Ethical Challenges of Virtual Reality Technology Interventions for the Vulnerabilities of Patients With Chronic Pain: Exploration of Technician Responsibility.

Chronic pain, a common disease, is a crucial global public health concern. Approximately 20% of the worldwide population is affected by chronic pain, which accounts for 15% to 20% of hospital visits. In Canada, approximately 7.6 million people-or 1 in 5 people-experience chronic pain. Among this population, 60% has either lost their employment or experienced a reduction in income as a result of their pain. The proportion of older people (aged ≥65 years) with chronic pain is high, comprising one-third of the total older population. In addition, the causes of chronic pain and its cures are unknown, and treatment is limited by these unknowns and the dangers of opioids. These essential factors make patients with chronic pain one of the most vulnerable populations. The use of emerging virtual reality (VR) technology as an intervention for chronic pain has consistently demonstrated early effectiveness and has been termed as a "nonpharmacological analgesic." Nevertheless, we must remain vigilant about the potential ethical risks of VR interventions, as inappropriate VR interventions may exacerbate the vulnerabilities of patients. Currently, a central challenge for VR developers is the ambiguity of patient vulnerability and the unpredictability of ethical dilemmas. Therefore, our paper focused on the vulnerability and ethical dilemmas faced by patients with chronic pain in VR interventions. Through an experience-based, prospective ethical examination, we have identified both existing and potential new vulnerabilities and specific manifestations that patients with chronic pain may encounter in VR interventions. Our aim was to highlight the ethical risks that may be present in VR interventions. On one hand, this can help raise awareness among technology developers regarding the vulnerabilities of patients with chronic pain and mitigate technological ethical risks. In addition, it can assist technology developers in determining the priorities for VR technology interventions. These efforts collectively lay a solid foundation for the comprehensive realization of responsible VR technology interventions.

"I Dreamed of My Hands and Arms Moving Again": A Case Series Investigating the Effect of Immersive Virtual Reality on Phantom Limb Pain Alleviation.

Phantom limb pain (PLP) is a type of chronic pain that follows limb amputation, brachial plexus avulsion injury, or spinal cord injury. Treating PLP is a well-known challenge. Currently, virtual reality (VR) interventions are attracting increasing attention because they show promising analgesic effects. However, most previous studies of VR interventions were conducted with a limited number of patients in a single trial. Few studies explored questions such as how multiple VR sessions might affect pain over time, or if a patient's ability to move their phantom limb may affect their PLP. Here we recruited five PLP patients to practice two motor tasks for multiple VR sessions over 6 weeks. In VR, patients "inhabit" a virtual body or avatar, and the movements of their intact limbs are mirrored in the avatar, providing them with the illusion that their limbs respond as if they were both intact and functional. We found that repetitive exposure to our VR intervention led to reduced pain and improvements in anxiety, depression, and a sense of embodiment of the virtual body. Importantly, we also found that their ability to move their phantom limbs improved as quantified by shortened motor imagery time with the impaired limb. Although the limited sample size prevents us from performing a correlational analysis, our findings suggest that providing PLP patients with sensorimotor experience for the impaired limb in VR appears to offer long-term benefits for patients and that these benefits may be related to changes in their control of the phantom limbs' movement.

Designing a Virtual Reality Game for Promoting Empathy Toward Patients With Chronic Pain: Feasibility and Usability Study.

