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Feasibility of implementing a virtual reality program as an adjuvant tool for peri-operative pain control; Results of a randomized controlled trial in minimally invasive foregut surgery
Complementary Therapies in Medicine 49 (2020) 102356
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Complementary Therapies in Medicine journal homepage: www.elsevier.com/locate/ctim
Feasibility of implementing a virtual reality program as an adjuvant tool for peri-operative pain control; Results of a randomized controlled trial in minimally invasive foregut surgery
T
Kelly R. Haisleya,b,c, Olivia J. Strawb, Dolores T. Müllerb, Michael A. Antipordab,d, Ahmed M. Zihnib,e, Kevin M. Reavisb,c, Daniel D. Bradleyb,c, Christy M. Dunstb,c,* a
Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, United States Foundation for Surgical Innovation and Education, Portland, OR, United States Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States d GI Surgical Specialists, Fort Meyers, FL, United States e Denver Esopahgeal and Stomach Center, Denver, CO, United States b c
A R T I C LE I N FO
A B S T R A C T
Keywords: Virtual reality Multimodal pain control Peri-operative management Narcotic utilization
Background: Post-operative pain control and narcotic over-utilization are challenging issues for surgeons in all fields. While virtual reality (VR) has been increasingly applied in various fields, its feasibility and efficacy in the peri-operative period has not been evaluated. The aim of this study was to examine the experience of an integrated VR protocol in the perioperative setting. Methods: Patients undergoing minimally invasive foregut surgery at a single institution were randomized to receive a series of VR meditation/mindfulness sessions (VR) or to standard care after surgery (non-VR). Postoperative pain levels, narcotic utilization and patient satisfaction were tracked. Results: Fifty-two patients were enrolled with 26 in each arm. Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups. For patients in the VR arm, sessions were able to be incorporated into the perioperative routine with little disruption. Most (73.9 %) were able complete all six VR sessions and reported low pain, anxiety, and nausea scores while using the device. A high proportion responded that they would use VR again (76.2 %) or would like a VR program designed for pain (62.0 %). There were no complications from device usage. Conclusion: VR is a safe and simple intervention that is associated with high patient satisfaction and is feasible to implement in the perioperative setting. While the current study is underpowered to detect difference in narcotic utilization, this device holds promise as an adjuvant tool in multimodal pain and anxiety control in the perioperative period.
1. Introduction Post-operative pain and other stressful stimuli remain major hurdles to recovery in all fields of surgery. While opioids have been the mainstay of perioperative pain control for decades, these drugs can expose patients to a risk of dependence and do little to address the fear and anxiety that may also contribute to coping in this stressful period. As the opiate crisis has grown, there has been increasing recognition of the dangers of narcotic overuse and the role that legal narcotic prescribing, frequently by surgeons, has played as the gateway to abuse and addiction.1,2 As a result, there has been considerable work in recent years
to try to identify novel and multimodal approaches to pain and anxiety control to decrease our current dependence on opiates and help to overcome some of the obstacles to a smooth and safe recovery after surgery.3 Virtual reality (VR) has been proposed as an adjuvant patient care tool to try to address pain as well as overall psychosocial stress dynamics that accompany the experience of pain.4,5 VR involves using electronic devices to provide sensory inputs to patients that simulate an alternate environment. VR relaxation modules have shown promise in reducing acute pain scores and narcotic use in certain patients (such as pediatrics, patients undergoing uncomfortable procedures, or women in
⁎ Corresponding author at: The Foundation for Surgical Education and Innovation, The Oregon Clinic, 4805 NE Glisan street, Suite 6N60, Portland, OR 97213, United States. E-mail address: [email protected] (C.M. Dunst).
https://doi.org/10.1016/j.ctim.2020.102356 Received 9 October 2019; Received in revised form 28 January 2020; Accepted 24 February 2020 Available online 26 February 2020 0965-2299/ © 2020 Elsevier Ltd. All rights reserved.
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labor).6–11 While initial interventions using VR were meant to create an illusion of pain control by either inducing relaxation or simply distracting patients from their perception of pain, burgeoning literature suggests that the effects of virtual reality can extend beyond simple distraction and may in fact be effective in producing neurophysiologic changes related to conditioning and exposure therapies that could be effective in longer term pain control.12–16 As a large segment of surgical patients are undergoing elective operations with an expected period of at least a few days of some discomfort following their procedure, this suggested longer-term pain modulation provoked by the use of virtual reality could theoretically prove to be a valuable adjuvant tool in perioperative pain management and allow for decreasing narcotic utilization. However, the feasibility of using virtual reality longitudinally in the peri-operative setting has not been assessed and thus its use in the surgical field has remained quite limited. The practical challenges of incorporating such an intervention into the peri-operative workflow without disrupting nurses, anesthesiologists and the patient experience are unknown. The objective of this study is to assess the feasibility of implementing a virtual reality program into the perioperative care of patients undergoing foregut surgery. As a secondary goal, we aim to assess whether the incorporation of virtual reality into the peri-operative pain control strategy would create a reduction in pain scores and narcotic utilization, while improving the overall patient experience.
characteristics of gender, ethnicity, and BMI were collected on all patients through review of the electronic medical record. Patients were then randomized via computer software (Sealed Envelope Ltd. 2017) to the VR or the non-VR arm.17 Those patients enrolled in the virtual reality arm were provided with a wireless VR headset with a mindfulness/mediation application pre-installed (“Flow VR – Meditation for Modern Life” -Oculus Go platform, Fig. 1). The “Flow VR – Meditation for Modern Life” application consists of a series of 6 separate guided exercises (Breathe, Focus, Move, Let Go, Calm, and Restore) which teach aspects of mindfulness and meditation over approximately 4−5 min each. Patients were asked to complete the first three of the VR exercises in the pre-operative suite prior to proceeding to the operating room (approximately 13 min total). These same patients were given the VR device again on the morning of post-operative day #1 to complete the remaining three exercises at that time (approximately 15 min total). Administration of the VR intervention was managed by the research team. Operative details including the patients initial diagnosis, the type of operation performed, whether the operation was a revision or required a conversion to open, and the total hospital length of stay were collected on each patient. All patients in both arms of the study received standard post-operative scheduled pain control with Acetaminophen (1000 mg TID), Gabapentin (200 mg TID) and Toradol (15 mg q6h x 48 h) unless they had a contraindication to receiving one of these medications. Intravenous (IV) and oral narcotics were provided on an as needed basis at the discretion of the prescribing provider. All patients in both arms of the study completed simple pain questionnaires designed specifically for this study on the first morning following their operation (see Table 3 for a comprehensive list of questions included in the ‘postoperative pain’ data collection form). Those patients in the VR arm of the trial additionally completed a survey on their experience and impression of the VR device and program (see Table 4 for a comprehensive list of questions included in the ‘virtual reality experience’ data collection form). In addition, all patients completed a validated general satisfaction survey (PSQ-18)18 at the time of their discharge from the hospital. Participants were then contacted for a phone follow up at 2 weeks to determine how much pain medication they had utilized following their discharge by asking how many pills they had used and whether they had required a refill after discharge. Descriptive statistics were used to summarize demographic characteristics. Total narcotic pain medication utilization was converted to standard milligram morphine equivalents (MME) and tallied for each day of the hospitalization as well as after discharge.19 Patient satisfaction data was adjusted according to the standard scoring
2. Methods After local Institutional Review Board (IRB) approval, we approached all patients undergoing minimally invasive foregut surgery at our institution in a 6-month period between February and July of 2019. We included any patient whose expected post-operative stay was anticipated to be between 24−72 h, and who had the ability to use the virtual reality device. This included primarily patients undergoing first time or re-do fundoplication surgery, paraesophageal hernia repair, esophageal myotomy, or pyloroplasty as well as other minor surgeries requiring an overnight stay in the hospital. Outpatient surgeries were not included nor were those undergoing larger operations with more prolonged anticipated recovery periods. Those patients who agreed to participate in the study completed full written informed consent to participate and filled out an initial baseline pain survey assessing their current pain levels, any chronic use of pain medication or illicit substances, as well as how much pain they are expecting to have in the post-operative period (see Table 1 for full list of variables collected by our ‘pre-operative’ data collection form). Initial demographic Table 1 Demographics.
