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BMJ Open logoLink to BMJ Open
. 2025 Nov 24;15(11):e101603. doi: 10.1136/bmjopen-2025-101603

Measurement properties of instruments to assess medical fear in children: a systematic review protocol

Jie Liu 1,✉,0, Tao Li 1,0, Mengting Zhu 2,0, Qiao Lin 1, Gu Jing 1, Dai Jinlan 1
PMCID: PMC12645607  PMID: 41290312

Abstract

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.

Keywords: Protocols & guidelines; Stress, Psychological; Review


STRENGTHS AND LIMITATIONS OF THIS STUDY.

  • This protocol adheres rigorously to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines and Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines to ensure the rigour of the methodology.

  • This study will systematically evaluate the measurement tools for children’s medical fear, providing references for clinical practice and subsequent research.

  • This study will assess publication bias through a combination of qualitative and quantitative methods and analyse the sources of heterogeneity through subgroup analysis and descriptive research to enhance the interpretability of the research results.

  • The exclusion of non-Chinese and non-English literature as well as grey literature may lead to biases in the research and affect the generalisability of the results.

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.1 This concept was initially introduced by Broome et al2 in 1994 and was subsequently introduced to the domestic academic community in 2000.3 Research has demonstrated that the mechanisms underlying medical fear in children are multidimensional, influenced by a variety of factors such as age, gender and environmental context.4 5 Notably, the level of medical fear exhibits dynamic changes across different stages of illness, with significant variations in the patterns of fear manifestation.6 This psychological phenomenon not only compromises children’s treatment adherence but also has the potential to significantly impede their recovery process. Consequently, it has emerged as a critical area of investigation in the fields of paediatric nursing and child psychology.

Medical fear exerts a profoundly negative impact on the treatment process and rehabilitation outcomes of children.7 Empirical studies have demonstrated that medical fear significantly diminishes children’s adherence to treatment and care, thereby adversely affecting their adaptation to medical interventions and overall disease outcomes.8 9 Furthermore, persistent medical fear may precipitate psychological sequelae such as post-traumatic stress disorder, leading to a cascade of long-term adverse consequences. These include growth and developmental delays, reduced social adaptability and other enduring effects that pose sustained risks to their physical and mental health development.10 Given these implications, the development and implementation of effective interventions to mitigate medical fear in children has emerged as a critical priority in contemporary paediatric and psychiatric care.

Systematic assessment of medical fear holds significant clinical and practical value. Through scientifically rigorous evaluation, healthcare professionals can accurately determine the level of children’s medical fear and identify specific fear sources, thereby enabling the effective identification of high-risk paediatric populations. This assessment process not only facilitates the exploration of multidimensional influencing factors underlying medical fear but also elucidates the correlational mechanisms between medical fear and negative emotional states such as anxiety and depression.5 11 Interventions tailored to assessment findings can enhance the precision and scientific rigour of care plans, significantly alleviating children’s fear experiences, reducing resistance and non-compliance during medical procedures and ultimately optimising the overall diagnostic and treatment experience.12

However, current assessment tools for children’s medical fear exhibit notable limitations. These instruments vary significantly in their dimensional constructs, item configurations and reliability indicators, and there is a lack of systematic comparative research and standardised guidelines. These shortcomings substantially hinder the scientific selection and effective application of assessment tools in clinical practice, limiting their utility and reliability in accurately measuring and addressing medical fear in paediatric populations.

Given the critical role of medical fear on children’s psychological development, medical behaviour and treatment outcomes, there is a need for a comprehensive evaluation of existing medical fear assessment tools for children. This systematic review is designed to address the existing challenges in the assessment of paediatric medical fear through a comprehensive evaluation and critical appraisal of currently utilised measurement tools. By systematically analysing the psychometric properties and clinical applicability of these instruments, we aim to identify the most valid, reliable and clinically relevant assessment methods. The findings of this review are expected to establish a standardised framework for medical fear evaluation, thereby enhancing the consistency and comparability of future research in this field. Ultimately, this work seeks to provide evidence-based guidance for healthcare professionals in selecting appropriate assessment tools, contributing to improved clinical practices and better psychological outcomes for paediatric patients.

This review is designed to address the following research question: What are the psychometric properties of the instruments currently utilised to assess medical fear in children? Through a rigorous systematic review, we aim to offer researchers and clinicians a detailed and critical evaluation of the strengths and limitations inherent in existing measures of paediatric medical fear. By synthesising evidence on reliability, validity and clinical utility, this review will provide evidence-based recommendations for selecting the most appropriate assessment tools. Such guidance is expected to enhance methodological rigour in future research and clinical practice, thereby fostering greater consistency and comparability across studies in the field of paediatric medical fear assessment. Ultimately, this work seeks to advance the quality of both research and clinical interventions, contributing to improved psychological outcomes for children facing medical challenges.

