Virtual reality (VR) is a promising non-pharmacological pain intervention because it may not only distract but also modulate pain by immersing the user in a three-dimensional 360° alternate reality. In children, VR has been reported to reduce clinical pain and anxiety during medical procedures. However, the effect of immersive VR on pain and anxiety remains to be investigated in randomized controlled trials (RCT). The aim of the present crossover RCT was to assess the effect of VR on pressure pain threshold (PPT) and anxiety level measured with the modified Yale Preoperative Anxiety Scale (mYPAS) in children in a controlled experimental setting. Seventy-two children (mean age 10.2 (6-14) years) were randomized to 24 sequences of four interventions (immersive VR Game, immersive VR video, tablet: 2D video and control: small talk). Outcome measures PPT, mYPAS and heart rate were assessed before and after each intervention. PPT increased significantly during VR game (PPTdiff): 136 kPa (CI 112; 161), p < 0.0001 and VR Video (PPTdiff): 122 kPa (CI 91; 153), p < 0.0001. Also, anxiety levels significantly decreased during both VR game (mYPASdiff: -7 points (-8 to -5), p < 0.0001) and VR video (mYPASdiff: -6 points (CI -7; -4), p < 0.0001). VR had a marked beneficial effect on PPT and anxiety compared with the control interventions: 2D video and small talk. Thus, immersive VR had a distinct modulatory effect on pain and anxiety in a well-controlled experimental setting. Immersive VR was effective and feasible in children and can act as a valid tool for non-pharmacological pain and anxiety management. Paediatric immersive VR seems to be beneficial although well-controlled studies are pending. We investigated whether immersive VR can modulate children's threshold for pain and anxiety level in an experimental well-controlled setting. We document a modulatory pain threshold increase and anxiety level decrease compared with extensive control conditions. Paediatric immersive VR is effective, feasible and valid for non-pharmacological pain and anxiety management. All efforts to reach the goal that no child should experience pain or anxiety when exposed to medical procedures.
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