Total Patients Age (Years - Median) BMI (median) Female Gender History of Psychiatric Disorder* Substance Use Smoking History Regular Alcohol Use Regular Marijuana Use Medication History Chronic Opiate Use Chronic Benzodiazepine Use Antidepressant Prescriptions Pre-op Pain (mean) Baseline (0–10) Expected post-op pain score (0–10)
Total
VR Group
Non-VR Group
P-value
52 64.5 30.3 38 (73.1 %) 19 (36.5 %)
26 65.5 29.6 21 (81 %) 8 (30.8 %)
26 61.5 32.1 17 (65 %) 11 (42.3 %)
0.62 0.12 0.22 0.40
26 (50.0 %) 12 (23.1 %) 9 (17.3 %)
12 (46 %) 6 (23 %) 6 (23 %)
14 (54 %) 6 (23 %) 3 (12 %)
0.79 0.31 0.94
8 (12.4 %) 4 (7.7 %) 11 (21.2 %)
3 (11.5 %) 2 (7.7 %) 5 (19.2 %)
5 (19.2 %) 2 (7.7 %) 6 (23.0 %)
0.42 0.61 0.69
1.4 4.9
1.7 4.4
1.2 5.5
0.36 0.07
VR = virtual reality. *Includes anxiety, depression, bipolar disorder or panic disorders. **Regular use defined as at least monthly or more frequently. 2
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Fig. 1. Oculus Go Device.
instructions and a general satisfaction score was created for each patient.20 Students T-tests were used to compare means between groups.
Table 3 Patient Experience. Total
VR Group
Non-VR Group
p-value
3.9 6.3
3.8 6.1
3.9 6.6
0.88 0.49
4.2
3.8
4.7
0.30
2.4 2 4
2.3 2.4 3.9 (2.7–5.0)
2.5 1.5 4.2 (2.7–4.9)
0.79 0.18 0.10
3. Results Post-op Day #1 (means) Current Pain score (0–10) Worse Pain in first 24 hours (0–10) Time Spent Thinking about Pain (0=never, 10=constantly) Anxiety Score (0–10 - mean)* Nausea Score (0–10 - mean)* Mean Overall Satisfaction Score (range)**
A total of 61 patients were approached to participate in the study over the course of the enrollment period. Nine patients refused to participate, generally because they simply “didn’t want to” or were “just not interested”, although a single patient did site concerns that virtual reality had created significant nausea for her in the past. The remaining 52 patients agreed to participate in the study and underwent randomization resulting in 26 patients in the virtual reality (VR) arm and 26 in the non-virtual reality (non-VR) arm of the study. The population overall consisted of 73.1 % women with a median age of 64.5 years (ranging from 29 to 82). There were moderate rates of psychiatric disorders, substance use and chronic pain or anxiety, which were evenly distributed between the two groups (Table 1). Most of the enrolled patients underwent laparoscopic foregut surgery with the primary indication for surgery being reflux disease (38.5 %) followed by paraesophageal hernia (30.8 %). Other diagnoses including gastroparesis (11.5 %), gastric masses (11.5 %), achalasia (5.8 %) or esophageal diverticulum (5.8 %) completed the cohort. There was a statistically increased proportion of paraesophageal hernia patients and resulting paraesophageal hernia repairs in the VR group compared to the non-VR group, the latter of which contained more straightforward anti-reflux operations (Table 2). All but two surgeries were completed laparoscopically (96.2 %) and while both open procedures were in the VR arm, this did not reach statistical significance. A minority of cases in both groups were re-do operations (13.5 %) and length
*Anxiety and nausea scores were based on asking patient to what extent they have experienced pain/nausea in the last 24 h on a scale of 0(never) to 10 (all of the time). **Overall satisfaction calculated based on the weighted PSQ-18 results with a higher score equating to increased satisfaction.
of stay was not significantly different between groups. There were no other statistical differences between the groups. Total direct costs for completion of the study were $505.98 including the purchase of the two Oculus VR headsets ($249.00 each) and installation of the Flow VR meditation applications on each headset ($3.99 each). This equates to $9.70 per patient enrolled, though as the devices may be used in many more patients going forward, the actual cost per patient may be significantly lower. Indirect costs associated with the implementation of our VR program were not directly assessed in this study as VR training, implementation, data collection, and
Table 2 Surgical Variables*.
Total Patients Indication for Surgery Reflux Paraesophageal Hernia Gastroparesis Gastric Mass (polyps, dysplasia, or GIST) Achalasia Esophageal Diverticulum Type of Surgery Fundoplication alone Paraesophageal Hernia repair + Fundoplication Partial Gastrectomy (wedge or antrectomy) Pyloroplasty Myotomy and Fundoplication Other Conversion to Open Re-do Operation Median Length of Stay (days)
Total
VR Group
Non-VR Group
52
26
26
20 (38.5 %) 16 (30.8 %) 6 (11.5 %) 6 (11.5 %) 3 (5.8 %) 3 (5.8 %)
7 (26.9 %) 12 (46.1 %) 3 (11.5 %) 3 (11.5 %) 1 (3.8 %) 2 (7.7 %)
13 (50.0 %) 4 (15.4 %) 3 (11.5 %) 3 (11.5 %) 2 (7.7 %) 1 (3.8 %)
11 (21.2 %) 15 (28.8 %) 8 (15.4 %) 6 (11.5 %) 5 (9.6 %) 2 (3.8 %) 1 (1.9 %) 7 (13.5 %) 2.0
6 (23.0 %) 12 (46.1 %) 3 (11.5 %) 3 (11.5 %) 3 (11.5 %) 1 (3.8 %) 1 (3.8 %) 4 (15.4 %) 2.0
13 (50.0 %) 3 (11.5 %) 5 (19.2 %) 3 (11.5 %) 2 (7.7 %) 1 (3.8 %) 0 (0.0 %) 3 (11.5 %) 1.5
P-value
0.02*
0.04*
*Some patients had more than one diagnosis and more than one procedure during their operation, each of which is counted separately. 3
0.31 0.65 0.93
Complementary Therapies in Medicine 49 (2020) 102356
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Table 4 Virtual Reality Experience.
Table 5 Narcotic Utilization. Median (range)
Total Respondents Number who completed ALL six sessions Number of sessions completed (average) Previously used virtual reality Virtual reality Experience Time spent thinking about pain while using virtual reality (0 = none, 10=all the time) Worst pain during virtual reality (0 = none, 10=excruciating) How UNPLESANT was virtual reality (0 = not at all, 10=extremely unpleasant) How much ANXIETY did you have while using virtual reality (0 = none, 10=extreme) How much NAUSEA did you have while using virtual reality (0 = none, 10=vomiting) Virtual reality Opinions To what extent did you feel like you went inside the virtual environment (0 = not at all, 10=completely) Did Virtual Reality make you feel ABSENT from your pain experience (0 = not at all, 10=completely) Did you ENJOY using virtual reality (0 = not at all, 10=completely) Would you use virtual reality again? (0=definitely not, 10=definitely yes) Would you be interested in virtual reality designed specifically for post-operative pain (0 = not at all, 10=definitely)
23 (88.5 %) 17 (73.9 %) 4.8 1 (4.3 %)
Mean MME in 1 st 24 h post op Mean MME/Day while admitted Total MME taken after discharge None 1-100 101-200 201-300 > 300 Unknown Need For refills
2 (0–10) 3 (0–9) 2 (0–8) 0 (0–8) 0 (0–8)
Total
VR Group
Non-VR Group
P-value
74.6 (0–210) 65.5 (0–250)
96.8 (0–208.8) 70.3 (0–250)
52.32 (0–210) 60.91 (0–165)
0.10 0.57 0.91
9 (17.3 %) 13 (25.0 %) 8 (15.4 %) 8 (15.4 %) 9 (17.3 %) 5 (9.6 %) 12 (23.1 %)
5 5 6 3 5 2 5
(19.2 %) (19.2 %) (23 %) (11.5 %) (19.2 %) (7.7 %) (19.2 %)
4 8 2 5 4 3 7
(15.4 %) (30.8 %) (7.7 %) (19.2 %) (15.4 %) (11.5 %) (26.9 %)
0.52
*MME = Morphine Milligram Equivalents. 4 (0–8)
use VR again in the future (76.2 %) and would be interested in a virtual reality program designed specifically for pain control (62.0 %). Complete VR experience data is listed in Table 4 along with select positive and negative patient quotes. Over the study period, the nursing staff became comfortable incorporating VR into their work flow. Mean pain scores on post-operative day #1 were not significantly different between the VR and non-VR groups at 3.8 and 3.9 respectively, and more detailed pain, anxiety and nausea scales were also similar between the two groups (Table 3). The overall satisfaction scores based on the graded PSQ-18 results showed similar overall satisfaction between VR and non-VR patients. Narcotic utilization tracked in terms of milligrams of morphine equivalents (MME) in fact showed a trend towards increased narcotic utilization in the first 24 h post-operatively in the patients in the VR arm, though this difference did not reach statistical significance and seemed to balance out over the course of the entirety of the hospitalization. Similarly, the two groups had comparable rates of post-op prescription utilization and need for refills (Table 5, Fig. 2). However, while also not statistically significant, we do find lower absolute pain and anxiety scores and fewer narcotic prescription refills for the VR group, despite the fact that the VR group received significantly more complex operations by chance. Follow up for the study was excellent with the vast majority of our patients completing all questionnaires with only 2 missing in-hospital pain questionnaires and 2 missing satisfaction surveys. Three patients were unable to be contacted for their 2 week follow up call despite multiple attempts and a single patient died from complications of an unrelated second surgery prior to her two week phone call and thus was also lost to follow up.
