WO2018209275A1 - Medical-grade virtual reality distraction system and methods of using same - Google Patents

Abstract

Provided herein are disposable VR face pads, hygienic VR face pad kits, and medical grade VR distraction systems that reduce fogging, meet the requirements of hospital-approved infection control protocols, and ensure appropriate body positioning for medical procedures while avoiding abrupt head and/or body movements.

Description

MEDICAL-GRADE VIRTUAL REALITY DISTRACTION SYSTEM

AND METHODS OF USING SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of US 62/505,735 filed May 12, 2017, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] Decreasing pain and stress are universal concerns in the effective management and treatment of pediatric patients in hospitals, clinics, and emergency rooms, and the medical profession is still clearly lacking in appropriate interventions. Sedation and/or anesthesia is obviously too risky, expensive and excessive for most of the more basic and frequent hospital procedures, and systemic pain killers such as opiods present major problems with potential addiction, adverse reactions and decreased long-term efficacy. Thus, it is imperative to identify more appropriate interventions that can be safely and effectively employed on a more frequent basis and for multiple pediatric patients.

[0003] As but one example, children and adolescents with cancer experience frequent pain and distress related to the disease and its treatment. Ljungman et al. , Pediatric Hematology and Oncology 17(3):211-21 (2000). In particular, the insertion of a needle into a subcutaneous port has been shown to be painful, frightening and distressing for children, even when

pharmacological treatments, such as topical anesthetics, are used. Lullmann et al, Eur. J.

Pediatrics 169(12): 1465-9 (2010). Similarly, the vaso-occlusive crisis, or sickle cell crisis, is a common painful complication of sickle cell disease in adolescents and adults, and acute episodes of severe pain are the primary reason for hospital and/or emergency room trips. Yale et al. , Am Fam Physician 61(5): 1349-1356 (2000). For obvious reasons, however, attending physicians are often reluctant to administer adequate dosages of narcotic analgesics to pediatric patients in particular, again because of understandable concerns about addiction, tolerance and side effects.

[0004] Distraction can be efficacious for reducing needle-related pain and distress in pediatric populations (Uman et al , The Cochrane Database of Systematic Reviews, (10) CD005179

(2013)), as well as for managing disease and procedure pain among children and adolescents with cancer. Bukola & Paula, Journal of Pain and Symptom Management, 54(4): 589-600

(2017). Virtual reality (VR) can be a particularly effective distractor given its inherent immersive and interactive properties, and has been shown in research settings to reduce procedure-related pain, fear, anxiety, and distress in children with cancer. Gershon et al , Cyberpsychology & Behavior, 6(6):657-61 (2003); Gershon et al. , Journal of the American Academy of Child and Adolescent Psychiatry 43(10): 1243-49 (2004); Sander Wint et al. , Oncology Nursing Forum 29(1):E8-E15 (2002); Schneider & Workman, Pediatric Nursing 26(6):593- (2000); Windich-Biermeier et al, Journal of Pediatric Oncology Nursing, 24(1):8-19 (2007), Wolitzky et al, Psychology & Health, 20(6):817-24 (2005). Despite positive research reports dating back more than a decade, however, VR distraction has yet to gain significant traction and/or acceptance in the clinic, due in part to safety, hygiene, cost and practical implementation concerns as well as to still-unresolved issues with disruptive patient mobility and other adverse side effects (e.g. dizziness, nausea and/or motion sickness).

[0005] In order for VR distraction to be successful in everyday clinical settings, the VR experience must be delivered without interruption or distractions to ensure the patient receives the maximum VR impact and resultant pain and stress reduction. With conventional VR face pads, the goggles can become fogged, which interrupts the experience such that the patient does not receive the complete therapy. Moreover, for sanitary reasons, the face pads must be disposed of between patients as part of standard hospital-approved infection control protocols. Existing face pads are expensive, are generally not disposable, and are designed for continued use by the same individual over a long time period. Accordingly, there is a need for disposable VR face pads that can meet the requirements of hospital-approved infection control protocols, while simultaneously providing patient comfort and reduced fogging so as not to interrupt VR therapy. Additionally, the VR system and attendant software programming must be such that it ensures appropriate body positioning for medical procedures, and avoids abrupt head and/or body movements. The present invention addresses these and other unmet needs.

BRIEF SUMMARY OF THE INVENTION

[0006] The present invention resolves the foregoing challenges and uncertainties in the art through the provision of medical-grade virtual reality distraction systems, including disposable VR face pad kits for multiple users and complete with appropriate software to ensure appropriate body and head positioning by the patient.