Methods

This systematic review protocol was developed in strict accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines.13 The completed PRISMA-P checklist, which documents our adherence to these reporting standards, is available in online supplemental S1 table. We plan to start the literature search on 30 September 2025. The study selection will be conducted from October 3 to November 3. Data extraction will take place from November 4 to December 10. Quality assessment will be carried out from December 11 to December 31. Synthesis of results and paper writing will be performed from January 2026 to 20 February 2026.

Eligibility criteria

To be eligible for inclusion in this systematic review, studies must satisfy the predefined criteria, which have been established in alignment with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Among these criteria, if multiple studies report on the same or overlapping data, only the most comprehensive study will be included. Such a study could be the one with the largest sample size, the most recent publication date or the most detailed reporting of measurement properties. Specific inclusion criteria are as follows:

Construct of interest

This review will include studies that develop, or validate, measurement instruments specifically designed to assess the construct of children’s medical fear.

Population of interest

This systematic review encompasses studies involving child patients receiving either outpatient or inpatient care across various healthcare settings, including but not limited to hospitals, clinics and specialised treatment centres.

Type of measurement instrument

The review will incorporate studies utilising validated measurement instruments that assess medical fear through multiple methodologies, including: (1) self-report measures, (2) observer-rated scales, (3) behavioural assessment tools, (4) multidimensional instruments and (5) semi-structured interview protocols.

Measurement properties

In accordance with the COSMIN guidelines, this review will systematically evaluate the psychometric properties of included measures across several critical domains: (1) reliability (encompassing internal consistency, test-retest reliability and inter-rater reliability), (2) validity (including content, construct and criterion validity), (3) responsiveness (the ability of a measurement instrument to detect clinically meaningful changes over time or in response to interventions), (4) interpretability and (5) clinical utility (the practical value of measurement instruments in real clinical or research settings). The methodological quality of each psychometric evaluation will be rigorously assessed using the COSMIN Risk of Bias checklist. Studies reporting any of these psychometric properties will be eligible for inclusion, with detailed documentation of the specific properties evaluated for each measurement instrument.

Eligible study types

The inclusion criteria for this systematic review are restricted to primary quantitative research studies that meet the following specifications: First, studies must explicitly state their primary objective as either (a) evaluating the psychometric properties of existing measurement instruments or (b) developing and validating new measurement tools, in accordance with established COSMIN guidelines.14 Second, considering the accuracy of translation and the extensiveness of Chinese and English literatures in this research field, only Chinese and English literatures will be included. Third, journal articles undergo strict editorial and peer review processes and have higher methodological transparency. However, grey literature often lacks the standardised methodological details of journal articles, and comprehensively identifying all relevant grey literature is methodologically complex and time-consuming. Therefore, we will only include journal articles to reduce the possibility of including low-quality or unvalidated studies.

Literature searches

This systematic review will be conducted and reported in strict adherence to the PRISMA guidelines. To ensure maximum search sensitivity, the formal literature search will employ a dual-strategy approach combining controlled vocabulary terms (eg, MeSH terms) with synonymous free-text keywords related to the core concepts of ‘medical fear’, ‘child patient’ and ‘measurement instruments’. While the search will be restricted to English or Chinese publications, no temporal restrictions will be applied, thereby enabling the identification of both historical and contemporary conceptualisations of medical fear in children.

To ensure comprehensive coverage, the research team will conduct forward citation tracking of all included studies to identify additional relevant literature. Prior to final manuscript submission, an updated database search will be performed to capture any recently published studies, ensuring the review reflects the most current evidence in the field. If revisions to the original study protocol are required during the search update process, we will keep detailed records of the amendment content. After joint review and confirmation by all members of the research team, a new section titled ‘Protocol Deviations’ will be added to the final manuscript, systematically illustrating the specific details of the amendments. Meanwhile, since this study has been registered on the PROSPERO platform, we will promptly update the corresponding registration information on the platform after the protocol amendments are confirmed, ensuring that the registered information on the platform is fully consistent with the actual implementation process of the study.

