title: Parent participation in a childhood immunization pain reduction method.
abstract: OBJECTIVE
  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.
authors.affiliation: University of California San Francisco, San Francisco, CA, USA linda.franck@ucsf.edu.
authors.forename: Linda S
authors.initials: LS
authors.lastname: Franck
authors.affiliation: Pediatric Medical Group, Berkeley, CA, USA.
authors.forename: F Ralph
authors.initials: FR
authors.lastname: Berberich
authors.affiliation: University of Toronto, Toronto, ON, Canada.
authors.forename: Anna
authors.initials: A
authors.lastname: Taddio
mesh_terms: D000328:Adult; D002648:Child; D002675:Child, Preschool; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D008297:Male; D010146:Pain / Q000209:etiology* / Q000517:prevention & control*; D010147:Pain Measurement / Q000706:statistics & numerical data; D010290:Parents; D010358:Patient Participation / Q000523:psychology / Q000706:statistics & numerical data*; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011446:Prospective Studies; D014612:Vaccines / Q000009:adverse effects
chemical_list: D014612:Vaccines
keywords: childhood immunizations; pain management; parental satisfaction; primary care; vaccines