[0007] In one aspect, a disposable face pad for use with a virtual reality (VR) headset is provided, the face pad comprising a plurality of individual layers, wherein the face pad is configured to facilitate air flow into an interior space of the VR headset thereby reducing formation of condensation on an inner surface of the VR headset during use. [0008] In some embodiments, the face pad comprises a first layer facing the VR goggle, a second middle layer, and a third layer facing the user, preferably wherein the individual layers are adhesively connected to each other. In preferred embodiments, the first and third layers comprise a spunlace polyester nonwoven tape. In an exemplary embodiment, the first and third layers comprise 3M product number 1776. In preferred embodiments, the second layer comprises an open-cell foam material. In an exemplary embodiment, the second layer comprises a 3M self-adhering polyurethane foam, e.g. Reston™ foams.

[0009] In some embodiments, the second layer comprises an open-cell foam material having a thickness ranging from about 0.25 inches to about 0.75 inches. In preferred embodiments, the open-cell foam material has a thickness of about 0.5 inches. In some embodiments, the open- cell foam material has a compressive strength ranging from about 75% to about 125% of the compressive strength of RESTON™ foam. In some embodiments, the open-cell foam material has a compressive strength that is equal to the compressive strength of RESTON™ foam.

[0010] In some embodiments, the third layer comprises a soft cloth material that is configured to feel smooth against a user's skin. In some embodiments, the first layer may alternatively comprise a loop material configured to removably adhere to a plurality of hooks on a surface of the VR headset. In an exemplary embodiment, the first layer comprises a polyolefin hook fastener material; e.g. 3M Low Profile Fastener System (product number 7335).

[0011] Also provided are hygienic VR face pad kits for use in a medical grade VR distraction system, said kits comprising: 1) at least one disposable VR face pad configured to facilitate air flow into an interior space of a VR headset, thereby reducing formation of condensation on an inner surface of the VR headset during use, the disposable VR face pad having a) a first layer comprising a spunlace polyester nonwoven tape, b) a second layer comprising an open-cell foam material having a thickness of 0.5 inches and a compressive strength that is equal to the compressive strength of RESTON™ foam; and c) a third layer comprising a soft cloth material that is configured to feel smooth against a user's skin. In some embodiments, the kits may further comprise one or more additional components comprising a disposable hair net; a plurality of disposable headphone covers; and one or more lens cleaning wipes. In some embodiments, the foregoing components are provided in a hermetically-sealed bag.

[0012] In another aspect, medical-grade VR distraction systems are provided comprising at least one disposable face pad or hygienic face pad kit as set forth above, together with a VR headset, a portable VR processor and display device, and a wireless game controller. In preferred embodiments, the portable VR processor and display device is configured to prevent/avoid any network access, external communications and/or any other external input and/or output for HIPP A compliance.

[0013] In preferred embodiments, the portable VR processor and display device comprises software configured to ensure appropriate body positioning for medical procedures, and avoid and/or prevent abrupt head and/or body movements by the patient. In one embodiment, the software presents visual distractors within the VR field (e.g. targets and/or other visual features) primarily or exclusively at or above the eye level of the patient, such that their head position is maintained up and away from the chest area while a medical procedure is taking place. In another embodiment, the software is configured to maintain all visual distractors within the VR visual field primarily or exclusively in front of the patient, with no migration or movement of interaction and/or attention-seeking elements behind the patient that might incentivize the patient to look behind them and thereby trigger torso movement. In another embodiment, the visual field further comprises a rear wall or panel to further discourage the patient from tuming their body to look behind, and optionally further comprising side elements in the visual field (e.g. side arms or the like) directed toward the front and/or center so as to maintain a forward and centered orientation. In another embodiment, the wireless game controller is designed to rest on the patient's lap, so they do not move their arms from side-to-side, also helping to keep the torso flat.

[0014] In another aspect, a method of preventing downward head movement into the chest area during a medical procedure is provided, comprising providing to said patient the subject medical grade VR distraction system detailed herein complete with software configured to present visual distractors primarily or exclusively at or above the eye level of the patient within the VR visual field, outfitting the patient with the appropriate VR components, and operating said VR distraction system simultaneous with performing a medical procedure on said patient such that their head position is maintained up and away from the chest area.

[0015] In another aspect, a method of preventing torso movement during a medical procedure or transport is provided, comprising providing to said patient the subject medical grade VR distraction system detailed herein complete with software configured to maintain all visual distractors within the VR visual field primarily or exclusively in front of the patient, with no migration or movement of the interaction and/or attention-seeking elements behind the patient, outfitting the patient with the appropriate VR components, and operating said VR distraction system simultaneous with performing a medical procedure on or transporting said patient such that their torso is still. In additional embodiments, the visual field presented by the software further comprises a rear wall or panel behind the patient to prevent them from tuming their torso to look behind, and optionally further comprises side elements within the visual field directed and/or pointing forward so as to maintain the patient in a forward and/or centered orientation. In another embodiment, the wireless game controller is designed to rest on the patient's lap, so they do not move their arms from side-to-side, helping keep the torso flat.

