CMAJ. 2026 Sep 20;198(32):E1243-E1263. doi: 10.1503/cmaj.260123.
ABSTRACT
BACKGROUND: Distress (pain, fear) is the most common adverse reaction associated with vaccination. This 2026 guideline updates the 2015 Help ELiminate Pain in Kids & Adults (HELPinKids&Adults) Collaborative recommendations for reducing vaccination-related distress.
METHODS: We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to select the clinical questions and critical and important outcomes, and to determine the certainty of evidence and strength of the recommendations. We aligned guideline processes and reporting with the Appraisal of Guidelines for Research and Evaluation II tool. The intended audience includes clinicians and organizations that deliver vaccinations, and vaccine recipients and their support persons. Guideline panel members representing different knowledge user groups, including vaccine recipients and support persons, voted on clinical questions and outcomes. We categorized interventions into 5 domains of distress management, the 5Ps: process (education and implementation), procedural (injection techniques), physical (body position and activity), pharmacologic (medication), and psychological (thoughts and behaviour). Five systematic reviews combined evidence from randomized and quasi-randomized controlled trials identified using database (up to Jan. 31, 2025) and hand searching, supplemented by contacting experts. Evidence summaries were presented at a guideline meeting, and voting panel members drafted recommendations using the GRADE evidence-to-decision framework, considering certainty of the evidence, magnitude of effect, and contextual factors. We applied the Guidelines International Network principles to manage competing interests.
RECOMMENDATIONS: In the 5Ps framework, process-related interventions apply to all user groups. Procedural recommendations are directed at clinicians and organizations responsible for delivering vaccinations. Physical, pharmacologic, and psychological recommendations are targeted at vaccine recipients and support persons and incorporate choice. We developed 16 recommendations across the 5Ps framework, directed to different user groups. Of these, 7 are strong recommendations in favour of interventions (e.g., multicomponent process interventions, oral nutritive and non-nutritive interventions for infants), primarily supported by moderate- to high-certainty evidence. The remaining 9 are conditional recommendations based on low to very low certainty of evidence: 4 in favour of specific interventions (e.g., reducing fear cues) and 5 advising against other interventions (e.g., video or movie distraction in infants).
INTERPRETATION: This guideline presents evidence-based strategies to manage vaccination-related distress. Implementing recommendations can improve the quality of vaccine delivery and promote person-centred care by aligning interventions with vaccine recipient and support person preferences.
PMID:42767684 | DOI:10.1503/cmaj.260123