4 (0–10) 7 (1–10) 6 (1–10)* 7 (0–10)**
Positive Patient Comments: "I think having alternative care, i.e. pain management is excellent." "The anxiety went away." "VR decreased worst pain." "Thank you for developing programs such as this, with the goal of assisting the patient. I have lived with debilitating back pain since 1999 and appreciate the strides that are being made with pain management techniques. I’m grateful for being given this opportunity to participate in the VR study. " Negative Patient Comments: "First one or two sessions - more difficult to concentrate because staff talking in background. Much more relaxing when alone." "I understand the concept of throwing away unpleasant feeling but did not like this one much because of being on a cliff. I do not like heights - I have vertigo." "I found the helmet very hard to wear and tilt so I could see what I was looking at. I found the segment where it asked you to move around pretty ambitious day after surgery." “I was given the VR device pre-OP and no one of the nurses knew what it was, and three people were talking to me at one time so I really didn’t get much time to try it. The equipment wasn’t adjusted so it was uncomfortably tight and infringed on my breathing, hurt my face so was relieved when it was over.”
* 16/21 patients (76.2 %) responded with a score > 5 indicating that they would use VR again. ** 13/21 patients (62.0 %) responded with a score > 5 indicated that they would be interested in pain focused virtual reality.
4. Discussion
follow-up were performed directly by the authors at no additional cost to our institution. Of individuals in the virtual reality arm, 23 of 26 (88.5 %) completed the virtual reality experience survey. Seventeen (73.9 %) of the patients were able to complete all 6 VR exercises, while 9 failed to do so, typically related to not enjoying the device and choosing to terminate their participation, or due to difficulty using the device itself. No patient missed VR exercises due to staffing issues. Only 1 of the patients in the VR arm had tried VR before with the rest (96.1 %) being new to the technology. On average, these patients spent very little time thinking about their pain or anxiety while participating in the VR exercise, and did not feel that the VR was unpleasant to use. There were no major complications related to the use of the device, though one patient decided to withdraw from the study during the first minute of VR treatment as they were uncomfortable with the device. In all, the majority of patients who used the VR device responded that they would
In this work, we have shown that virtual reality is a safe adjuvant tool in the multimodal approach to managing patients with pain and anxiety in the peri-operative period. These results show encouraging preliminary evidence of the feasibility and patient acceptability of using VR mindfulness to help improve the experience of patients undergoing a stressful surgery. Although the analgesic benefits of VR mindfulness exercises as they were implemented in this study were not statistically significant, many of the pain and narcotic variables did trend in an improved direction (lower absolute pain and anxiety scores and fewer narcotic prescription refills for the VR group, despite the fact that the VR group received significantly more complex operations by chance). This gives credence to the possible beneficial effect of VR in the management of surgical patients, though the data here could not capture the effect statistically. Many other authors have demonstrated statistically the objective 4
Complementary Therapies in Medicine 49 (2020) 102356
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Fig. 2. Post-Discharge pain medication utilization.
It is disappointing to see no difference in the narcotic utilization between the VR and non-VR groups in our study despite the fact that multiple previous authors have clearly demonstrated a benefit to the use of virtual reality in pain control.4–16 Unfortunately, as it turned out, despite random assignment to groups, our VR group purely by chance had a statistically significantly higher proportion of large paraesophageal hernia repairs, a more complex surgery, compared to the non-VR group, which tended to have more straightforward anti-reflux operations. This difference may account for the trend towards increased narcotic utilization seen in the VR group, specifically in the first 24 h after their larger, more painful, operations. Encouragingly though, despite their larger surgeries, the VR meditation group did show the predicted pattern of lower absolute pain and anxiety scores and fewer refills of their opioid prescriptions post discharge, (19.2 % for the VR group versus 26.9 % for the Non-VR group). It is important to note, however, that none of these findings were statistically significant, and we cannot draw definitive conclusions on this topic from the current data. However, the lack of statistical difference between groups when one group had larger and more complex surgeries may suggest some benefit to the VR that we were not able to capture with the current study design. A further point of interest is the question of distraction versus neuromodulation and how each plays a role in the application of VR in the perioperative setting. The majority of the current literature uses virtual reality as a distraction from pain, suggesting that using the device while feeling severe pain can reduce the nociceptive activation.10,11 This is challenging in the perioperative setting. Although postoperative pain is still considered ‘acute’ pain, the nociceptive experience is more likely to be longitudinal, over the course of at least a few days. As it is not reasonable to use a VR device constantly for several days, the best implementation of VR in the perioperative setting is uncertain. However, there are a few studies that suggest that virtual reality could be used to manage chronic pain via neuromodulation techniques rather than simply by distraction.9,13,15,16 As surgical pain falls somewhere between acute procedural and long-term chronic pain, it is hard to know when and how to apply VR to fall somewhere between these two strategies. The VR method used in this study was administered in set sessions almost as ‘doses’ rather than allowing patients to use the headsets on an as needed basis. This was done in an attempt to standardize the VR utilization but may have actually limited the benefit of the device, which might have had increased efficacy if patients were allowed to use it whenever they were experiencing acute pain or anxiety, rather than only at set times in their post-operative course. This study certainly has several limitations including the relatively small sample size and the wide variety of different surgical procedures included in the patient population, which would certainly be expected to have differing levels of perioperative pain. Our choice of a passive
benefits of virtual reality in other areas of medicine such as during labor, procedures or chemotherapy. “In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology”.6 Multiple studies in various fields of medicine have been able to demonstrate that the use of virtual reality can improve the experience of pain,7,9,10,14 reduce anxiety7,8 and reduce narcotic utilization in the acute setting.21 However, previous research that has dealt with the application of virtual reality to live clinical situations has struggled with multiple challenges including theoretical immaturity, a lack of technical standards, the problems of separating effects of media versus medium, practical in vivo issues, and cost, all of which have made the feasibility of large scale VR use somewhat questionable and were certainly encountered here.22 In this study, patients who participated in the VR program were usually able to complete all of the exercise, enjoyed using the device, had low pain, nausea and anxiety scores while using it, and experienced no major complications. The majority of patients who used the VR device responded that they would use VR again in the future (76.2 %) and would be interested in a virtual reality program designed specifically for pain control (62.0 %). There was very little cost to implement the virtual reality program and it was easily worked into standard work flows. Overall, VR is well received by patients and can be successfully implemented in a perioperative setting. While they make up the minority, it is interesting to consider the patients who did not accommodate well to the use of the VR device and did not enjoy it. Anecdotally, these patients frequently fell into one of two groups, either digital naïve or digital native.23 The digital naïve patients are those patients who do not regularly use technology, often the elderly individuals that make up a large portion of our patient population, and as a result are uncomfortable with the device. These patients tended to become easily confused or flustered during its use, leading to their dislike of it and in a few cases, their unwillingness to continue. The far opposite extreme that we noted was in the digital natives, young individuals who have grown up with advanced technology as second nature and who often found the very simple and straightforward meditation program that we chose (specifically so that all patients, including the digital naïve ones would be able to do it) too rudimentary to hold their attention. The population that specifically did not enjoy VR in this study also seemed to have undergone a higher proportion of more complex surgeries (almost exclusively large paraesophageal hernia repairs) and had a median age 10 years older than those who enjoyed using the VR device (71 versus 61 years). This does beg the question of which population is truly ideal for the application of a virtual reality program. Perhaps digital immigrants (those who have embraced new technologies but not been overwhelmed by them) will find such a device most useful, though better defining the target patient population will require additional investigation. 5
Complementary Therapies in Medicine 49 (2020) 102356
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Kevin M. Reavis: Conceptualization, Investigation, Writing - review & editing, Supervision. Daniel D. Bradley: Conceptualization, Investigation, Writing - review & editing, Supervision. Christy M. Dunst: Conceptualization, Methodology, Validation, Investigation, Resources, Writing - review & editing, Supervision, Funding acquisition.
