patients wore VR equipment during about feasibility, obtaining adequate precision on numerical their entire procedure, 27% (4/24) utilized VR for part of their estimates, and regulatory considerations [19]. This sample size procedure, and 13% (2/24) only used VR prior to the procedure. allowed for evaluating the potential utility of the VR distraction Of the 4 participants who used VR for a part of their procedure, technique on a wide range of ages and would result in parameter 1 removed the headset after the IV stick, while 3 used VR at estimates that would aid in adequately powering future studies the beginning of their procedures, removed the headset to watch that would directly assess the benefits of VR in clinical settings. the IV stick, and then resumed VR. The 2 participants, who Clinical data, including survey instrument data and adverse only used VR prior to their procedures, chose to watch the events, were entered into a hospital-compliant internet data entirety of the IV procedure. No technical issues were noted entry system (REDcap) that included password protection and with the orchestration dashboard, headsets, or game hardware. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al Figure 3. Trial flow diagram. VR: virtual reality. Table 1. Participants’ characteristics and median procedure times. Variable Virtual reality (n=15) Control (n=9) P value Males, n (%) 12 (80) 8 (89) .99 Median age, years 12.2 12.8 .56 Hemophilia type, n (%) .99 Hemophilia A 8 (53) 5 (56) Hemophilia B 7 (47) 4 (44) Hemophilia severity, n (%) .36 Mild 3 (20) 3 (33) Moderate 4 (27) 4 (44) Severe 8 (53) 2 (22) Routine prophylaxis, n (%) 9 (60) 4 (44) .68 Median procedure time, minutes 10 9 .76 Median orchestration events, n 17 N/A N/A N/A: not applicable. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al Table 2. Median pre- and postprocedural visual analog/FACES scale score. Question Virtual reality Nervousness prior to intravenous procedure (0=None, 100=Very) Nurse response 14 Caregiver response 25 Patient response 3 Assessment of the distraction technique Engaged or attentive (0=Yes it did, 100=Did not) Nurse response 13 Caregiver response 13 Patient response 18 Impact on anxiety (0=decreased, 100=increased) Nurse response 3 Caregiver response 15 Patient response 8 Impact on pain (0=lessened, 100=worsened) Nurse response 4 Caregiver response 4 Patient response 3 Likability (0=really like, 100=did not like) Nurse response 1 Caregiver response 4 Patient response 3 Questions for the virtual reality group only Ease of using the virtual reality equipment (0=Easy, 100=Hard) Nurse response 2 Caregiver response 9 Patient response 7 Virtual reality for future intravenous procedures (0=likely, 100=not likely) Nurse response 3 Caregiver response 8 Patient response 12 The VR equipment usability was favorably scored (0=easy to preference, was available for 13 of the 15 patients. A server use, 100=hard to use) with median scores of 7, 9, and 2 by storage issue led to data loss, resulting in missing orchestration participants, guardians, and the nurse, respectively (Table 2). data for 2 patients. In the remaining 13 patients, there were a Additionally, patients, caregivers, and nurses positively rated median of 17 orchestration events (range 7-28) per procedure. the desire to use VR for future procedures on a scale of 0 (would Nervousness or Worry and Pain really like to use VR again) to 100 (would really not like to use The groups did not differ statistically in preprocedural VR again); in majority (36/45, 80%) of evaluations, children, nervousness or worry, as rated by the participant (P=.67), caregivers, and nurses reported that they would like to use VR caregiver (P=.37), or nurse (P=.27; Table 2). Median for future procedures (score <50). nervousness rating for the VR group was 3 (range 0-94) and 12 Orchestration Events for the SOC group (range 0-100). Preprocedural patient The number of deliberate orchestration events per patient, nervousness did differ between age groups (P=.002) with those including commands to enter or exit a mini-game, transport the aged 6-12 years (median 50, range 0-100) being significantly player patient to a virtual location, connect to a paired iOS more nervous compared with those aged 13-18 years (median device, adjust the volume, open the video feed from the iOS 0, range 0-13). Preprocedural patient nervousness did not device’s camera, or calibrate the headset units for fit and viewing statistically differ between those on and not on prophylaxis https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al (P=.64). Median nervousness rating was 6 (range 0-94) for those world elements as the static frame of reference. This execution on prophylaxis and 27 for those not on prophylaxis (range of the technique, therefore, did not sacrifice the immersive 0-100). Both groups favorably viewed distraction techniques quality of the environment. In addition, the static frames in terms of the effect on procedural anxiety, with median introduced a form of kinesthetic reinforcement for the players’ responses being 8 for the VR