[0016] In another aspect, methods of making a face pad for use with a virtual reality (VR) headset are provided, the method comprising: 1) assembling a plurality of medical-grade materials into a stacked configuration, wherein an adhesive is located between at least two of the medical-grade materials in the stacked configuration; 2) applying pressure to the stacked configuration to adhere at least two of the medical-grade materials to one another; and 3) cutting the stacked configuration to make the face pad for use with the VR headset, e.g. performing a die cutting procedure.

BRIEF DESCRIPTION OF THE FIGURES

[0017] Fig. 1 illustrates a preferred embodiment of the disposable face pad according to the subject invention.

[0018] Fig 2. is a graph showing the significant reduction in body areas affected by pain reported by pediatric sickle cell patients before and after the subject VR therapy.

[0019] Fig. 3 is a graph showing the significant reduction in pain intensity reported by pediatric sickle cell patients before and after the subject VR therapy.

[0020] Fig. 4 is a graph showing the significant reduction in pain descriptors reported by pediatric sickle cell patients before and after the subject VR therapy.

[0021] Fig. 5 is a graph showing the significant reduction in simulator sickness and potential side effects reported by pediatric sickle cell patients before and after the subject VR therapy.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Aspects of the invention involve applying VR therapy in a hospital setting with patients undergoing special medical procedures (e.g., bum wound treatment, cancer treatment, sickle cell disease treatment, etc.) and with various medical conditions. To address the problems described above, the subject VR face pads allow the flow of air into the inner space of a VR goggle to reduce fogging and provide a comfortable user experience. Illustrated herein are figures of different non-limiting designs for the subject VR face pads, as well as descriptions of preferred materials that can be used in the construction of the subject VR face pads. In preferred embodiments, a subject VR face pad comprises one or more medical-grade materials.

[0023] Sandwich Design: In some embodiments, a subject VR face pad comprises a

"sandwich" construction that is formed from three layers of medical grade materials that are fixed together with an adhesive and pressure and then die cut to a precise form.

[0024] Airflow: Aspects of the invention include a VR face pad that comprises a foam material whose thickness and firmness levels facilitate unrestricted air flow into the interior space of the goggles, thereby ensuring patient comfort during a VR therapy procedure.

[0025] In one embodiment, the layer facing the goggle (the "first layer") comprises a soft, medical grade non-woven tape material, or alternatively a material that adheres to permanent hooks on the VR goggles. This allows the VR face pads to be placed properly on the goggles, and then easily removed and disposed of after each use by a patient in hospital setting.

Preferably, the first layer comprises a spunlace nonwoven material, more preferably a spunlace polyester nonwoven tape material, e.g. 3M Medical Nonwoven Tape (product number 1776), or alternatively a polyolefin hook fastener material; e.g. 3M Low Profile Fastener System (product number 7335).

[0026] In one embodiment, the middle layer (the "second layer") comprises an open cell (breathable) foam material that allows air to flow through it and gently conforms to the user's face contours to enhance comfort. In some embodiments, the middle layer has a thickness that ranges from about 0.25 inch to about 1 inch, such as about 0.5 inch, or about 0.75 inch. In one preferred embodiment, the middle layer has a thickness of about 0.5 inch. Preferably, the second layer comprises a porous polyurethane foam, e.g. 3M RESTON™ Self-Adhering Foam.

Notably, early prototypes were created using viscoelastic foams, such as 3M Medical

Technologies "Confor Foams". These foams are temperature-responsive so they soften on contact with the skin allowing for a uniform pressure distribution. Although a number of prototypes were explored using different thickness and densities of this alternative material, they all lacked the required breathability needed to keep the goggles from fogging.

[0027] In one embodiment, the layer touching the patient's face (the "third layer") comprises a medical grade soft cloth that feels smooth and comfortable on the skin. Preferably, the third layer also comprises a spunlace nonwoven material, more preferably a spunlace polyester nonwoven tape material, e.g. 3M Medical Nonwoven Tape (product number 1776).

[0028] Nose Bridge: In some embodiments of the invention the subject VR face pads further comprise a nose bridge that cushions the goggles on the bridge of the patient's nose. Prior art face pads frequently leave the bridge of the nose area open, so the hard plastic of the goggles contacts the user's nose, which can cause discomfort. In contrast, the design of the subject VR face pads recognizes that every user has different facial features (which can vary by age, gender, race, weight, etc.) and includes padded coverage over the bridge of the nose area to ensure that all users will find the goggles comfortable.

[0029] Hygienic VR Face Pad Kits: The subject disposable VR face pads are designed to be part of a medical grade VR distraction system appropriate for use in clinical settings with multiple patients and with minimal maintenance and expense between uses. In some embodiments, a face pad is packaged together with a hair net, two headphone covers, and two lens-cleaning wipes, in a single-use poly bag. In use, a medical professional (e.g., a doctor, nurse, or medical technician) can open one single-use bag and have all the hygienic parts conveniently available for use with the VR therapy. This approach is not only convenient, but also adheres to infection control protocols, and serves as a reminder to the medical professional to follow the infection control protocol. In some embodiments, a hygiene system further comprises a label that provides important information, such as lot number tracking, as recommended by the FDA's Good Manufacturing Practices. In some embodiments, a hygiene system is configured for sterilization. In some embodiments, a hygiene system comprises a hermetically-sealed bag that remains sterile following a sterilization procedure.