BACKGROUND: Many researchers have been evaluating how digital media may impact the emotional and perspective taking aspects of empathy in both clinical and nonclinical settings. Despite the growing interest in using virtual reality (VR) and VR games to motivate empathy, few studies have focused on empathy for people who live with chronic pain. OBJECTIVE: Chronic pain affects, by conservative estimates, 1 in 5 people in industrialized countries. Despite this prevalence, public awareness of chronic pain was remarkably low until the recent opioid crisis; as a result, stigma remains a problem frequently faced by people who live with this condition. To address this, the VR game AS IF was developed to increase nonpatients' empathy toward the growing number of people who live with long-term chronic pain. On the basis of our prior work, we overhauled our approach, designed and built a VR prototype and evaluated it, and offered design suggestions for future research. METHODS: We introduced the design features of the VR game AS IF and described the study we devised to evaluate its effectiveness. We adopted a mixed methods approach and compared the empathy-related outcomes in both pre- and posttesting. A total of 19 participants were recruited. RESULTS: The findings of this study suggest that the VR game was effective in improving implicit and explicit empathy as well as its emotional and perspective taking aspects. More specifically, for the Empathy Scale, the total pretest scores (mean 47.33, SD 4.24) and posttest scores (mean 59.22, SD 4.33) did not reach statistical significance (P=.08). However, we did find differences in the subscales. The kindness subscale showed a statistically significant increase in the posttest score (mean 15.61, SD 2.85) compared with the pretest score (mean 17.06, SD 2.65;P=.001). For the Willingness to Help Scale, a significant increase was observed from a t test analysis (P<.001) of scores before (mean 7.17, SD 2.28) and after (mean 8.33, SD 2.03) the gameplay. The effect size for this analysis was large (d=-1.063). CONCLUSIONS: The contributions of this research are as follows: AS IF provides a promising approach for designing VR games to motivate people's empathy toward patients with chronic pain, the study evaluates the potential effectiveness of such a VR approach, and the general design suggestions devised from this study could shed light on future VR game systems.

Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial.

BACKGROUND: Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE: This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS: This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS: We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS: A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. TRIAL REGISTRATION: ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323.

Efficacy of a Physical Activity Counseling Program With Use of a Wearable Tracker in People With Inflammatory Arthritis: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of a multifaceted counseling intervention at improving physical activity participation and patient outcomes. METHODS: We recruited people with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). In weeks 1-8, the immediate group received education and counseling by a physical therapist, used a Fitbit and a web application to obtain feedback about their physical activity, and received 4 follow-up calls from the physical therapist. The delay group received the same intervention in weeks 10-17. Participants were assessed at baseline and at weeks 9, 18, and 27. The primary outcome was time spent in moderate/vigorous physical activity (MVPA; in bouts of ≥10 minutes) measured with a SenseWear device. Secondary outcomes included step count, time in sedentary behavior, pain, fatigue, mood, self-management capacity, and habitual behaviors. RESULTS: A total of 118 participants enrolled. The adjusted mean difference in MVPA was 9.4 minutes/day (95% confidence interval [95% CI] -0.5, 19.3, P = 0.06). A significant effect was found in pain (-2.45 [95% CI -4.78, -0.13], P = 0.04), and perceived walking habit (0.54 [95% CI 0.08, 0.99], P = 0.02). The remaining secondary outcomes improved, but were not statistically significant. Post hoc analysis revealed a significant effect in MVPA (14.3 minutes/day [95% CI 2.3, 26.3]) and pain (-4.05 [95% CI -6.73, -1.36]) in participants with RA, but not in those with SLE. CONCLUSION: Counseling by a physical therapist has the potential to improve physical activity in people with inflammatory arthritis, but further study is needed to understand the intervention effect on different diseases. We found a significant improvement in pain, suggesting that the intervention might have a positive effect on symptom management.

Using Physical Activity Trackers in Arthritis Self-Management: A Qualitative Study of Patient and Rehabilitation Professional Perspectives.

OBJECTIVE: To compare and contrast the perspectives of patients with arthritis and those of rehabilitation professionals regarding starting and sustaining use of physical activity trackers (PATs). METHODS: We conducted focus group sessions with patients, physiotherapists, and occupational therapists in Ontario, Alberta, or British Columbia, Canada. To be eligible, patients must have self-reported a diagnosis of inflammatory or osteoarthritis. Rehabilitation professionals reported that at least 40% of their caseload was dedicated to arthritis care. Participants had any level of experience with PATs. A thematic analytic approach was used. RESULTS: The following 3 themes were identified: 1) anticipating sharing objective measures of physical activity. Participants agreed that use of PATs had the potential to improve consultations between patients with arthritis and rehabilitation professionals but were uncertain how to achieve this potential; 2) perceived or experienced barriers to start or continue using a PAT. Participants shared doubts about whether existing PATs would meet specific needs of patients with arthritis and expressed concerns about possible negative impacts; and 3) bolstering motivation? Although there was agreement that use of PATs could bolster the motivation of patients who were already active, patients and rehabilitation professionals had different opinions regarding whether use of PATs alone would motivate patients to start increasing activity levels. CONCLUSION: Our study highlights similarities and differences between the perspectives of patients and rehabilitation professionals regarding the potential value and risks of integrating PATs into arthritis self-management. Despite agreement about the potential of PATs, participants were uncertain how to effectively incorporate these tools to enhance patient-clinician consultations and had differing views about whether use of PATs would support a patient's motivation to be active.

