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Aim: Few previous studies have examined the effects of the distraction approach by focusing on children under five years of age receiving immunizations. This study was conducted to examine the effects of distraction designed to reduce 3 to 4 year-old children’s pain during immunizations. Methods: Participants were 102 children aged 3 to 4 years who were given an immunization in an urban pediatric clinic in Japan. They were randomly assigned to one of three groups, which either 1) watched an animated DVD (Animation group; n = 35), 2) received interactive intervention using picture cards (Card group; n = 34) or followed a standard office routine (Control group; n = 33). Videotapes were recorded to observe children’s behavior during the immunization. Pain measurements at four phases (baseline, during preparation, during injection, and following injection) were made using the Face Legs Activity Cry and Consolability (FLACC) behavioral pain scale. Parents rated their child’s anxiety prior to procedure and during the procedure on a Visual Analogue Score (VAS). Results: There was a significant difference between prior to procedure and during the procedure VAS scores only in the control group (p = 0.021). In the three groups, the FLACC scores increased significantly from baseline to during preparation (Animation group: p = 0.002, Card group and Control group: p < 0.001). However, from during preparation to during injection, the FLACC score of only the Animation group increased significantly (p = 0.001). From during injection to following injection, the FLACC scores in the three groups showed a significant decrease (p < 0.001 in each of the three groups). Conclusion: Immunizations are painful procedures for children that cause considerable pain and anxiety. Watching cartoons and interactive distraction do not seem to be effective in reducing high levels of pain.

Reducing Pain Associated with Immunization in Three- to Four- Year- Old Children: A Randomized Clinical Trial