[0030] Medical Grade VR Distraction System: The hygienic VR distraction systems of the subject invention will further comprise a VR headset (e.g. Samsung Gear VR™ or the like), a portable VR processor and display device (e.g. Samsung Galaxy S6™ or the like), and a wireless game controller (e.g. Moga Pro™ Power controller or the like), along with software that has been customized for specific medical procedures. In an exemplary embodiment, the VR experience is designed for patients undergoing a subcutaneous port access procedure, often used to administer chemo therapy to cancer patients. The experience has been created to help lower stress and pain for the patients undergoing this procedure. It does this by directing patient's attention away for the pain and stress into a virtual world where they are, e.g., underwater scuba divers, searching for treasure, coloring sea creatures and coral, and listening to ocean sounds and relaxing music. The customized elements include a design that encourages patients to keep their torso still to allow for a safe procedure as well as a special "look up" feature where all the distracting elements (fish, sounds, whales, etc.) are above eye level. Therefore, the patient keeps their head up and out of the way of the procedure area, keeping it clean and more easily available to the medical staff. The clinical tests described in more detail herein have demonstrated the efficacy and safety of this novel VR interventional approach. [0031] Aspects of the invention described herein can be performed using any type of computing device, such as a computer, that includes a processor, e.g., a central processing unit, or any combination of computing devices where each device performs at least part of the process or method. In some embodiments, systems and methods described herein may be performed with a handheld device, e.g., a smart tablet, smart watch or a smart phone, or a specialty device produced for the system.

[0032] Methods of the invention can be performed using software, hardware, firmware, hardwiring, or combinations of any of these. Features implementing functions can also be physically located at various positions, including being distributed such that portions of functions are implemented at different physical locations. In some cases, one or more functions are in the same location or on the same computer. In preferred embodiments, the function of generating and displaying the customized VR experience herein is performed on a smart phone or tablet or other suitable device coordinated with a desired VR headset, and is configured without any network or other connection including cellular (e.g. , 3G or 4G), local area network (LAN), and/or wide area network (WAN), e.g., the Internet, or other form of connectivity, for HIPPA compliance purposes.

[0033] Processors suitable for the execution of computer programs include, by way of example, both general and special purpose microprocessors, and any one or more processor of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. Information carriers suitable for embodying computer program instructions and data include all forms of non-volatile memory, including, by way of example, semiconductor memory devices, (e.g., EPROM, EEPROM, solid state drive (SSD), and flash memory devices); magnetic disks, (e.g., internal hard disks or removable disks); magneto-optical disks; and optical disks (e.g., CD and DVD disks). The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.

[0034] To provide for interaction with a user, the subject matter described herein can be implemented on a computer having an I/O device, e.g., a CRT, LCD, LED, or projection device for displaying information to the user (e.g., the VR programming) and an input or output device such as a game controller or pointing device, by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well, and input from the user can be received in any form, including acoustic, speech, or tactile input.

[0035] The subject matter described herein can be implemented as one or more computer program products, such as one or more computer programs tangibly embodied in an information carrier (e.g., in a non-transitory computer-readable medium) for execution by, or to control the operation of, data processing apparatus (e.g., a programmable processor, a computer, or multiple computers) to perform one or more of the methods described herein. A computer program (also known as a program, software, software application, app, macro, or code) can be written in any form of programming language, including compiled or interpreted languages (e.g., C, C++, Perl), and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. Systems and methods of the invention can include instructions written in any suitable programming language known in the art.

[0036] A computer program does not necessarily correspond to a file. A program can be transitory or non-transitory medium that is stored in a file or a portion of a file that holds other programs or data, in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network.

[0037] A file can be a digital file, for example, stored on a hard drive, SSD, CD, or other tangible, non-transitory medium. A file can be sent from one device to another over a network (e.g., as packets being sent from a server to a client, for example, through a Network Interface Card, modem, wireless card, or similar).

[0038] Writing a file according to the invention involves transforming a tangible, non- transitory computer-readable medium, for example, by adding, removing, or rearranging particles (e.g., with a net charge or dipole moment into patterns of magnetization by read/ write heads), the patterns then representing new collocations of information about objective physical phenomena desired by, and useful to, the user. In some embodiments, writing involves a physical transformation of material in tangible, non-transitory computer readable media (e.g., with certain optical properties so that optical read/ write devices can then read the new and useful collocation of information, e.g., burning a CD-ROM). In some embodiments, writing a file includes transforming a physical flash memory apparatus such as NAND flash memory device and storing information by transforming physical elements in an array of memory cells made from floating-gate transistors. Methods of writing a file are well-known in the art and, for example, can be invoked manually or automatically by a program or by a save command from software or a write command from a programming language.