Virtual Reality Clinical Research: Promises and Challenges.

BACKGROUND: Virtual reality (VR) therapy has been explored as a novel therapeutic approach for numerous health applications, in which three-dimensional virtual environments can be explored in real time. Studies have found positive outcomes for patients using VR for clinical conditions such as anxiety disorders, addictions, phobias, posttraumatic stress disorder, eating disorders, stroke rehabilitation, and for pain management. OBJECTIVE: This work aims to highlight key issues in the implementation of clinical research for VR technologies. METHODS: A discussion paper was developed from a narrative review of recent clinical research in the field, and the researchers' own experiences in conducting VR clinical research with chronic pain patients. RESULTS: Some of the key issues in implementing clinical VR research include theoretical immaturity, a lack of technical standards, the problems of separating effects of media versus medium, practical in vivo issues, and costs. CONCLUSIONS: Over the last decade, some significant successes have been claimed for the use of VR. Nevertheless, the implementation of clinical VR research outside of the laboratory presents substantial clinical challenges. It is argued that careful attention to addressing these issues in research design and pilot studies are needed in order to make clinical VR research more rigorous and improve the clinical significance of findings.

A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial.

BACKGROUND: Being physically active is an essential component of successful self-management for people with inflammatory arthritis; however, the vast majority of patients are inactive. This study aims to determine whether a technology-enabled counselling intervention can improve physical activity participation and patient outcomes. METHODS: The Effectiveness of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA) project is a community-based randomized controlled trial with a delayed control design. We will recruit 130 people with rheumatoid arthritis or systemic lupus erythematosus, who can be physically active without health professional supervision. Randomization will be stratified by diagnosis. In Weeks 1-8, participants in the Immediate Group will: 1) receive education and counselling by a physical therapist (PT), 2) use a Fitbit and a new web-based application, FitViz, to track and obtain feedback about their physical activity, 3) receive 4 biweekly follow-up calls from the PT. Those in the Delayed Group will receive the same program in Week 10. We will interview a sample of participants about their experiences with the intervention. Participants will be assessed at baseline, and Weeks 9, 18 and 27. The primary outcome measure is time spent in moderate/vigorous physical activity in bouts of ≥ 10 min, measured with a portable multi-sensor device in the free-living environment. Secondary outcomes include step count, time in sedentary behaviour, pain, fatigue, mood, self-management capacity, and habitual behaviour. DISCUSSION: A limitation of this study is that participants, who also administer the outcome measures, will not be blinded. Nonetheless, by customizing existing self-monitoring technologies in a patient-centred manner, individuals can be coached to engage in an active lifestyle and monitor their performance. The results will determine if this intervention improves physical activity participation. The qualitative interviews will also provide insight into a paradigm to integrate this program to support self-management. TRIAL REGISTRATION: Date of last update in ClinicalTrials.gov: September 18, 2015. ClinicalTrials.gov Identifier: NCT02554474.

A Virtual Reality Game for Chronic Pain Management: A Randomized, Controlled Clinical Study.

Although Virtual Reality (VR) applications have been shown to reduce many forms of acute pain, such research of VR applications and their effects on chronic pain is still at its infancy. In this study, we designed a VR game Cryoslide, and examined its analgesic effect on chronic pain patients, its end users, in a clinical setting. In this randomized, controlled crossover clinical study of 20 chronic pain patients, Cryoslide significantly reduced perceived pain compared to the baseline and the control group. The results demonstrate that Cryoslide can be effectively used as an analgesic intervention for chronic pain management to lessen pain intensity during short-term symptom spikes.

Usability Comparisons of Head-Mounted vs. Stereoscopic Desktop Displays in a Virtual Reality Environment with Pain Patients.