group and 10 for the SOC group physical sensation to the virtual world, thus lending to their (0=the distraction technique decreased anxiety and 100=the immersive quality. For example, in the snorkeling game in the technique increased anxiety). Both VR and SOC distraction game world, players observed a projection of a virtual diving techniques had a positive influence on procedural pain (0=made mask in their game view. The projection not only acted as a pain better, 100=made pain worse); no statistically significant static frame of reference that thematically fits within the game differences were observed between raters in the VR or SOC environment but also created a relationship between the physical groups (Table 2). sensation of the physical HMD and the virtual mask as seen in the game world. Level of Engagement Our environments incorporated a core component of distraction Scores of participants, nurses, and caregivers did not theory most significantly, with affordance of control and choice significantly differ between VR and SOC distraction techniques as a means to distract [28]. This method is inherent in child in terms of the ability to engage and hold attention (0=held engaging games, with our platform bringing this method to the attention and was engaging and 100=did not hold attention and patient population through hands-free game controls and thus was not engaging; Table 2). representing the first set of pediatric-focused games, which utilize this technique while not requiring hand movement to Discussion interact and thus bringing this technique via games to patients receiving IV procedures. In total, the techniques employed Principal Findings throughout our ecosystem resulted in games that apply This study represented the first known effort to translate VR distraction theory through child engaging VR environments from a research environment to a functioning pediatric clinic while not triggering simulator sickness in participants, as environment as a comprehensive platform including custom demonstrated in the collected data. content (games), tools, and hardware (HMDs). The final platform included a high-tech, VR-based, child engaging Pain and anxiety related to procedures is a concern for patients, distraction with child choice incorporated into a platform that families, and providers, particularly in pediatric settings. allowed for need-based adult involvement. The final HMDs Because children with hemophilia have frequent needle were multisized, lightweight, and disposable and had an procedures, they represent a population that could really benefit estimated unit cost of less than US $55. If manufactured at scale, from VR-based distraction. While there is strong evidence for the estimated cost of the headphones, headsets, lenses, the success of distraction during pediatric procedures, it remains cardboard, elastic, and hooks and loops is less than US $20. unclear which of the 4 main elements of effectiveness (high vs HMDs accommodated 2 distinct size faces—one for average no or low tech, child engaging vs passive, degree of adult face size of patients over 15 years of age and another for that involvement, and availability of child choice) contribute to the of patients under 15 years of age. The game navigation was success of the technique [9,10]. Encouragingly, 87% of hands-free and wireless. Games produced were designed to participants wore the VR equipment during some or all of their appeal to a wide age range of male and female patients. Games procedure, and overall scores regarding the impact of VR on were also engineered to achieve a consistent 30 frames per pain, anxiety, usability, likeability, and level of engagement second playback rate on limited resource devices. Additionally, were favorable. games afforded the player control over a child engaging Limitations gameplay environment without requiring the use of the patients’ The trial was limited by small sample size and single-institution hands—a unique affordance ingrained in this platform. The design. Additionally, we studied only a single intervention, so system achieved hands-free gameplay via the introduction of we were unable to test if the VR platform would continue to proprietary hardware in the custom HMD, which is capable of perform well with future use in the same patient. The study was monitoring the breathing of the play and providing this feedback underpowered to evaluate the equivalence of procedure time. to the games. The system did not require a high-end computer The study was also underpowered to compare VR versus SOC or technical expertise for installation, and the orchestration attributes, but the majority of caregivers and providers had features allowed for customization to patient needs and family favorable ratings of VR, and 80% of participants, all of whom engagement. Successful incorporation into the clinic was had previous experience with SOC distraction in our clinic, demonstrated by the lack of safety and technical issues. reported a desire to use VR for future procedures. The outcomes Although our sample size did not allow equivalence