[0039] Suitable computing devices typically include mass memory, at least one graphical user interface, at least one display device, and typically include communication between devices. The mass memory illustrates a type of computer-readable media, namely computer storage media. Computer storage media may include volatile, nonvolatile, removable, and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer storage media include RAM, ROM, EEPROM, flash memory, or other memory technology, CD- ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, Radiofrequency Identification tags or chips, or any other medium which can be used to store the desired information and which can be accessed by a computing device.

[0040] Functions described above can be implemented using software, hardware, firmware, hardwiring, or combinations of any of these. Any of the software can be physically located at various positions, including being distributed such that portions of the functions are

implemented at different physical locations.

[0041] As one skilled in the art would recognize as necessary or best-suited for performance of the methods of the invention, a computer system for implementing some or all of the described inventive methods can include one or more processors (e.g., a central processing unit (CPU) a graphics processing unit (GPU), or both), main memory and static memory, which communicate with each other via a bus.

EXAMPLES

Example 1; Virtual Reality as Complementary Pain Therapy in Hospitalized Patients with Sickle Cell Disease

[0042] The purpose of this study was to evaluate the usability and acceptability of immersive virtual reality technology in sickle cell patients hospitalized with pin, and to determine if the VR experience can serve as an effective adjunctive therapy to traditional pain reduction treatments.

Methods

[0043] Patients with SCD 8 years and older admitted to UCSF Benioff Children's Hospital Oakland with vaso-occlusive pain were offered one 15 minute VR session. Tolerability was evaluated with a brief survey before and after the session. Patient demographic information was collected including age, sex, underlying hemoglobin variant and day of admission that the VR session was administered. The APPT was utilized to measure intensity of pain based on a 0-10 word graphic rating scale, location of pain determined based on circling affected body parts, and qualitative assessment of pain including affective, evaluative, sensory and temporal qualities based on the descriptors of pain circled by the patient. The administered simulator sickness questionnaire and satisfaction survey were based on a 1-10 scale, with the satisfaction survey used to determine how immersive the VR environment felt for the patient, as well as how comfortable and enjoyable the experience was. Values collected for the APPT and simulator sickness questionnaire pre- and post-VR session were analyzed using paired student t-tests.

Results

[0044] Of the 30 enrolled patients, 21 were female with an average age of 16.5 years, with most patients having hemoglobin SS disease. Patients had significant improvement in all aspects of the APPT after the 15-minute VR session. See Figures 2-4. Notably, there was highly significant improvement in pain intensity after the VR session as well as in number of affected areas and qualitative measures of pain. In addition, patients were extremely satisfied with the VR session. The VR software appeared to allow for near total immersion and thus pain distraction. Patients rated both the VR software and headset as comfortable; all patients requested use of the VR system again.

[0045] Notably, there was no evidence of simulator sickness with the VR session. In fact, measures of simulator sickness including headache, upset stomach and dizziness all improved statistically after the VR session. The importance of creating a VR environment that is conducive for distraction and relaxation while minimizing side effects should be emphasized. Kipping et al. showed no benefit in utilization of an "off-the-shelf VR product in the reduction of acute pain for adolescents undergoing burn wound care.

Conclusion

[0046] Immersive VR therapy was universally tolerated in a cohort of patients with SCD admitted for vaso-occlusive pain. VR allowed for a statistical reduction in subjective multidimensional self-assessment of pain after a single session. VR therapy can be easily adapted into pediatric child life programs and has wide applicability beyond chronic pain syndromes including acute pain due to injury, procedural pain as well as anxiety related to medical procedures. Repeated utilization of VR therapy during hospitalization would likely have continued benefit and may have more significant impact on opioid usage and hospital duration. Example 2; Usability and Safety Testing of an Interactive VR Distraction Intervention to Reduce Procedural Pain in Children with Cancer

[0047] The purpose of this study was to use iterative usability testing cycles to refine the VR distraction intervention (hardware and software) for children and adolescents ages 8 to 18 with cancer such that it would be deemed: (1) easy to use, understand, and acceptable according to children and adolescents, (2) able to be implemented within the clinical care environment; and (3) not to cause adverse events (e.g., dizziness, nausea).

Methods

[0048] Sample Selection: A convenience sample of children and adolescents were recruited from an outpatient oncology clinic in a university-affiliated paediatric tertiary care centre in Toronto, Canada. Children and adolescents were deemed eligible if they were: (a) 8 to 18 years old, (b) undergoing cancer treatment and having a SCP access during their current outpatient visit, and (c) able to speak and understand English. Children and adolescents were excluded if they: (a) had visual, auditory or cognitive impairments precluding interaction with the VR intervention; (b) were at the end-of-life; or (c) had a methicillin-resistant Staphylococcus aureus (MRSA) infection or symptoms of respiratory or gastrointestinal infection to avoid

contaminating VR equipment.

