Cedars-Sinai study on inpatient VR pain management offers glimpse at real-world outcomes

Positive data from the pragmatic study is the clearest evidence yet that in-hospital therapeutic VR could be effective in a live deployment, according to researchers.
By Dave Muoio
02:06 pm
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Therapeutic virtual reality is not only an effective approach for hospital inpatients experiencing a wide variety of pain, but likely retains its impact when provided over multiple days under real-world circumstances, according to a new Cedars-Sinai clinical study published today in PLoS One.

“There’s been decades of research testing VR in highly controlled environments — university laboratories, the psychology department and so on,” Dr. Brennan Spiegel, director of health services research at Cedars-Sinai and the study’s lead author, told MobiHealthNews. “This study is really letting VR free and seeing what happens. What I mean by that is it’s a pragmatic study where we didn’t want to control every single element of the study, but literally just see [what would happen] if we were to give it to a broad range of people in the hospital with pain; how would it do compared to a control condition already available in the hospital?”

This strength — alongside the substantial size of the patient population, variety of pain types included and direct comparison to an existing multimedia intervention — helps make the clearest case yet for VR’s clinical potential within the hospital, Spiegel continued, and paves the way for live deployments of the technology as part of inpatient care.

“We don’t need more science at this point to justify deploying VR in the hospital or creating virtualist consult services in the hospital. We’ve got enough evidence now, in my opinion, to begin using this in the inpatient environment,” he said. “The challenge will be staffing it, scaling it, paying for it and so on — and those are important challenges — but I don’t think science is the challenge anymore.”

TOPLINE DATA

The difference in pre- and post-intervention pain scores was significantly greater (P < .04) among VR patients (n = 61) than among those who received a control (n = 59), an effect that was more apparent when limiting the analysis to a subgroup of patients reporting higher levels of pain (p = .02).

After adjusting for pre-intervention pain, type of pain, age and other variables, analyses indicated a greater incremental reduction in pain among VR patients (n = 61) at 48-hour (P = .03) and 72-hour (P = .04) post-intervention periods when compared to those who received a control (n = 59).

Three patients in the intervention group reported transient dizziness during a VR session that was resolved after removing the headset, and no significant treatment-related adverse events occurred in either group. Patients in the VR group reported much greater satisfaction with their provided content (P < .001), while global measures of care were more similar between the groups.

Opioid prescription remained similar between the groups both before and after deployment of the intervention, an outcome that Spiegel said was unsurprising when considering how the VR intervention was deployed.

“On the one hand, that might seem disappointing to VR aficionados that we didn’t move pain meds in the study,” he said. “On the other hand, … it’s a lot to ask for VR headsets to change prescribing behaviors, unless it’s part of a protocol where people decide to use VR first before they start prescribing and dispensing opioids. In this study we didn’t make any rules or requirements whatsoever for anyone to change how they use opioids, and so it turns out there was no change in opioid use.

These results do not apply to outpatient deployment of VR as a pain management therapy, an area that Spiegel said is the next step for upcoming clinical research.

HOW IT WAS DONE

Researchers randomly provided 120 hospitalized adult patients with either a Samsung Gear Oculus headset and onboard Galaxy S7 smartphone with 21 on-demand VR experiences, or an in-room TV displaying health and wellness content. Researchers included patients if they characterized their pain with a three-out-of-ten or higher average rating in the 24 hours before screening, and if there were no obstructive injuries or history of motion sickness or nausea. After receiving instruction on their operation, participants were advised to use the VR headsets three times a day for 10 minutes per session, while clinical staff were instructed to care for the patients as usual.

“We didn’t just give VR once. We kept VR at the bedside throughout the hospital stay, so we monitored patients for up to 72 hours,” Spiegel said.

The team’s primary outcome of interest was changes in patient-reported pain levels immediately after initial treatment, and after 48 and 72 hours. Secondary measures included patient satisfaction with the hospital’s pain-management care and with the experiences themselves, as well as any differences in opioid prescription rates.

This approach provided the study with unique strengths that other investigations of therapeutic VR have so far lacked, Spiegel explained.

In particular, minimal interactions with study staff outside of initial patient instruction, direct comparison to a control intervention with potential benefits and the variety of pain types among the participants each helped trial scenario emulate the conditions in which therapeutic VR would be deployed.

Worth noting was the substantial gap between the 591 patients evaluated for participation to the 120 enrolled, the team wrote. These patients dropped off due to study ineligibility or no interest in the novel digital approach, a point that the researchers stressed when highlighting the general applicability of the data, and of therapeutic VR itself.

“Patients expressed varying degrees of skepticism, fear, sense of vulnerability, concern regarding psychological consequences, or simply not wanting to be bothered by using the equipment,” they wrote. “We believe it is important for the digital health community to recognize that despite the great promise of health technology, clinical realities can undermine expectations.”

THE BACKGROUND

Pain management has been a go-to implementation of VR among providers for some time, with a number of studies and reviews being published over the years highlighting the technology’s early potential. This has also led to a handful of deals between manufacturers, developers and health providers.

But VR has also been tapped for a wealth of other use cases outside of pain management, including surgeon training, patient education, anxiety management and much more.

IN CONCLUSION

“Although previous research has demonstrated therapeutic benefits of VR for pain, there has been no prospective, randomized, adequately powered, pragmatic trial of VR versus an active control in hospitalized patients,” the researchers wrote. “In this study, we found that on-demand use of VR in a diverse group of hospitalized patients was well tolerated and resulted in statistically significant improvements in pain versus a control group exposed to an in-room ‘health and wellness’ television channel. These results build upon earlier studies and further indicate that VR is an effective adjunctive therapy to complement traditional pain management protocols in hospitalized patients."