Researchers have shown that immersive Virtual Reality (VR) can serve as an unusually powerful pain control technique. However, research assessing the reported symptoms and negative effects of VR systems indicate that it is important to ascertain if these symptoms arise from the use of particular VR display devices, particularly for users who are deemed "at risk," such as chronic pain patients Moreover, these patients have specific and often complex needs and requirements, and because basic issues such as 'comfort' may trigger anxiety or panic attacks, it is important to examine basic questions of the feasibility of using VR displays. Therefore, this repeated-measured experiment was conducted with two VR displays: the Oculus Rift's head-mounted display (HMD) and Firsthand Technologies' immersive desktop display, DeepStream3D. The characteristics of these immersive desktop displays differ: one is worn, enabling patients to move their heads, while the other is peered into, allowing less head movement. To assess the severity of physical discomforts, 20 chronic pain patients tried both displays while watching a VR pain management demo in clinical settings. Results indicated that participants experienced higher levels of Simulator Sickness using the Oculus Rift HMD. However, results also indicated other preferences of the two VR displays among patients, including physical comfort levels and a sense of immersion. Few studies have been conducted that compare usability of specific VR devices specifically with chronic pain patients using a therapeutic virtual environment in pain clinics. Thus, the results may help clinicians and researchers to choose the most appropriate VR displays for chronic pain patients and guide VR designers to enhance the usability of VR displays for long-term pain management interventions.

A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice.

OBJECTIVES: Immersive virtual reality (IVR) therapy has been explored as an adjunct therapy for the management of acute pain among children and adults for several conditions. Therapeutic approaches have traditionally involved medication and physiotherapy but such approaches are limited over time by their cost and side effects. This review seeks to critically evaluate the evidence for and against IVR as an adjunctive therapy for acute clinical pain applications. METHODS: A rapid evidence assessment (REA) strategy was used. CINAHL, Medline, Web of Science, IEEE Xplore Digital Library, and the Cochrane Library databases were screened in from December 2012 to March 2013 to identify studies exploring IVR therapies as an intervention to assist in the management of pain. Main outcome measures were for acute pain and functional impairment. RESULTS: Seventeen research studies were included in total including 5 RCTs, 6 randomized crossover studies, 2 case series studies, and 4 single-patient case studies. This included a total of 337 patients. Of these studies only 4 had a low risk of bias. There was strong overall evidence for immediate and short-term pain reduction, whereas moderate evidence was found for short-term effects on physical function. Little evidence exists for longer-term benefits. IVR was not associated with any serious adverse events. DISCUSSION: This review found moderate evidence for the reduction of pain and functional impairment after IVR in patients with acute pain. Further high-quality studies are required for the conclusive judgment of its effectiveness in acute pain, to establish potential benefits for chronic pain, and for safety.

Usability testing of ANSWER: a web-based methotrexate decision aid for patients with rheumatoid arthritis.

BACKGROUND: Decision aids are evidence-based tools designed to inform people of the potential benefit and harm of treatment options, clarify their preferences and provide a shared decision-making structure for discussion at a clinic visit. For patients with rheumatoid arthritis (RA) who are considering methotrexate, we have developed a web-based patient decision aid called the ANSWER (Animated, Self-serve, Web-based Research Tool). This study aimed to: 1) assess the usability of the ANSWER prototype; 2) identify strengths and limitations of the ANSWER from the patient's perspective. METHODS: The ANSWER prototype consisted of: 1) six animated patient stories and narrated information on the evidence of methotrexate for RA; 2) interactive questionnaires to clarify patients' treatment preferences. Eligible participants for the usability test were patients with RA who had been prescribed methotrexate. They were asked to verbalize their thoughts (i.e., think aloud) while using the ANSWER, and to complete the System Usability Scale (SUS) to assess overall usability (range = 0-100; higher = more user friendly). Participants were audiotaped and observed, and field notes were taken. The testing continued until no new modifiable issues were found. We used descriptive statistics to summarize participant characteristics and the SUS scores. Content analysis was used to identified usability issues and navigation problems. RESULTS: 15 patients participated in the usability testing. The majority were aged 50 or over and were university/college graduates (n = 8, 53.4%). On average they took 56 minutes (SD = 34.8) to complete the tool. The mean SUS score was 81.2 (SD = 13.5). Content analysis of audiotapes and field notes revealed four categories of modifiable usability issues: 1) information delivery (i.e., clarity of the information and presentation style); 2) navigation control (i.e., difficulties in recognizing and using the navigation control buttons); 3) layout (i.e., position of the videos, text, diagrams and navigation buttons); 4) aesthetic (i.e., the colour, look and feel of the online tool). CONCLUSIONS: Although the SUS score indicated high usability before and after major modification, findings from the think-aloud sessions illustrated areas that required further refinement. Our results highlight the importance of formative evaluation in usability testing.