[0049] Study Design: A mixed-methods approach using iterative cycles of VR intervention usability testing and revision was conducted. This design was modeled after established usability testing methods for refining new technology based on feedback from end-users (Kushniruk 2002). Based on usability testing recommendations and prior usability testing experience, 2-3 cycles of testing with 5-7 children and adolescents with cancer per cycle were expected to identify all issues with the VR intervention (Jibb et al., 2017; Macefield 2009; Stinson et al, 2013). Testing cycles involved observation by a trained research assistant and semi -structured audio-recorded interviews.

[0050] Study Procedures: This study was approved by the institutional research ethics board. Potentially eligible participants were identified and initially approached by a member of their clinical care team. If the child expressed interest, a research assistant explained the study and obtained written informed consent from the child or parent. Assent was obtained from children whose parents provided informed consent. After providing consent, child demographic and disease-related information was collected by self- or parent-report. Participants were asked to rate their current pain, distress, dizziness, and nausea prior to any use of the VR equipment. Participants were given a ~2 -minute demonstration of the VR hardware and a verbal description of the software.

[0051] In Cycle 1, participants tested the VR intervention prior to their SCP access to ensure safety and potential adverse events. They were asked to "think-aloud" any thoughts or problems they experienced while using the VR. After testing the intervention, the SCP access procedure was conducted. In Cycles 2 and 3, participants used the VR intervention during their SCP access after the safety of the VR program was demonstrated in Cycle 1. Similar to Cycle 1, participants were asked to "think-aloud" any thoughts or problems they experienced while using the VR intervention. The research assistant observed the procedure and took field notes related to any arising issues and impact on clinical workflow.

[0052] Throughout all cycles, participants were instructed to immediately alert the research assistant if they experienced any adverse effects (e.g., dizziness, nausea) while using the VR intervention. The research assistant immediately reported these to the participant's nurse or doctor; however, no adverse events occurred. An oncology nurse performed the SCP access for all participants as per institutional standard of care, which included: (1) performing an assessment for appropriate pain/comfort measures, (2) ensuring that the patient and all those involved in the procedure were wearing masks, (3) manual palpation for 'land marking' of the port entry site, (4) sterilizing the skin, (5) inserting the needle and (6) applying a sterile dressing. The procedure is typically completed within 5-10 minutes. After procedure completion, participants in all cycles completed a 5-minute semi-structured interview regarding usability and acceptability of the intervention. This interview was audio-recorded and transcribed verbatim. Total study participation time was approximately 25 minutes. Children and adolescents received an honorarium for participation.

Measures

[0053] Demographics. Demographic information collected at baseline, included child age, sex, ethnicity, and school grade. Disease-related information included cancer diagnosis, cancer stage/risk stratum, type of cancer treatment (e.g., chemotherapy, radiotherapy etc.), and date of cancer diagnosis.

[0054] Baseline pain and symptoms. Participants rated their pain using an 11 -point numeric rating scale (NRS; 0=no pain at all; 10=most pain you can imagine having), which is a validated measure for pediatric pain assessment (Castarlenas, Miro, & Sanchez-Rodriguez, 2013).

Participants also rated their current distress using an 11 -point NRS (0=no distress at all;

10=most distress you can imagine having). The occurrence of nausea or dizziness was determined using a yes/no question, and if present were asked to rate the degree of nausea or dizziness symptoms as 'not bad at all', 'a little bad', 'bad', or 'very bad'.

[0055] Semi-structured interview. A qualitative semi-structured interview asked children and adolescents about the ease of use, ease of understanding, acceptability ('likes' and 'dislikes'), impact on their experience, and any adverse events the VR intervention. The interview included questions regarding what participants would change about the VR intervention, and whether they would be interested in using it during a subsequent SCP access or needle-related painful procedure. To assess for adverse events, participants were also asked about any nausea or dizziness symptoms experienced during use of the intervention (i.e., adverse events), and any other feelings they experienced (e.g., scared, happy, frustrated, bored, relaxed).

Virtual Reality Intervention

[0056] Hardware: Participants used an adjustable VR that included a stereoscopic display powered by a Samsung smartphone (Galaxy S6TM) that is mounted on a lightweight (345g) wireless off-the-shelf head mounted display with a 101-degree field of view for users (Samsung GearVRTM). A focus wheel on the VR goggles was adjusted to find a comfortable focal length for each participant. Sound was delivered through noise-cancelling headphones (Sony MDR 10R Headphones). A lightweight (295g) wireless Bluetooth controller (MOGA PROTM

POWER controller) that required only one hand to operate was used by the child or adolescent to interact with the VR environment. For infection control reasons and because the same hardware was used for all participants, the hygienic disposable face pads of the subject invention were used on the headphones and head mounted display, and participants wore a hairnet under the hardware.

