title: Process Interventions for Vaccine Injections: Systematic Review of Randomized Controlled Trials and Quasi-Randomized Controlled Trials.
abstract: BACKGROUND
  This systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination.
  
  
  METHODS
  Databases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR).
  
  
  RESULTS
  Thirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07).
  
  
  CONCLUSIONS
  Educating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination.
authors.affiliation: *Department of Psychology, York University †Department of Psychiatry, the Hospital for Sick Children ‡Department of Psychiatry, University of Toronto §§Departement of Neonatology ∥Child Health and Evaluative Sciences, Hospital for Sick Children §Leslie Dan Faculty of Pharmacy, University of Toronto ‡‡Faculty of Medicine, University of Toronto ††Mount Sinai Hospital, Toronto ¶Department of Psychology, University of Guelph, Guelph #Children's Health Research Institute, Children's Hospital **Department of Paediatrics, Western University, London, ON ¶¶Department of Pediatrics and Psychology, Faculty of Science, Dalhousie University ##IWK Health Centre, Halifax, NS, Canada ∥∥Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Pillai Riddell
authors.forename: Anna
authors.initials: A
authors.lastname: Taddio
authors.forename: C Meghan
authors.initials: CM
authors.lastname: McMurtry
authors.forename: Vibhuti
authors.initials: V
authors.lastname: Shah
authors.forename: Melanie
authors.initials: M
authors.lastname: Noel
authors.forename: Christine T
authors.initials: CT
authors.lastname: Chambers
mesh_terms: D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D006801:Humans; D007267:Injections / Q000009:adverse effects*; D010146:Pain / Q000209:etiology / Q000523:psychology / Q000534:rehabilitation; D013811:Psychotherapeutic Processes; D011613:Psychotherapy / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D014611:Vaccination / Q000009:adverse effects*