meditation exercise may have also affected the outcomes as studies have shown that interactive virtual reality programs are more effective at reducing pain than simple passive experiences.12 It is also difficult to know with our chosen VR experience whether it is the VR itself or rather the meditation exercises that are primarily responsible for the results, as it is difficult to differentiate the effect of the media versus of the medium. This study is further limited by the population having consisted mostly of elderly women (digital naive), which makes generalizability a bit questionable. The Hawthorne effect may come into play as well with patients in this study as they are being asked so frequently about pain and anxiety with our frequent questionnaires that it may alter their perceptions and actions around their perioperative pain. To improve the effectiveness of VR integration in the future, there are certainly areas for potential improvement. Specific time in the preoperative setting should be protected so as to not interrupt nursing workflow. We found that education and buy in from all care team members helps significantly with the patient’s overall experience with VR. We feel that giving better instructions for use, and improving the integration of the VR device into the pre and post-operative workflow in non-disruptive ways could have improved our patient experience scores. In fact, the lack of improvement in satisfaction scores may be related to our very early experience in implementation, which resulted in some confusion and conflict around use of the device and likely negatively impacted the patient’s experience. Ultimately, while we have shown feasibility of implementing a VR program into perioperative care, additional larger studies will be required to determine if there are specific patient populations that will benefit most (such as digital immigrants or patients with anxiety or depression), different VR programs that might be more effective (those specifically designed for pain modulation, or those that are more interactive), or better ways in which to implement VR into standard workflows. Even given our overall equivocal results, it was promising to see that there were a few patients in particular who benefited dramatically from the use of the VR device, including a patient with chronic previous opiate addiction. This patient was very nervous about pain control and needing narcotics during his hospitalization and was hoping to avoid them as previous surgeries had caused him to lapse into abuse. Using the VR device, the patient was able to avoid the use of narcotics completely during his hospitalization and credits the device for his success.
Declaration of Competing Interest No author has any conflict of interest to disclose. Acknowledgements We would like to acknowledge the significant contributions of our office staff including Sarah Martinez who made numerous follow-up phone calls and was instrumental to our data collection as well as Angi Gill, our IRB coordinator, without whom this project would not have been possible. Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at doi:https://doi.org/10.1016/j.ctim.2020.102356. References 1. Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic opioid dependence in the United States: Are surgeons the gatekeepers? Ann Surg. 2017;265(4):728–730. 2. Stoicea N, Costa A, Periel L, Uribe A, Weaver T, Bergese SD. Current perspectives on the opioid crisis in the US healthcare system: A comprehensive literature review. Medicine (Baltimore). 2019;98(20):e15425. 3. Webster LR, Brennan MJ, Kwong LM, Levandowski R, Gudin JA. Opioid abuse-deterrent strategies: Role of clinicians in acute pain management. Postgrad Med. 2016;128(1):76–84. 4. Honzel E, Murthi S, Brawn-Cinani B, et al. Virtual Reality, Music and Pain: Developing the premise for an interdisciplinary approach to pain management. Pain. 2019. 5. Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual reality as a clinical tool for pain management. Curr Pain Headache Rep. 2018;22(8):53. 6. Li L, Yu F, Shi D, et al. Application of virtual reality technology in clinical medicine. Am J Transl Res. 2017;9(9):3867–3880. 7. Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual reality-assisted pain, anxiety, and anger management in the emergency department. Telemed J E Health. 2019. https://doi.org/10.1089/tmj.2018.0273 [Epub ahead of print]. 8. Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017;63(12):932–934. 9. Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: A systematic review and meta-analysis. J Pain Res. 2019;12:2053–2085. 10. Maani CV, Hoffman HG, Fowler M, Maiers AJ, Gaylord KM, Desocio PA. Combining ketamine and virtual reality pain control during severe burn wound care: One military and one civilian patient. Pain Med. 2011;12(4):673–678. 11. Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual reality as a distraction intervention to relieve pain and distress during medical procedures: A comprehensive literature review. Clin J Pain. 2018;34(9):858–877. 12. Loreto-Quijada D, Gutiérrez-Maldonado J, Nieto R, et al. Differential effects of two virtual reality interventions: Distraction versus pain control. Cyberpsychol Behav Soc Netw. 2014;17(6):353–358. 13. Gupta A, Scott K, Dukewich M. Innovative technology using virtual reality in the treatment of pain: Does it reduce pain via distraction, or is there more to it? Pain Med. 2018;19(1):151–159. 14. Tashjian VC, Mosadeghi S, Howard AR, et al. Virtual reality for management of pain in hospitalized patients: Results of a controlled trial. JMIR Ment Health. 2017;4(1):e9. 15. Jones T, Moore T, Choo J. The impact of virtual reality on chronic pain. PLoS One. 2016;11(12):e0167523. 16. Garrett B, Taverner T, McDade P. Virtual reality as an adjunct home therapy in chronic pain management: An exploratory study. JMIR Med Inform. 2017;5(2):e11. 17. Sealed Envelope Ltd: Create a blocked randomization list. 2017. Accessed 8 Feb 2019. Available online: https://www.sealedenvelope.com/simple-randomiser/v1/ lists. 18. Thayaparan AJ, Mahdi E. The Patient Satisfaction Questionnaire Short Form (PSQ18) as an adaptable, reliable, and validated tool for use in various settings. Med Educ Online. 2013;18:21747. 19. Opiate Equianalgesic Dosing Chart. UNC Healthcare Guideline. University of North Carolina Hospitals Pharmacy & Therapeutics Committee. Accessed 28 July 2019. Available online: https://www.med.unc.edu/aging/files/2018/06/AnalgesicEquivalent-Chart.pdf. 20. Instructions for Scoring the PSQ-18. Accessed 28 July 2019. Available online:
5. Conclusion Virtual reality is a safe and simple intervention that is associated with high rates of patient satisfaction. While narcotic utilization was not statistically decreased in the current study, our overall experience suggests that this device holds promise as an adjuvant tool in the multimodal approach to pain and anxiety in the perioperative period and could make a meaningful impact for appropriately selected patients. Source of funding Portland IPA research grant. CRediT authorship contribution statement Kelly R. Haisley: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Resources, Data curation, Writing original draft, Writing - review & editing, Visualization, Project administration. Olivia J. Straw: Formal analysis, Data curation, Writing original draft, Visualization. Dolores T. Müller: Methodology, Validation, Formal analysis, Data curation, Writing - review & editing, Project administration. Michael A. Antiporda: Conceptualization, Methodology, Investigation, Writing - review & editing. Ahmed M. Zihni: Conceptualization, Investigation, Writing - review & editing. 6
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22. Garrett B, Taverner T, Gromala D, Tao G, Cordingley E, Sun C. Virtual reality clinical research: Promises and challenges. JMIR Serious Games. 2018;6(4):e10839. 23. Haluza D, Naszay M, Stockinger A, Jungwirth D. Digital natives versus digital immigrants: Influence of online health information seeking on the doctor-patient relationship. Health Commun. 2017;32(11):1342–1349.
https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/ psq/psq18_scoring.pdf. 21. McSherry T, Atterbury M, Gartner S, Helmold E, Searles DM, Schulman C. Randomized, crossover study of immersive virtual reality to decrease opioid use during painful wound care procedures in adults. J Burn Care Res. 2018;39(2):278–285.
