Abstract
INTRODUCTION: Children's medical fear refers to the negative emotional experiences, including fear, anxiety and nervousness, that arise when children are confronted with medical procedures and related events during healthcare encounters. This phenomenon exerts substantial negative impacts on treatment adherence, procedural cooperation and therapeutic outcomes, thereby emerging as a critical focus in modern paediatric medicine and psychiatric care. The establishment of precise assessment protocols serves as the cornerstone for developing effective intervention strategies. Despite the proliferation of assessment instruments targeting paediatric medical anxiety, there remains a notable paucity of rigorous methodological evaluation regarding their psychometric properties and clinical utility. This systematic review aims to bridge the existing gap between theoretical frameworks and clinical application by conducting a comprehensive evaluation of measurement properties of instruments designed to assess children's medical fear, with particular attention to their reliability, validity and clinical applicability across diverse patient populations and healthcare settings. METHODS AND ANALYSIS: This study protocol has been developed in strict accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines, ensuring methodological rigour and transparency. A comprehensive search of literature will be conducted across four English databases (PubMed, Web of Science, CINAHL via EBSCOhost and PsycINFO via ProQuest) and three Chinese databases (China National Knowledge Infrastructure, WanFang Data and SinoMed) from inception to 30 September 2025. The systematic review will incorporate comprehensive evaluation of measurement instruments assessing children's medical fear across multiple modalities, including self-report measures, observer-rated scales, behavioural observation protocols and semi-structured clinical interviews. The psychometric evaluation framework will encompass five critical domains: reliability, validity, responsiveness to clinical change, interpretability of scores and clinical utility in diverse healthcare settings. We will include primary quantitative studies published in English or Chinese. ETHICS AND DISSEMINATION: Ethics approval will not be required. The results of this systematic review will be submitted for publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD420250656564.