[0057] Software: The VR intervention included auditory and visual stimuli to simulate travel as a scuba diver through a peaceful underwater environment surrounded by creatures (e.g. , sea turtles, fish, whales) and coral reef (kindVR® AquaVRTM). An interactive game allowed participants to aim projectiles (e.g. rainbow balls) at the underwater creatures passing by as they searched for treasure. Slight head movements allowed participants to explore the environment and aim the rainbow balls, which they could launch by pressing a button on the controller. When hit, underwater creatures turned bright colours. Notably, the software was customized to accommodate patients undergoing a SCP access procedure by programming the game runtime to suit the typical procedure length and ensuring that gameplay interaction minimized torso movement. Data Analysis

[0058] Demographic and disease data were summarized using descriptive statistics. Study objectives were addressed via qualitative data from participants' "think aloud" responses while using the VR equipment, semi-structured interviews, and research assistant field notes. A conventional qualitative descriptive content analysis approach was used to identify usability themes according to study objectives (Hsieh & Shannon, 2005). Categories were generated until all data from the testing sessions were categorized (Patton 2014; Sandelowski 2010). Qualitative data analysis began once the first usability session was conducted to allow issues identified in earlier sessions to inform data collection in later sessions using constant comparative analyses (Bowen 2008; Lingard, Albert, & Levinson, 2008). Two investigators conducted data analyses and discrepancies regarding identified themes were intended to be resolved through discussion with a third investigator; however, no discrepancies occurred. Any issues or refinements to the intervention were addressed and resolved before another testing cycle was initiated. Testing continued for until no further issues were identified.

Results

[0059] Sample Characteristics: In total, 17 eligible children and adolescents participated (n=5 in Cycle 1; n=6 in Cycle 2; and n=6 in Cycle 3). Four additional children and adolescents were approached but declined to participate (n=2 in Cycle 1 and n=2 in Cycle 3). See Table 1 for participant demographic, medical characteristics, and baseline symptoms. Participants had a mean age of 11.7 years (SD=3.4; range = 8-18) and were mostly male (n=12; 70%). The most common cancer diagnoses were acute lymphoblastic leukemia (n=7; 41%) and brain tumour (n=4; 23%). Most participants had been diagnosed within the year prior to study participation (n=12; 70%). All participants were receiving chemotherapy for cancer treatment. Most participants reported no pain or distress at baseline, although a small number reported mild to moderate levels of pain or distress. One participant reported mild nausea at baseline.

[0060] Usability Testing of the VR Intervention

[0061] In Cycle 1, all participants completed usability testing of the VR system prior to the SCP access. In Cycles 2 and 3, all participants used the VR intervention during the SCP access. Based on participant feedback, the VR intervention was adapted following each of the three cycles of usability testing. Themes from usability testing interviews and field notes for all three cycles of VR testing are presented below. See Table 2 for a summary of issues raised during usability testing cycles and corresponding refinements. [0062] Ease of use. Across all cycles, most participants had no difficulties using the VR system. They found the controller easy to use and navigating the VR environment simple. A minority of participants identified issues with ease of use, and certain refinements were made to content in the VR environment (i.e. , reducing speed of the projectile, increasing size of the projectile, and increasing size of the target). Additionally, the VR game content was also placed in the visual field at the user's eye level or above so as to encourage participants to not to look down during the procedure and possibly disrupt the procedure.

[0063] Ease of understanding. Across all three cycles, most participants quickly grasped the objective of the game and how to use the VR controls.

[0064] Acceptability. Most participants felt "happy and relaxed" while using the VR intervention (n=13, 76%), and two participants felt "excited." The majority of participants (n=16, 94%) were interested in using the VR intervention during a subsequent SCP access or another needle procedure. Across all three cycles, participants enjoyed the immersive underwater environment, appreciated the visuals and accompanying music, as well as the ability to independently explore the environment. Participants enjoyed the gamification and being able to interact with the underwater creatures by launching rainbow balls at them. Changes were made to increase continuous interactivity within the VR environment (e.g., more fish and coral, increase colour changes to sea creatures when hit by the rainbow balls launched by the user).

[0065] Implementation in clinical care. Most issues identified regarding implementation of the VR system in clinical were observed by research assistants and/or spontaneously reported by nurses completing the procedure. In all cycles, the research assistants and nurses raised the concern that participants' downward head movements in response to the game caused difficulty for the nurse completing the procedure. This issue was addressed be modifying the software to 1) remove a game scoreboard virtually located on the VR user's arm, requiring them to look down to see it, and 2) placing game content at eye level or above (as described above to also increase ease of use). During Cycles 1 and 2, the research assistant noted the wire connecting the headphones to the VR headset was entering the sterile area during procedure due to head movement by participants during game play. To address this, the wire was taped to the headset to prevent further interference. No further issues with the headphones were reported.