7
Contents lists available at ScienceDirect
Complementary Therapies in Medicine journal homepage: www.elsevier.com/locate/ctim
Feasibility of implementing a virtual reality program as an adjuvant tool for peri-operative pain control; Results of a randomized controlled trial in minimally invasive foregut surgery
T
Kelly R. Haisleya,b,c, Olivia J. Strawb, Dolores T. Müllerb, Michael A. Antipordab,d, Ahmed M. Zihnib,e, Kevin M. Reavisb,c, Daniel D. Bradleyb,c, Christy M. Dunstb,c,* a
Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, United States Foundation for Surgical Innovation and Education, Portland, OR, United States Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States d GI Surgical Specialists, Fort Meyers, FL, United States e Denver Esopahgeal and Stomach Center, Denver, CO, United States b c
A R T I C LE I N FO
A B S T R A C T
Keywords: Virtual reality Multimodal pain control Peri-operative management Narcotic utilization
Background: Post-operative pain control and narcotic over-utilization are challenging issues for surgeons in all fields. While virtual reality (VR) has been increasingly applied in various fields, its feasibility and efficacy in the peri-operative period has not been evaluated. The aim of this study was to examine the experience of an integrated VR protocol in the perioperative setting. Methods: Patients undergoing minimally invasive foregut surgery at a single institution were randomized to receive a series of VR meditation/mindfulness sessions (VR) or to standard care after surgery (non-VR). Postoperative pain levels, narcotic utilization and patient satisfaction were tracked. Results: Fifty-two patients were enrolled with 26 in each arm. Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups. For patients in the VR arm, sessions were able to be incorporated into the perioperative routine with little disruption. Most (73.9 %) were able complete all six VR sessions and reported low pain, anxiety, and nausea scores while using the device. A high proportion responded that they would use VR again (76.2 %) or would like a VR program designed for pain (62.0 %). There were no complications from device usage. Conclusion: VR is a safe and simple intervention that is associated with high patient satisfaction and is feasible to implement in the perioperative setting. While the current study is underpowered to detect difference in narcotic utilization, this device holds promise as an adjuvant tool in multimodal pain and anxiety control in the perioperative period.
1. Introduction Post-operative pain and other stressful stimuli remain major hurdles to recovery in all fields of surgery. While opioids have been the mainstay of perioperative pain control for decades, these drugs can expose patients to a risk of dependence and do little to address the fear and anxiety that may also contribute to coping in this stressful period. As the opiate crisis has grown, there has been increasing recognition of the dangers of narcotic overuse and the role that legal narcotic prescribing, frequently by surgeons, has played as the gateway to abuse and addiction.1,2 As a result, there has been considerable work in recent years
to try to identify novel and multimodal approaches to pain and anxiety control to decrease our current dependence on opiates and help to overcome some of the obstacles to a smooth and safe recovery after surgery.3 Virtual reality (VR) has been proposed as an adjuvant patient care tool to try to address pain as well as overall psychosocial stress dynamics that accompany the experience of pain.4,5 VR involves using electronic devices to provide sensory inputs to patients that simulate an alternate environment. VR relaxation modules have shown promise in reducing acute pain scores and narcotic use in certain patients (such as pediatrics, patients undergoing uncomfortable procedures, or women in
⁎ Corresponding author at: The Foundation for Surgical Education and Innovation, The Oregon Clinic, 4805 NE Glisan street, Suite 6N60, Portland, OR 97213, United States. E-mail address: [email protected] (C.M. Dunst).
https://doi.org/10.1016/j.ctim.2020.102356 Received 9 October 2019; Received in revised form 28 January 2020; Accepted 24 February 2020 Available online 26 February 2020 0965-2299/ © 2020 Elsevier Ltd. All rights reserved.
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labor).6–11 While initial interventions using VR were meant to create an illusion of pain control by either inducing relaxation or simply distracting patients from their perception of pain, burgeoning literature suggests that the effects of virtual reality can extend beyond simple distraction and may in fact be effective in producing neurophysiologic changes related to conditioning and exposure therapies that could be effective in longer term pain control.12–16 As a large segment of surgical patients are undergoing elective operations with an expected period of at least a few days of some discomfort following their procedure, this suggested longer-term pain modulation provoked by the use of virtual reality could theoretically prove to be a valuable adjuvant tool in perioperative pain management and allow for decreasing narcotic utilization. However, the feasibility of using virtual reality longitudinally in the peri-operative setting has not been assessed and thus its use in the surgical field has remained quite limited. The practical challenges of incorporating such an intervention into the peri-operative workflow without disrupting nurses, anesthesiologists and the patient experience are unknown. The objective of this study is to assess the feasibility of implementing a virtual reality program into the perioperative care of patients undergoing foregut surgery. As a secondary goal, we aim to assess whether the incorporation of virtual reality into the peri-operative pain control strategy would create a reduction in pain scores and narcotic utilization, while improving the overall patient experience.
characteristics of gender, ethnicity, and BMI were collected on all patients through review of the electronic medical record. Patients were then randomized via computer software (Sealed Envelope Ltd. 2017) to the VR or the non-VR arm.17 Those patients enrolled in the virtual reality arm were provided with a wireless VR headset with a mindfulness/mediation application pre-installed (“Flow VR – Meditation for Modern Life” -Oculus Go platform, Fig. 1). The “Flow VR – Meditation for Modern Life” application consists of a series of 6 separate guided exercises (Breathe, Focus, Move, Let Go, Calm, and Restore) which teach aspects of mindfulness and meditation over approximately 4−5 min each. Patients were asked to complete the first three of the VR exercises in the pre-operative suite prior to proceeding to the operating room (approximately 13 min total). These same patients were given the VR device again on the morning of post-operative day #1 to complete the remaining three exercises at that time (approximately 15 min total). Administration of the VR intervention was managed by the research team. Operative details including the patients initial diagnosis, the type of operation performed, whether the operation was a revision or required a conversion to open, and the total hospital length of stay were collected on each patient. All patients in both arms of the study received standard post-operative scheduled pain control with Acetaminophen (1000 mg TID), Gabapentin (200 mg TID) and Toradol (15 mg q6h x 48 h) unless they had a contraindication to receiving one of these medications. Intravenous (IV) and oral narcotics were provided on an as needed basis at the discretion of the prescribing provider. All patients in both arms of the study completed simple pain questionnaires designed specifically for this study on the first morning following their operation (see Table 3 for a comprehensive list of questions included in the ‘postoperative pain’ data collection form). Those patients in the VR arm of the trial additionally completed a survey on their experience and impression of the VR device and program (see Table 4 for a comprehensive list of questions included in the ‘virtual reality experience’ data collection form). In addition, all patients completed a validated general satisfaction survey (PSQ-18)18 at the time of their discharge from the hospital. Participants were then contacted for a phone follow up at 2 weeks to determine how much pain medication they had utilized following their discharge by asking how many pills they had used and whether they had required a refill after discharge. Descriptive statistics were used to summarize demographic characteristics. Total narcotic pain medication utilization was converted to standard milligram morphine equivalents (MME) and tallied for each day of the hospitalization as well as after discharge.19 Patient satisfaction data was adjusted according to the standard scoring
2. Methods After local Institutional Review Board (IRB) approval, we approached all patients undergoing minimally invasive foregut surgery at our institution in a 6-month period between February and July of 2019. We included any patient whose expected post-operative stay was anticipated to be between 24−72 h, and who had the ability to use the virtual reality device. This included primarily patients undergoing first time or re-do fundoplication surgery, paraesophageal hernia repair, esophageal myotomy, or pyloroplasty as well as other minor surgeries requiring an overnight stay in the hospital. Outpatient surgeries were not included nor were those undergoing larger operations with more prolonged anticipated recovery periods. Those patients who agreed to participate in the study completed full written informed consent to participate and filled out an initial baseline pain survey assessing their current pain levels, any chronic use of pain medication or illicit substances, as well as how much pain they are expecting to have in the post-operative period (see Table 1 for full list of variables collected by our ‘pre-operative’ data collection form). Initial demographic Table 1 Demographics.