comparison, related to pain and anxiety were self-reported. Addition of we had similar lengths of procedure times in both groups. objectives measures of distress, such as blood pressure and heart The games themselves mitigated the risk of the player rate, would strengthen future studies. developing simulator sickness with the standard technique of Conclusions introducing a static frame of reference during periods of motion. While static frames of reference are a conventional technique We demonstrated that a custom-designed VR platform could used to prevent VR sickness, the technique’s manifestation in be used safely during IV procedures in a pediatric hemophilia our system was novel in approach in that the technique utilized https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Dunn et al population with specific design needs. These results warrant the degree to which adult involvement impacts successfulness; future exploration to assess the impact of our platform on its (3) the importance of the availability of child choice in ability to reduce the burden of IV procedures on patients, distracters; (4) ability to decrease procedural chemical sedation; parents, and clinical care providers. Future studies will be and (5) cost. Additionally, nonrandomized trials allowing needed to validate our findings in other disease populations, children to choose their distraction technique of choice during clinical settings, and institutions with larger participant numbers. procedures would generate useful information. The inclusion While patients with hemophilia may have more IV experiences of objective measures of pain and anxiety would strengthen than most children, it is likely that the positive effects of future studies. This study suggests that a custom VR ecosystem high-quality distraction would be generalizable to IV procedures with clinician orchestration is a promising modality to provide in any pediatric population. We plan larger studies comparing distraction during IV procedures in pediatrics with the potential (1) our child engaging platform versus a passive distracter; (2) to mitigate the perception of procedural pain and anxiety. Acknowledgments The authors would like to thank the patients and staff of the Nationwide Children’s Hospital HTC in Columbus, Ohio, for their support and participation. Additionally, we thank Ms Beth Burkhart, MBA, for assistance with the development and maintenance of the REDcap database, Ms Jessie Haines for administrative support, Mr Roy Goudy for video assistance, and Dr Michael Dunn for critical review of the manuscript. This study was funded by Ohio State University Center for Clinical and Translational Science/Nationwide Children’s Hospital Research Information Solutions & Innovations Voucher #3796: UL1TR001070 and The National Hemophilia Foundation Nursing Excellence Award. Conflicts of Interest AD reports grants, personal fees, and nonfinancial support from Bayer, CSL Behring, Pfizer, Shire, and Hema Biologics; grants and personal fees from Bioverativ; personal fees and nonfinancial support from Medscape and NovoNordisk; and grants from Alnylam and Octapharma during the conduct of the study, and other from Little Seed Inc outside the submitted work. JP reports grants from The Ohio State University, outside the submitted work. JL reports grants from The Ohio State University, during the conduct of the study. CFB reports personal fees from Shire. JRS, AG, and RS have no conflict of interest to declare. 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J Pediatr Psychol 2014 Sep;39(8):753-762 [FREE Full text] [doi: 10.1093/jpepsy/jsu048] [Medline: 24996921] Abbreviations HA: hemophilia A HB: hemophilia B HMD: head-mounted display HTC: Hemophilia Treatment Center IV: intravenous SOC: standard of care VAS: visual analog scale VR: virtual reality Edited by G Eysenbach; submitted 01.05.18; peer-reviewed by C Basch, CH Chan; comments to author 05.08.18; revised version received 25.09.18; accepted 25.09.18; published 09.01.19 Please cite as: Dunn A, Patterson J, Biega CF, Grishchenko A, Luna J, Stanek JR, Strouse R A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial JMIR Serious Games 2019;7(1):e10902 URL: https://games.jmir.org/2019/1/e10902/ doi: 10.2196/10902 PMID: 30626567 ©Amy Dunn, Jeremy Patterson, Charmaine F Biega, Alice Grishchenko, John Luna, Joseph R Stanek, Robert Strouse. Originally published in JMIR Serious Games (http://games.jmir.org), 09.01.2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Serious Games, is properly cited. The complete bibliographic information, a link to the original publication on http://games.jmir.org, as well as this copyright and license information must be included. https://games.jmir.org/2019/1/e10902/ JMIR Serious Games 2019 | vol. 7 | iss. 1 | e10902 | p. 11 (page number not for citation purposes) XSL FO RenderX

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Published: Jan 9, 2019

Keywords: anxiety; distraction; hemophilia; intravenous; mobile phone; needle; pediatric; virtual reality

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