Abstract
Background and purpose
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.Methods
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.Results
VR significantly reduced children's fear at two pre-venipuncture time points (nurse-assessed CEMS and child-reported CFS; partial η2 = 0.072 and 0.053, both p 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 2 = 0.106 and 0.045, both p Conclusions
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.Implications for nursing management
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.Trial registration
Chinese Clinical Trial Registry, ChiCTR2500113849 (Registration Date: Dec. 3, 2025; Retrospectively registered).