BACKGROUND: Emergency department (ED) visits are known to be anxiety-ridden and stress-provoking experiences especially in the pediatric population. Distraction techniques have been used as a means to reduce anxiety and stress thereby facilitating care in the ED and making the visit less unpleasant. Our study aimed to evaluate the effectiveness of an active and immersive distraction technique, using a mindfulness-based virtual reality (VR) program (Take-Pause), to alleviate anxiety in pediatric ED patients. METHODS: A prospective, randomized, single-blinded study, evaluating ED patients aged 13-17 years with a chief complaint of acute pain was conducted. Patients were randomized either to the active distraction intervention (VR group), utilizing the VR headset for 5 min, or to the passive distraction intervention (iPad group), playing on an iPad for 5 min. The primary outcome was a difference in the change in anxiety scores on the Spielberger State-Trait Anxiety Inventory between the two groups. Secondary outcomes included a difference in pain scores, respiratory rate, and heart rate between the groups. RESULTS: A total of 110 subjects were enrolled. At 15 min, the mean anxiety score for the VR group improved by 10 points versus 6 points in the iPad group (p < 0.001; 95% confidence interval = 0.44 to 7.6). There was no statistical significance in the reduction of pain scores (p = 0.953) and respiratory rates (p = 0.776) between the groups. Patients enrolled in both groups did not experience any adverse effects. CONCLUSION: Take-Pause, offering an active and immersive distraction technique, is more effective than a passive distraction approach to lower anxiety levels in adolescent ED patients.