Virtual Reality for SCD VOC

Vaso‐occlusive crisis is a common and debilitating complication of sickle cell diseaseand is a frequent reason for treatment in acute care settings, including infusion centersand emergency departments. Opioid analgesics remain the mainstay of treatment for acutevaso‐occlusive pain, but many patients continue to experience substantial pain, distress,and functional impairment despite standard therapy. Scalable, low‐risk, non‐pharmacologicadjuncts are needed to improve pain management during acute vaso‐occlusive episodes.Virtual reality is a promising non‐pharmacologic approach to pain management that mayreduce pain through immersive distraction, modulation of attention, and enhanced patientengagement. Prior studies suggest that virtual reality may reduce acute and chronic painin some clinical settings, but the effect may vary by population and condition. Limiteddata are available regarding the use of virtual reality for acute vaso‐occlusive pain inadults with sickle cell disease. This study is designed to evaluate the feasibility,tolerability, and preliminary analgesic effect of headset‐based visual and audiointerventions during infusion center treatment of vaso‐occlusive crisis.This is a randomized, controlled, two‐period crossover pilot study using a balancedincomplete block design. Participants will be enrolled during routine outpatient sicklecell disease clinic visits when they are clinically stable and not experiencing an acutevaso‐occlusive crisis. After enrollment, participants will be eligible to receive studyinterventions during future qualifying infusion center visits for vaso‐occlusive painoccurring within the study follow‐up window. At each qualifying visit, study staff willconfirm continued eligibility, medical appropriateness, and the participant's willingnessto proceed before delivering the assigned intervention.Each participant will be randomized to receive two of three headset‐based interventionconditions across two separate qualifying infusion center visits. The three conditionsare: sham 2D headset control, consisting of non‐interactive 2D visual content displayedon a fixed virtual screen with standardized audio; passive immersive 3D virtual reality,consisting of 360‐degree or 3D immersive visual content with standardized audio withoutcontroller‐based interaction; and active immersive interactive 3D virtual reality,consisting of immersive interactive virtual reality content with standardized audio andlow‐motion, seated controller‐based interaction. Each intervention session is planned tolast 45 minutes and will be delivered in addition to usual clinical care forvaso‐occlusive crisis.Randomization will assign each participant to one of three possible intervention pairs:sham 2D plus passive 3D virtual reality, sham 2D plus active interactive 3D virtualreality, or passive 3D virtual reality plus active interactive 3D virtual reality. Withineach pair, the order of interventions will be randomized to balance period and sequenceeffects. Participants and study staff will not be blinded to the intervention conditionbecause the interventions are perceptible; however, use of a headset‐based controlcondition and standardized scripts is intended to reduce differences in attention andexpectancy across conditions.The primary outcome is pain burden during the first 60 minutes after intervention start,measured as area under the curve of 0‐10 numeric rating scale pain scores. Pain scoreswill be collected before the intervention and at 15, 30, 45, and 60 minutes afterintervention start. Secondary and exploratory outcomes include pain at 120 minutes,change in pain from baseline to 120 minutes, opioid administration summarized as morphinemilligram equivalents, need for rescue analgesia, feasibility of intervention delivery,session completion, missing pain assessments, early discontinuation, headset‐relatedsymptoms, perceived immersion, and participant‐reported likelihood of using theintervention again during future vaso‐occlusive crisis treatment.The study will enroll an anticipated convenience sample of approximately 20 to 25participants based on the expected eligible infusion center population during the studyperiod. The primary purpose of this pilot study is to estimate feasibility, tolerability,effect size, and variability to inform the design of a future larger efficacy trial.