Dynamic assessment of pain, fear, and physiological stress during pediatric intravenous cannulation: a randomized controlled trial of virtual reality distraction

Most studies confirm the effectiveness of virtual reality (VR) in alleviating pain and fear during pediatric venipuncture, with limited evidence regarding physiological stress markers and dynamic assessment. This study aims to investigate the effects of VR technology on pain, fear, and physiological responses in children, as well as family satisfaction during intravenous cannulation. This single-blind randomized controlled trial was conducted in the Pediatrics Department of Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China. A total of 188 children requiring intravenous cannulation procedures and their families were allocated into: the control group ( n = 96), which received the conventional verbal comfort; and the experimental group ( n = 92), which wore VR headsets. The primary outcomes were dynamic fear/pain scores assessed by nurses and self-reported by patients, which were surveyed using the Children’s Emotional Manifestation Scale (CEMS) and the Children’s Fear Scale (CFS)/the Face, Legs, Activity, Crying, and Consolability scale (FLACC) and the Wong-Baker FACES Pain Rating Scale (Wong-Baker), respectively. The secondary outcomes were dynamic heart rate (HR) and peripheral oxygen saturation (SpO2) measurement, and family satisfaction levels. The pre-specified time points were pre-intervention, immediately post-intervention, at tourniquet application, at venipuncture, and one minute after venipuncture. Results were reported following the Consolidated Standards of Reporting Trials 2025 guidelines. VR significantly reduced children’s fear at two pre-venipuncture time points (nurse-assessed CEMS and child-reported CFS; partial η 2 = 0.072 and 0.053, both p < 0.05). There were no significant group effects in nurse-assessed FLACC and child-reported Wong-Baker pain scores across three venipuncture time points. However, a significant time-by-group interaction was observed for nurse-assessed FLACC scores (partial η 2 = 0.028, p = 0.006). Notably, nurse-assessed FLACC scores were lower than child-reported Wong-Baker scores in both control and experimental groups (Mean Diff.=-1.04 to -2.10, all p < 0.001). The dynamic changes in HR and SpO2 across five time points were lower within the experimental group (partial η 2 = 0.106 and 0.045, both p < 0.01). Partial correlation analysis revealed that family satisfaction responded to children’s pain, fear, and physiological stress in a “process-sensitive” pattern in the control group but an “outcome-oriented” pattern in the experimental group. In this trial, VR distraction effectively reduced procedural fear (but not pain) during venipuncture. However, the nurse assessment appears to suggest that the effects of VR distraction and conventional intervention on pain experience may vary over time. These findings underscore the importance of multidimensional pain/fear assessment in pediatrics. Our study confirms that VR distraction can significantly reduce fear in children undergoing intravenous cannulation, though pain scores were not significantly lowered. Multidimensional assessment (including subjective fear measures) is therefore important. VR may improve the patient and family experience of painful procedures. We recommend further trials with larger samples to confirm these findings and refine VR interventions. Chinese Clinical Trial Registry, ChiCTR2500113849 (Registration Date: Dec. 3, 2025; Retrospectively registered).