Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial.

Importance: The inclusion of digital therapeutics (eg, virtual reality [VR] systems) for the management of pain and anxiety associated with routine acutely painful medical procedures may have a substantial impact on treatment adherence and improve long-term health outcomes among young patients. Objective: To determine whether a VR intervention decreases pain and anxiety among patients undergoing peripheral intravenous catheter (PIVC) placement compared with standard care in the pediatric setting. Design, Setting, and Participants: This randomized clinical trial was conducted from April 12, 2017, to July 24, 2019, among 107 patients aged 10 to 21 years who were undergoing PIVC placement in 2 clinical settings (a radiology department and an infusion center) at an urban pediatric academic medical center in the US. Patients, caregivers, and clinicians completed pre-PIVC and post-PIVC placement questionnaires measuring patient pain, anxiety, and anxiety sensitivity; only participants with complete data from before and after PIVC placment were included in the analyses. Interventions: Patients were randomized to receive standard care (simple distraction techniques [eg, music, coloring, singing, and talking] and the application of numbing cream) or a VR intervention using a balanced computer-generated randomization scheme stratified by sex. All patients who received the VR intervention were offered concurrent standard care; however, VR plus standard care was not specifically examined. Main Outcomes and Measures: Primary outcomes were patient pain (measured by the Faces Pain Scale-Revised) and anxiety (measured by a visual analogue scale) reported by the patient, caregiver, and clinician after PIVC placement. Outcomes were analyzed using generalized linear modeling with backward stepwise selection for final model building. Results: A total of 107 patients (median age, 14.7 years [interquartile range, 12.8-16.9 years]; 63 male participants [58.9%]) completed the clinical trial; 54 patients received standard care, and 53 patients also received the VR intervention. Patients who received the VR intervention compared with standard care had significantly lower mean post-PIVC anxiety scores when patient-reported (1.85 points [95% CI, 1.28-2.41 points] vs 3.14 points [95% CI, 2.59-3.68 points]; P < .001) and clinician-reported (2.04 points [95% CI, 1.37-2.71 points] vs 3.34 points [95% CI, 2.69-3.99 points]; P = .002). Patients in the VR group vs the standard care group also had significantly lower mean post-PIVC pain scores when patient-reported (1.34 points [95% CI, 0.63-2.05 points] vs 2.54 points [95% CI, 1.78-3.30 points]; P = .002), caregiver-reported (1.87 points [95% CI, 0.99-2.76 points] vs 3.01 points [95% CI. 1.98-4.03 points]; P = .04), and clinician-reported (2.05 points [95% CI, 1.47-2.63 points] vs 3.59 points [95% CI, 2.97-4.22 points]; P < .001). Aside from lower levels of baseline pain and anxiety, no demographic variables among patients in the VR group were associated with lower levels of post-PIVC pain and anxiety. Conclusions and Relevance: In this randomized clinical trial, patients undergoing PIVC placement who received a VR intervention experienced significantly less anxiety and pain compared with those who received standard care. The use of patient, caregiver, and clinician data provided a variety of subjective information, as well as observable and objective data regarding perceived pain and anxiety beyond patient reporting alone. Trial Registration: ClinicalTrials.gov Identifier: CHLA-15-00549.

Temporal relationship between daily pain and actigraphy sleep patterns in pediatric sickle cell disease.

Limited research is available on the relationship between objective sleep patterns and pain in children with SCD. Research in other chronic pain populations suggests that the effect of sleep disruption on pain may be stronger than the effect of pain on sleep that night. To examine the bi-directional relationship between objective sleep patterns and daily pain in a pediatric SCD sample. Participants were 30 African American children with SCD 8-18 years (13 ± 2.8 years; 66.7% female) with frequent pain. Children and parents completed questionnaires to assess pain, medications, and depression/anxiety. Over a 14-day period, children completed a pain diary and ambulatory actigraphy monitoring to assess nighttime sleep (duration, efficiency and WASO). Greater pain severity was associated with worse sleep efficiency and greater WASO that night, controlling for age, sex, opioid medication, and depression/anxiety symptoms. Worse sleep efficiency was associated with the occurrence of pain and more severe pain the next day. There was no relationship between WASO and pain. Similarly, sleep duration did not influence pain. Results lend support for a bi-directional relationship between sleep parameters and daily pain in pediatric SCD, and identify sleep as a potential target for future research and intervention.