Background & Aims

XR, namely virtual and augmented reality (VR and AR), as a nonpharmacological treatment for pain has accelerated in the last decade1. VR transposes the user to an alternative real or computer-generated environment, while AR enhances an existing physical environment with additional virtual objects embedded in that real setting. XR allows users to engage completely in immersive, gamified, and interactive digital experiences1-4. The consistent use of appropriate outcome measures and high-quality trials are critical to advancing care of pediatric and adult patients in acute and chronic pain using XR. To date, no standardized approach to assessing outcomes of XR-based interventions for pain exists. Our aim was to recommend a core outcome set (COS) of domains and measures for pediatric and adult acute and chronic pain XR intervention trials.

Methods

We employed a multi-phase approach, consisting of a systematic review of the literature, Delphi survey, and in-person consensus conference to generate a core outcome set for XR trials for pain management. In the first phase we conducted two systematic reviews on XR in acute and chronic pain trials in (1) pediatrics and (2) adults, respectively, to identify the most common core outcome domains assessed and reported on in the literature. These data then informed the second phase, a Delphi survey of clinicians and researchers using XR for pain treatment. In the third phase, a two day in person meeting was held to reach consensus on recommended outcome domains for adult and pediatric acute and chronic pain XR clinical trials. This was followed by a second round of the Delphi survey to broaden consensus.

Results

In Phase I, the systematic review yielded n=90 pediatric studies and n=106 adult studies. Feasibility, safety, and effectiveness were evaluated variably across studies, with pain intensity and emotional functioning emerging as the most common outcomes. The Delphi survey (Phase II) revealed similar trends with pain intensity and distraction the most assessed outcomes. Additionally, high importance was placed on the evaluation of safety for XR. In Phase III, by unanimous vote, and consistent with the OMERACT framework5-6, pain severity, adverse events, user experience, and psychological constructs were identified as mandatory domains to be assessed in all trials for acute and chronic pain, with the addition of pain interference for chronic pain trials. Physiological markers and physical function were deemed important to consider but optional domains. Additional emerging areas for future research did not obtain sufficient support in the consensus process but were noted.

Conclusions

The use of XR for pain management is becoming increasingly prevalent and initial research is promising for XR use across the lifespan with different types of pain (acute, and chronic). Therefore, like other recommendations for COS in pediatric and adult trials for acute and chronic pain7, we need a COS to inform the design and evaluation of XR interventions for all types of pain across the lifespan. Results of this multiphase consensus building processes produced several core outcome domain recommendations for XR trials in pediatric and adult acute and chronic pain populations. Areas for future consensus and research were also identified, and a multiphase project is underway to provide recommendations for appropriate validated measures to assess each of the established outcome domains in XR trials This presentation will outline findings from the three phases of the current consensus building process and highlight ongoing work toward advancing XR trial research.

References

1.Pavithra A, Kowsalya J, Keerthi Priya S, Jayasree G, Nandhini TK. An emerging immersive technology-A survey. International Journal of Innovative Research In Technology. 2020;6(8):119-130.
2.Gandolfi E. Virtual reality and augmented reality. Handbook of Research on K-12 Online and Blending Learning 2018.
3.Sidiq M, Lanker T, Makhdoomi K. Augmented reality VS virtual reality. International Journal of Computer Science and Mobile Computing. 2017;6(6):324-327.
4.Székely G, Satava RM. Virtual reality in medicine. BMJ: British Medical Journal. 1999;319(7220):1305.
5.Beaton D, Maxwell, L., Grosskleg, S., Shea, B., Tugwell, P. The OMERACT Handbook Version 2.1. OMERACT; 2021. https://omeract.org/handbook/
6.Boers M, Idzerda L, Kirwan JR, et al. Toward a Generalized Framework of Core Measurement Areas in Clinical Trials: A Position Paper for OMERACT 11. The Journal of Rheumatology. 2014;41(5):978-985. doi:10.3899/jrheum.131307
7.Palermo, T. M., Walco, G. A., Paladhi, U. R., Birnie, K. A., Crombez, G., de la Vega, R., … & Stone, A. L. (2021). Core outcome set for pediatric chronic pain clinical trials: results from a Delphi poll and consensus meeting. Pain, 162(10), 2539-2547.

Presenting Author

Courtney W. Hess

Poster Authors

Courtney W. Hess, PhD

PhD

Stanford University School of Medicine

Lead Author

E-mail

Giulia Mesaroli

MScPT

SickKids and University of Toronto

Lead Author

E-mail

Brittany Rosenbloom

PhD

Women's College Hospital

Lead Author

E-mail

Cristal Lopez

PhD

Children's Hospital Los Angeles

Lead Author

E-mail

Nhat Ngo

BS

Children's Hospital Los Angeles

Lead Author

E-mail

Estreya Cohen

BA

York University

Lead Author

E-mail

Carley Oulette

RN

McMaster University

Lead Author

E-mail

Jeffrey Gold

PhD

Children's Hospital Los Angeles

Lead Author

E-mail

Laura Simons

PhD

Stanford University School of Medicine

Lead Author

E-mail

Jennifer Stinson

PhD

SickKids and University of Toronto

Lead Author

E-mail

Deirdre Logan

PhD

Boston Children's Hospital and Harvard University

Lead Author

E-mail

Topics

  • Evidence, Clinical Trials, Systematic Review, Guidelines, and Implementation Science