Total Patients Age (Years - Median) BMI (median) Female Gender History of Psychiatric Disorder* Substance Use Smoking History Regular Alcohol Use Regular Marijuana Use Medication History Chronic Opiate Use Chronic Benzodiazepine Use Antidepressant Prescriptions Pre-op Pain (mean) Baseline (0–10) Expected post-op pain score (0–10)
Total
VR Group
Non-VR Group
P-value
52 64.5 30.3 38 (73.1 %) 19 (36.5 %)
26 65.5 29.6 21 (81 %) 8 (30.8 %)
26 61.5 32.1 17 (65 %) 11 (42.3 %)
0.62 0.12 0.22 0.40
26 (50.0 %) 12 (23.1 %) 9 (17.3 %)
12 (46 %) 6 (23 %) 6 (23 %)
14 (54 %) 6 (23 %) 3 (12 %)
0.79 0.31 0.94
8 (12.4 %) 4 (7.7 %) 11 (21.2 %)
3 (11.5 %) 2 (7.7 %) 5 (19.2 %)
5 (19.2 %) 2 (7.7 %) 6 (23.0 %)
0.42 0.61 0.69
1.4 4.9
1.7 4.4
1.2 5.5
0.36 0.07
VR = virtual reality. *Includes anxiety, depression, bipolar disorder or panic disorders. **Regular use defined as at least monthly or more frequently. 2
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Fig. 1. Oculus Go Device.
instructions and a general satisfaction score was created for each patient.20 Students T-tests were used to compare means between groups.
Table 3 Patient Experience. Total
VR Group
Non-VR Group
p-value
3.9 6.3
3.8 6.1
3.9 6.6
0.88 0.49
4.2
3.8
4.7
0.30
2.4 2 4
2.3 2.4 3.9 (2.7–5.0)
2.5 1.5 4.2 (2.7–4.9)
0.79 0.18 0.10
3. Results Post-op Day #1 (means) Current Pain score (0–10) Worse Pain in first 24 hours (0–10) Time Spent Thinking about Pain (0=never, 10=constantly) Anxiety Score (0–10 - mean)* Nausea Score (0–10 - mean)* Mean Overall Satisfaction Score (range)**
A total of 61 patients were approached to participate in the study over the course of the enrollment period. Nine patients refused to participate, generally because they simply “didn’t want to” or were “just not interested”, although a single patient did site concerns that virtual reality had created significant nausea for her in the past. The remaining 52 patients agreed to participate in the study and underwent randomization resulting in 26 patients in the virtual reality (VR) arm and 26 in the non-virtual reality (non-VR) arm of the study. The population overall consisted of 73.1 % women with a median age of 64.5 years (ranging from 29 to 82). There were moderate rates of psychiatric disorders, substance use and chronic pain or anxiety, which were evenly distributed between the two groups (Table 1). Most of the enrolled patients underwent laparoscopic foregut surgery with the primary indication for surgery being reflux disease (38.5 %) followed by paraesophageal hernia (30.8 %). Other diagnoses including gastroparesis (11.5 %), gastric masses (11.5 %), achalasia (5.8 %) or esophageal diverticulum (5.8 %) completed the cohort. There was a statistically increased proportion of paraesophageal hernia patients and resulting paraesophageal hernia repairs in the VR group compared to the non-VR group, the latter of which contained more straightforward anti-reflux operations (Table 2). All but two surgeries were completed laparoscopically (96.2 %) and while both open procedures were in the VR arm, this did not reach statistical significance. A minority of cases in both groups were re-do operations (13.5 %) and length
*Anxiety and nausea scores were based on asking patient to what extent they have experienced pain/nausea in the last 24 h on a scale of 0(never) to 10 (all of the time). **Overall satisfaction calculated based on the weighted PSQ-18 results with a higher score equating to increased satisfaction.
of stay was not significantly different between groups. There were no other statistical differences between the groups. Total direct costs for completion of the study were $505.98 including the purchase of the two Oculus VR headsets ($249.00 each) and installation of the Flow VR meditation applications on each headset ($3.99 each). This equates to $9.70 per patient enrolled, though as the devices may be used in many more patients going forward, the actual cost per patient may be significantly lower. Indirect costs associated with the implementation of our VR program were not directly assessed in this study as VR training, implementation, data collection, and
Table 2 Surgical Variables*.
Total Patients Indication for Surgery Reflux Paraesophageal Hernia Gastroparesis Gastric Mass (polyps, dysplasia, or GIST) Achalasia Esophageal Diverticulum Type of Surgery Fundoplication alone Paraesophageal Hernia repair + Fundoplication Partial Gastrectomy (wedge or antrectomy) Pyloroplasty Myotomy and Fundoplication Other Conversion to Open Re-do Operation Median Length of Stay (days)
Total
VR Group
Non-VR Group
52
26
26
20 (38.5 %) 16 (30.8 %) 6 (11.5 %) 6 (11.5 %) 3 (5.8 %) 3 (5.8 %)
7 (26.9 %) 12 (46.1 %) 3 (11.5 %) 3 (11.5 %) 1 (3.8 %) 2 (7.7 %)
13 (50.0 %) 4 (15.4 %) 3 (11.5 %) 3 (11.5 %) 2 (7.7 %) 1 (3.8 %)
11 (21.2 %) 15 (28.8 %) 8 (15.4 %) 6 (11.5 %) 5 (9.6 %) 2 (3.8 %) 1 (1.9 %) 7 (13.5 %) 2.0
6 (23.0 %) 12 (46.1 %) 3 (11.5 %) 3 (11.5 %) 3 (11.5 %) 1 (3.8 %) 1 (3.8 %) 4 (15.4 %) 2.0
13 (50.0 %) 3 (11.5 %) 5 (19.2 %) 3 (11.5 %) 2 (7.7 %) 1 (3.8 %) 0 (0.0 %) 3 (11.5 %) 1.5
P-value
0.02*
0.04*
*Some patients had more than one diagnosis and more than one procedure during their operation, each of which is counted separately. 3
0.31 0.65 0.93
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Table 4 Virtual Reality Experience.
Table 5 Narcotic Utilization. Median (range)
Total Respondents Number who completed ALL six sessions Number of sessions completed (average) Previously used virtual reality Virtual reality Experience Time spent thinking about pain while using virtual reality (0 = none, 10=all the time) Worst pain during virtual reality (0 = none, 10=excruciating) How UNPLESANT was virtual reality (0 = not at all, 10=extremely unpleasant) How much ANXIETY did you have while using virtual reality (0 = none, 10=extreme) How much NAUSEA did you have while using virtual reality (0 = none, 10=vomiting) Virtual reality Opinions To what extent did you feel like you went inside the virtual environment (0 = not at all, 10=completely) Did Virtual Reality make you feel ABSENT from your pain experience (0 = not at all, 10=completely) Did you ENJOY using virtual reality (0 = not at all, 10=completely) Would you use virtual reality again? (0=definitely not, 10=definitely yes) Would you be interested in virtual reality designed specifically for post-operative pain (0 = not at all, 10=definitely)
23 (88.5 %) 17 (73.9 %) 4.8 1 (4.3 %)
Mean MME in 1 st 24 h post op Mean MME/Day while admitted Total MME taken after discharge None 1-100 101-200 201-300 > 300 Unknown Need For refills
2 (0–10) 3 (0–9) 2 (0–8) 0 (0–8) 0 (0–8)
Total
VR Group
Non-VR Group
P-value
74.6 (0–210) 65.5 (0–250)
96.8 (0–208.8) 70.3 (0–250)
52.32 (0–210) 60.91 (0–165)
0.10 0.57 0.91
9 (17.3 %) 13 (25.0 %) 8 (15.4 %) 8 (15.4 %) 9 (17.3 %) 5 (9.6 %) 12 (23.1 %)
5 5 6 3 5 2 5
(19.2 %) (19.2 %) (23 %) (11.5 %) (19.2 %) (7.7 %) (19.2 %)
4 8 2 5 4 3 7
(15.4 %) (30.8 %) (7.7 %) (19.2 %) (15.4 %) (11.5 %) (26.9 %)
0.52
*MME = Morphine Milligram Equivalents. 4 (0–8)
use VR again in the future (76.2 %) and would be interested in a virtual reality program designed specifically for pain control (62.0 %). Complete VR experience data is listed in Table 4 along with select positive and negative patient quotes. Over the study period, the nursing staff became comfortable incorporating VR into their work flow. Mean pain scores on post-operative day #1 were not significantly different between the VR and non-VR groups at 3.8 and 3.9 respectively, and more detailed pain, anxiety and nausea scales were also similar between the two groups (Table 3). The overall satisfaction scores based on the graded PSQ-18 results showed similar overall satisfaction between VR and non-VR patients. Narcotic utilization tracked in terms of milligrams of morphine equivalents (MME) in fact showed a trend towards increased narcotic utilization in the first 24 h post-operatively in the patients in the VR arm, though this difference did not reach statistical significance and seemed to balance out over the course of the entirety of the hospitalization. Similarly, the two groups had comparable rates of post-op prescription utilization and need for refills (Table 5, Fig. 2). However, while also not statistically significant, we do find lower absolute pain and anxiety scores and fewer narcotic prescription refills for the VR group, despite the fact that the VR group received significantly more complex operations by chance. Follow up for the study was excellent with the vast majority of our patients completing all questionnaires with only 2 missing in-hospital pain questionnaires and 2 missing satisfaction surveys. Three patients were unable to be contacted for their 2 week follow up call despite multiple attempts and a single patient died from complications of an unrelated second surgery prior to her two week phone call and thus was also lost to follow up.
