Parent Participation in a Childhood Immunization Pain Reduction Method

Abstract

Objectives. This randomized controlled trial evaluated the effectiveness, feasibility, and acceptability of parent participation (PP) in an evidence-based method to reduce the pain of prekindergarten immunizations. Methods. Healthy children aged 4 to 6 years were randomized to a multimodal distraction method during administration of routine vaccines with PP and 1 medical assistant (experimental group) or 2 medical assistants (standard-of-care comparison group). Children and parents rated the pain after injections, and a blinded observer coded children’s pain from videotapes. Results. In all, 76 children participated. Despite group randomization, more children in the medical assistant–only group received a 3-injection series (25; 68%) than in the PP group (6 [15%], P = .001). After adjustment for this imbalance, child-reported pain was higher in the PP group compared with the medical assistant–only group (2.95 vs 1.75; F = 5.87; df = 1.66; d = 0.64; P < .02). There were no differences between groups for parent-reported and observer-rated measures of pain or in intervention fidelity, duration of procedure, or child or parent satisfaction. Conclusions. Although child-reported pain was higher for the PP group, the magnitude of the difference may not be clinically significant. PP was feasible and acceptable to both parents and children, did not take any longer, and reduced the need for additional medical personnel. Together, these data provide preliminary support for PP for prekindergarten immunization pain management.