[0066] Adverse events. No adverse events occurred. Although one participant had minimal nausea prior to using the VR and undergoing the SCP access, they did not reported any nausea after. Across all cycles, no participants reported dizziness or nausea following testing sessions.

Discussion [0067] A total of 17 children and adolescents with cancer aged 8-18 years tested the VR intervention either prior to or during a SCP access. Feedback and intervention refinements were made over three iterative cycles of usability testing. Refinement of the VR program in a user- centered manner ensured the intervention is easy to use and understand, and acceptable to children and adolescents within the clinical environment.

[0068] Importantly, no adverse events of nausea or dizziness were reported by participants while using the VR intervention. Such symptoms have been inconsistently reported in prior studies of VR use by children during needle procedures (Gold & Mahrer, 2017; Gold et al., 2006). The VR intervention has the potential to decrease negative impacts of invasive care on children with cancer, improve patient and parent satisfaction, and children's quality of life during their cancer care experience.

[0069] While the present invention has been described with reference to specific embodiments thereof, it should be understood by those skilled in the art that various changes can be made and equivalents can be substituted without departing from the true spirit and scope of the invention. In addition, many modifications can be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

Claims

1. A disposable face pad for use with a virtual reality (VR) headset, the face pad comprising:

a plurality of individual layers, wherein the face pad is configured to facilitate air flow into an interior space of the VR headset, thereby reducing formation of condensation on an inner surface of the VR headset during use.

2. The disposable face pad according to claim 1, wherein the face pad is configured to be removably coupled to the VR headset.

3. The disposable face pad according to claim 1 or 2, wherein the face pad comprises a first layer facing the headset, a second middle layer, and a third layer facing the patient.

4. The disposable face pad according to claim 3, wherein the second layer comprises an open- cell polyurethane foam material, preferably 3M RESTON™ foam.

5. The disposable face pad according to claim 4, wherein the open-cell foam material has a thickness that ranges from about 0.25 inches to about 0.75 inches, preferably about 0.5 inches.

6. The disposable face pad according to claim 4, wherein the open-cell foam material has a compressive strength that ranges from about 75% to about 125% of the compressive strength of 3M RESTON™ foam.

7. The disposable face pad according to any one of claims 3-6, wherein the third layer comprises a spunlace polyester nonwoven tape material configured to feel smooth against a user's skin, preferably 3M product number 1776.

8. The disposable face pad according to any one of claims 3-6, wherein the first layer comprises a spunlace polyester nonwoven tape material, preferably 3M product number 1776, or a loop material configured to removably adhere to a plurality of hooks on a surface of the VR headset, preferably 3M product number 7335.

9. A hygienic VR face pad kit comprising at least one disposable VR face pad according to any one of claims 1-8 in a hermetically-sealed bag.

10. The hygienic VR face pad kit according to claim 9, further comprising one or more of: a disposable hair net;

a plurality of disposable headphone covers; and

one or more lens cleaning wipes.

11. A medical grade VR distraction system comprising a) at least one disposable VR face pad according to any one of claims 1-8 or at least one hygienic VR face pad kit according to any one of claims 9-10; b) a VR headset; c) a portable VR processor and display device; and d) a game controller; wherein the portable VR processor and display device comprises software configured to ensure the appropriate body position of a patient, and prevent abrupt head, body and/or hand movements by the patient.

12. The VR distraction system according to claim 1 1, wherein the software presents visual distractors primarily or exclusively at or above the eye level of the patient within the VR field, such that their head position is maintained up and away from the chest area where a medical procedure is taking place.

13. The VR distraction system according to claim 1 1, wherein the software is configured to allow aiming a proj ectile at an object within the VR visual field solely with the head/eyes? rather than hands, so as to keep the torso still and the patient's hands by their side

14. A method of preventing downward head movement by a patient during a medical procedure, comprising:

providing to said patient the medical grade VR distraction system according to any one of claims 11 -14, wherein the portable VR processor and display device comprises software configured to present visual distractors primarily or exclusively at or above the eye level of the patient within the VR visual field,

outfitting the patient with the appropriate VR components, and

operating said VR distraction system simultaneous with performing a medical procedure on the chest or lower torso of said patient, such that their head position is maintained up and away from the chest area.

15. A method of preventing torso movement during a medical procedure on or transport of a patient comprising: providing to said patient the medical grade VR distraction system according to any one of claims 11-14, wherein the portable VR processor and display device comprises software configured to maintain all visual distractors within the VR visual field primarily or exclusively in front of the patient, with no migration or movement of the interaction and/or attention-seeking elements behind the patient,

outfitting the patient with the appropriate VR components, and operating said VR distraction system simultaneous with performing a medical procedure on or transporting said patient such that the patient is discouraged from turning their torso to look behind.