4 (0–10) 7 (1–10) 6 (1–10)* 7 (0–10)**
Positive Patient Comments: "I think having alternative care, i.e. pain management is excellent." "The anxiety went away." "VR decreased worst pain." "Thank you for developing programs such as this, with the goal of assisting the patient. I have lived with debilitating back pain since 1999 and appreciate the strides that are being made with pain management techniques. I’m grateful for being given this opportunity to participate in the VR study. " Negative Patient Comments: "First one or two sessions - more difficult to concentrate because staff talking in background. Much more relaxing when alone." "I understand the concept of throwing away unpleasant feeling but did not like this one much because of being on a cliff. I do not like heights - I have vertigo." "I found the helmet very hard to wear and tilt so I could see what I was looking at. I found the segment where it asked you to move around pretty ambitious day after surgery." “I was given the VR device pre-OP and no one of the nurses knew what it was, and three people were talking to me at one time so I really didn’t get much time to try it. The equipment wasn’t adjusted so it was uncomfortably tight and infringed on my breathing, hurt my face so was relieved when it was over.”
* 16/21 patients (76.2 %) responded with a score > 5 indicating that they would use VR again. ** 13/21 patients (62.0 %) responded with a score > 5 indicated that they would be interested in pain focused virtual reality.
4. Discussion
follow-up were performed directly by the authors at no additional cost to our institution. Of individuals in the virtual reality arm, 23 of 26 (88.5 %) completed the virtual reality experience survey. Seventeen (73.9 %) of the patients were able to complete all 6 VR exercises, while 9 failed to do so, typically related to not enjoying the device and choosing to terminate their participation, or due to difficulty using the device itself. No patient missed VR exercises due to staffing issues. Only 1 of the patients in the VR arm had tried VR before with the rest (96.1 %) being new to the technology. On average, these patients spent very little time thinking about their pain or anxiety while participating in the VR exercise, and did not feel that the VR was unpleasant to use. There were no major complications related to the use of the device, though one patient decided to withdraw from the study during the first minute of VR treatment as they were uncomfortable with the device. In all, the majority of patients who used the VR device responded that they would
In this work, we have shown that virtual reality is a safe adjuvant tool in the multimodal approach to managing patients with pain and anxiety in the peri-operative period. These results show encouraging preliminary evidence of the feasibility and patient acceptability of using VR mindfulness to help improve the experience of patients undergoing a stressful surgery. Although the analgesic benefits of VR mindfulness exercises as they were implemented in this study were not statistically significant, many of the pain and narcotic variables did trend in an improved direction (lower absolute pain and anxiety scores and fewer narcotic prescription refills for the VR group, despite the fact that the VR group received significantly more complex operations by chance). This gives credence to the possible beneficial effect of VR in the management of surgical patients, though the data here could not capture the effect statistically. Many other authors have demonstrated statistically the objective 4
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Fig. 2. Post-Discharge pain medication utilization.
It is disappointing to see no difference in the narcotic utilization between the VR and non-VR groups in our study despite the fact that multiple previous authors have clearly demonstrated a benefit to the use of virtual reality in pain control.4–16 Unfortunately, as it turned out, despite random assignment to groups, our VR group purely by chance had a statistically significantly higher proportion of large paraesophageal hernia repairs, a more complex surgery, compared to the non-VR group, which tended to have more straightforward anti-reflux operations. This difference may account for the trend towards increased narcotic utilization seen in the VR group, specifically in the first 24 h after their larger, more painful, operations. Encouragingly though, despite their larger surgeries, the VR meditation group did show the predicted pattern of lower absolute pain and anxiety scores and fewer refills of their opioid prescriptions post discharge, (19.2 % for the VR group versus 26.9 % for the Non-VR group). It is important to note, however, that none of these findings were statistically significant, and we cannot draw definitive conclusions on this topic from the current data. However, the lack of statistical difference between groups when one group had larger and more complex surgeries may suggest some benefit to the VR that we were not able to capture with the current study design. A further point of interest is the question of distraction versus neuromodulation and how each plays a role in the application of VR in the perioperative setting. The majority of the current literature uses virtual reality as a distraction from pain, suggesting that using the device while feeling severe pain can reduce the nociceptive activation.10,11 This is challenging in the perioperative setting. Although postoperative pain is still considered ‘acute’ pain, the nociceptive experience is more likely to be longitudinal, over the course of at least a few days. As it is not reasonable to use a VR device constantly for several days, the best implementation of VR in the perioperative setting is uncertain. However, there are a few studies that suggest that virtual reality could be used to manage chronic pain via neuromodulation techniques rather than simply by distraction.9,13,15,16 As surgical pain falls somewhere between acute procedural and long-term chronic pain, it is hard to know when and how to apply VR to fall somewhere between these two strategies. The VR method used in this study was administered in set sessions almost as ‘doses’ rather than allowing patients to use the headsets on an as needed basis. This was done in an attempt to standardize the VR utilization but may have actually limited the benefit of the device, which might have had increased efficacy if patients were allowed to use it whenever they were experiencing acute pain or anxiety, rather than only at set times in their post-operative course. This study certainly has several limitations including the relatively small sample size and the wide variety of different surgical procedures included in the patient population, which would certainly be expected to have differing levels of perioperative pain. Our choice of a passive
benefits of virtual reality in other areas of medicine such as during labor, procedures or chemotherapy. “In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology”.6 Multiple studies in various fields of medicine have been able to demonstrate that the use of virtual reality can improve the experience of pain,7,9,10,14 reduce anxiety7,8 and reduce narcotic utilization in the acute setting.21 However, previous research that has dealt with the application of virtual reality to live clinical situations has struggled with multiple challenges including theoretical immaturity, a lack of technical standards, the problems of separating effects of media versus medium, practical in vivo issues, and cost, all of which have made the feasibility of large scale VR use somewhat questionable and were certainly encountered here.22 In this study, patients who participated in the VR program were usually able to complete all of the exercise, enjoyed using the device, had low pain, nausea and anxiety scores while using it, and experienced no major complications. The majority of patients who used the VR device responded that they would use VR again in the future (76.2 %) and would be interested in a virtual reality program designed specifically for pain control (62.0 %). There was very little cost to implement the virtual reality program and it was easily worked into standard work flows. Overall, VR is well received by patients and can be successfully implemented in a perioperative setting. While they make up the minority, it is interesting to consider the patients who did not accommodate well to the use of the VR device and did not enjoy it. Anecdotally, these patients frequently fell into one of two groups, either digital naïve or digital native.23 The digital naïve patients are those patients who do not regularly use technology, often the elderly individuals that make up a large portion of our patient population, and as a result are uncomfortable with the device. These patients tended to become easily confused or flustered during its use, leading to their dislike of it and in a few cases, their unwillingness to continue. The far opposite extreme that we noted was in the digital natives, young individuals who have grown up with advanced technology as second nature and who often found the very simple and straightforward meditation program that we chose (specifically so that all patients, including the digital naïve ones would be able to do it) too rudimentary to hold their attention. The population that specifically did not enjoy VR in this study also seemed to have undergone a higher proportion of more complex surgeries (almost exclusively large paraesophageal hernia repairs) and had a median age 10 years older than those who enjoyed using the VR device (71 versus 61 years). This does beg the question of which population is truly ideal for the application of a virtual reality program. Perhaps digital immigrants (those who have embraced new technologies but not been overwhelmed by them) will find such a device most useful, though better defining the target patient population will require additional investigation. 5
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Kevin M. Reavis: Conceptualization, Investigation, Writing - review & editing, Supervision. Daniel D. Bradley: Conceptualization, Investigation, Writing - review & editing, Supervision. Christy M. Dunst: Conceptualization, Methodology, Validation, Investigation, Resources, Writing - review & editing, Supervision, Funding acquisition.
