PROJECT SUMMARY
Mind-body therapies, like biofeedback (BF), are effective treatments to decrease pain in children and adults.
While decades of literature support the use of BF to decrease pain, BF is not currently available for use in the
postoperative period as it is a resource-rich intervention. With the help of novel technologic innovations, like
virtual reality (VR), BF can be delivered in an engaging, less resource-intensive manner, resulting in a more
accessible therapy that can be applied in broader clinical settings. VR has also demonstrated efficacy to
decrease pain, but transient reductions in pain due to the redirection of attention are insufficient to treat
prolonged acute pain experiences. FOREVR VR (Functional Outcome Response to Engaging VR) is a first-of-
its-kind, VR-based BF intervention and delivery system. Combining VR and BF (VR-BF) synergizes the
immersion and entertainment of VR with the physiological modifications of BF to enhance and sustain each
modality’s therapeutic effects. VR-BF is an engaging and motivating therapy that children can perform
independently and that has shown efficacy in treating several disorders. Despite early evidence of efficacy,
VR-BF is a new therapy and has not yet been employed in perioperative care, thus no optimal duration and
frequency or defined treatment protocols for preoperative training and postoperative application of VR-BF exist.
This study marks the first to assess the implementation and use of VR-BF in the perioperative setting and
seeks to establish measurable milestones that have not been addressed in prior studies. The goal of this two-
phase study is to understand how to implement a novel VR-BF therapy for postoperative pain management in
children. Before conducting an efficacy trial of VR-BF versus active control, it is imperative to assess factors
that will impact the VR-BF intervention and, consequently, the efficacy of VR-BF to reduce pain and opioid use.
Our central hypothesis is that the use of VR-BF in pediatric patients undergoing surgery resulting in moderate
to severe pain will be feasible and acceptable, and that findings from this pilot trial will inform design of a large-
scale efficacy trial of VR-BF in this patient population. Specific aims: (1) Refine a treatment protocol for
preoperative education and training and postoperative application of VR-BF using FOREVR VR in children and
adolescents undergoing surgery; and (2) Conduct a pilot randomized controlled trial to assess the feasibility
and acceptability of perioperative use of VR-BF using FOREVR VR in children and adolescents undergoing
surgery. The multidisciplinary research team, a unique collaboration of an anesthesiologist, pain experts,
clinical psychologists, a biostatistician, and a clinical trial design expert; are ideally suited to accomplish these
research goals. Data from this R34 will inform design of a large-scale, randomized, clinical efficacy trial using
VR-BF to assess pain and opioid reduction in children and adolescents with acute postoperative pain. It will
provide insight on preoperative education and training and postoperative application of VR-BF, in efforts to
improve postoperative analgesia, reduce opioid and analgesic use, and assist in pain and stress management.