meditation exercise may have also affected the outcomes as studies have shown that interactive virtual reality programs are more effective at reducing pain than simple passive experiences.12 It is also difficult to know with our chosen VR experience whether it is the VR itself or rather the meditation exercises that are primarily responsible for the results, as it is difficult to differentiate the effect of the media versus of the medium. This study is further limited by the population having consisted mostly of elderly women (digital naive), which makes generalizability a bit questionable. The Hawthorne effect may come into play as well with patients in this study as they are being asked so frequently about pain and anxiety with our frequent questionnaires that it may alter their perceptions and actions around their perioperative pain. To improve the effectiveness of VR integration in the future, there are certainly areas for potential improvement. Specific time in the preoperative setting should be protected so as to not interrupt nursing workflow. We found that education and buy in from all care team members helps significantly with the patient’s overall experience with VR. We feel that giving better instructions for use, and improving the integration of the VR device into the pre and post-operative workflow in non-disruptive ways could have improved our patient experience scores. In fact, the lack of improvement in satisfaction scores may be related to our very early experience in implementation, which resulted in some confusion and conflict around use of the device and likely negatively impacted the patient’s experience. Ultimately, while we have shown feasibility of implementing a VR program into perioperative care, additional larger studies will be required to determine if there are specific patient populations that will benefit most (such as digital immigrants or patients with anxiety or depression), different VR programs that might be more effective (those specifically designed for pain modulation, or those that are more interactive), or better ways in which to implement VR into standard workflows. Even given our overall equivocal results, it was promising to see that there were a few patients in particular who benefited dramatically from the use of the VR device, including a patient with chronic previous opiate addiction. This patient was very nervous about pain control and needing narcotics during his hospitalization and was hoping to avoid them as previous surgeries had caused him to lapse into abuse. Using the VR device, the patient was able to avoid the use of narcotics completely during his hospitalization and credits the device for his success.
Declaration of Competing Interest No author has any conflict of interest to disclose. Acknowledgements We would like to acknowledge the significant contributions of our office staff including Sarah Martinez who made numerous follow-up phone calls and was instrumental to our data collection as well as Angi Gill, our IRB coordinator, without whom this project would not have been possible. Appendix A. Supplementary data Supplementary material related to this article can be found, in the online version, at doi:https://doi.org/10.1016/j.ctim.2020.102356. References 1. Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic opioid dependence in the United States: Are surgeons the gatekeepers? Ann Surg. 2017;265(4):728–730. 2. Stoicea N, Costa A, Periel L, Uribe A, Weaver T, Bergese SD. Current perspectives on the opioid crisis in the US healthcare system: A comprehensive literature review. Medicine (Baltimore). 2019;98(20):e15425. 3. Webster LR, Brennan MJ, Kwong LM, Levandowski R, Gudin JA. Opioid abuse-deterrent strategies: Role of clinicians in acute pain management. Postgrad Med. 2016;128(1):76–84. 4. Honzel E, Murthi S, Brawn-Cinani B, et al. Virtual Reality, Music and Pain: Developing the premise for an interdisciplinary approach to pain management. Pain. 2019. 5. Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual reality as a clinical tool for pain management. Curr Pain Headache Rep. 2018;22(8):53. 6. Li L, Yu F, Shi D, et al. Application of virtual reality technology in clinical medicine. Am J Transl Res. 2017;9(9):3867–3880. 7. Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual reality-assisted pain, anxiety, and anger management in the emergency department. Telemed J E Health. 2019. https://doi.org/10.1089/tmj.2018.0273 [Epub ahead of print]. 8. Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017;63(12):932–934. 9. Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: A systematic review and meta-analysis. J Pain Res. 2019;12:2053–2085. 10. Maani CV, Hoffman HG, Fowler M, Maiers AJ, Gaylord KM, Desocio PA. Combining ketamine and virtual reality pain control during severe burn wound care: One military and one civilian patient. Pain Med. 2011;12(4):673–678. 11. Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual reality as a distraction intervention to relieve pain and distress during medical procedures: A comprehensive literature review. Clin J Pain. 2018;34(9):858–877. 12. Loreto-Quijada D, Gutiérrez-Maldonado J, Nieto R, et al. Differential effects of two virtual reality interventions: Distraction versus pain control. Cyberpsychol Behav Soc Netw. 2014;17(6):353–358. 13. Gupta A, Scott K, Dukewich M. Innovative technology using virtual reality in the treatment of pain: Does it reduce pain via distraction, or is there more to it? Pain Med. 2018;19(1):151–159. 14. Tashjian VC, Mosadeghi S, Howard AR, et al. Virtual reality for management of pain in hospitalized patients: Results of a controlled trial. JMIR Ment Health. 2017;4(1):e9. 15. Jones T, Moore T, Choo J. The impact of virtual reality on chronic pain. PLoS One. 2016;11(12):e0167523. 16. Garrett B, Taverner T, McDade P. Virtual reality as an adjunct home therapy in chronic pain management: An exploratory study. JMIR Med Inform. 2017;5(2):e11. 17. Sealed Envelope Ltd: Create a blocked randomization list. 2017. Accessed 8 Feb 2019. Available online: https://www.sealedenvelope.com/simple-randomiser/v1/ lists. 18. Thayaparan AJ, Mahdi E. The Patient Satisfaction Questionnaire Short Form (PSQ18) as an adaptable, reliable, and validated tool for use in various settings. Med Educ Online. 2013;18:21747. 19. Opiate Equianalgesic Dosing Chart. UNC Healthcare Guideline. University of North Carolina Hospitals Pharmacy & Therapeutics Committee. Accessed 28 July 2019. Available online: https://www.med.unc.edu/aging/files/2018/06/AnalgesicEquivalent-Chart.pdf. 20. Instructions for Scoring the PSQ-18. Accessed 28 July 2019. Available online:
5. Conclusion Virtual reality is a safe and simple intervention that is associated with high rates of patient satisfaction. While narcotic utilization was not statistically decreased in the current study, our overall experience suggests that this device holds promise as an adjuvant tool in the multimodal approach to pain and anxiety in the perioperative period and could make a meaningful impact for appropriately selected patients. Source of funding Portland IPA research grant. CRediT authorship contribution statement Kelly R. Haisley: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Resources, Data curation, Writing original draft, Writing - review & editing, Visualization, Project administration. Olivia J. Straw: Formal analysis, Data curation, Writing original draft, Visualization. Dolores T. Müller: Methodology, Validation, Formal analysis, Data curation, Writing - review & editing, Project administration. Michael A. Antiporda: Conceptualization, Methodology, Investigation, Writing - review & editing. Ahmed M. Zihni: Conceptualization, Investigation, Writing - review & editing. 6
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22. Garrett B, Taverner T, Gromala D, Tao G, Cordingley E, Sun C. Virtual reality clinical research: Promises and challenges. JMIR Serious Games. 2018;6(4):e10839. 23. Haluza D, Naszay M, Stockinger A, Jungwirth D. Digital natives versus digital immigrants: Influence of online health information seeking on the doctor-patient relationship. Health Commun. 2017;32(11):1342–1349.
https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/ psq/psq18_scoring.pdf. 21. McSherry T, Atterbury M, Gartner S, Helmold E, Searles DM, Schulman C. Randomized, crossover study of immersive virtual reality to decrease opioid use during painful wound care procedures in adults. J Burn Care Res. 2018;39(2):278–285.
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