The comprehensive search strategy employs a four-pronged approach, systematically combining distinct search components through the Boolean ‘AND’ operator to ensure precision and recall. This structured methodology focuses on the following key dimensions:

Population: ‘child*’, ‘pediatric*’, ‘adolescent*’, ‘Youth*’

  1. Exposure: ‘medical fear*’, ‘hospital anxiety*’, ‘healthcare-related fear*’, ‘dental fear*’

  2. Instruments: ‘assessment*’, ‘checklist*’, ‘instrument*’, ‘inventor*’, ‘measure*’, ‘questionnaire*’, ‘scale*’, ‘score*’, ‘survey*’, ‘test*’, ‘tool*

  3. Psychometric properties: ‘validity*’, ‘reliability*’, ‘responsiveness*’, ‘sensitivity*’, ‘applicability*’, ‘interpretability*’, ‘utility*’

The comprehensive literature search will be systematically executed across seven major electronic databases, comprising four international English-language databases (PubMed, Web of Science, CINAHL via EBSCOhost and PsycINFO through ProQuest) and three authoritative Chinese databases (China National Knowledge Infrastructure, WanFang Data and SinoMed). This dual-language, multi-platform approach ensures extensive coverage of both Western and Chinese scholarly literature. A standardised search protocol will be implemented across all databases to maintain methodological consistency, with the complete search strategy for PubMed presented in table 1 as an illustrative example of our systematic approach.

Table 1. Comprehensive search strategy for Pubmed.

Step Concept Search terms
#1 Medical fear (medical fear*) or (hospital anxiety*) or (healthcare-related fear*) or (dental fear*)
#2 Children (‘child*’[mn]) or (pediatric*) or (adolescent*) or (Youth*)
#3 Assessment tools (assessment*) or (checklist*) or (instrument*) or (inventor*) or (measure*) or (questionnaire*) or (scale*) or (score*) or (survey*) or (test*) or (tool*)
#4 Psychometric properties (validity*) or (reliability*) or (responsiveness*) or (sensitivity*) or (applicability*) or (interpretability*) or (utility*)
#5 Combination #1 and #2 and #3 and #4
#6 Language limit Limit #5 to English and Chinese language

Study selection

Following the initial search (stage 1), two more stages will follow (figure 1).

Figure 1. Flow diagram of the study selection process.

Figure 1

Title and abstract selection

In the second stage, a rigorous dual-reviewer process will be implemented for title and abstract screening. Two independent reviewers will conduct parallel assessments of all identified records to ensure methodological rigour. Prior to full-scale screening, the reviewers will complete a calibration exercise involving the first 100 citations to establish inter-rater reliability and ensure consistent application of the predefined inclusion/exclusion criteria. Any discrepancies arising during the screening process will be initially addressed through consensus discussions between the primary reviewers. In cases where consensus cannot be achieved, a third senior reviewer will be engaged to adjudicate and make the final determination.

Full-text selection

The third stage will involve full-text assessment, conducted independently by the same two reviewers to maintain consistency in the evaluation process. Each reviewer will meticulously examine the complete articles against the predefined eligibility criteria. Any disagreements in study selection will be initially resolved through structured consensus discussions between the primary reviewers. In instances where consensus remains unattainable, the third reviewer will serve as an arbiter to make the final determination, thereby ensuring an objective and rigorous selection process.

Data extraction

Two independent reviewers will conduct data extraction using a standardised, purpose-designed form specifically developed for this systematic review of children’s medical fear. The structured extraction form will systematically capture six key domains1: general study information: including authorship details, publication title, journal information, publication year and funding sources2; methodological characteristics: encompassing study design, research setting, study duration, county, application site and sample size parameters3; participant demographics: documenting age distribution, gender representation, clinical diagnoses, illness duration and symptom severity profiles4; measurement instrument details: specifying the name, type, item structure, scoring methodology and dimensional framework of the medical fear assessment tools.

Psychometric properties: evaluating reliability indices, validity evidence, responsiveness metrics and interpretability parameters6; associated outcome measures: including treatment adherence and doctor-patient relationship metrics.

The data extraction form will undergo pilot testing using a representative sample of included studies, with subsequent refinements implemented to optimise its effectiveness. Following independent data extraction, reviewers will conduct reconciliation meetings to compare completed forms, resolving discrepancies through consensus-based discussions or, when necessary, through consultation with a third reviewer. In instances where critical data elements are missing, corresponding authors will be contacted to obtain the required information. This rigorous, multi-step approach ensures the collection of comprehensive and accurate data, encompassing not only fundamental study characteristics and participant demographics but also detailed documentation of children’s medical fear measurement instruments, including their psychometric properties and clinical applicability. Such thorough data collection is essential for critically evaluating the measurement tools’ validity, reliability and practical utility in assessing children’s medical fear.

Quality assessment

Two independent reviewers will rigorously evaluate the methodological quality of included studies using the COSMIN Risk of Bias checklist for Patient-Reported Outcome Measures (PROMs), a validated tool specifically developed for assessing the methodological rigour of studies examining measurement properties. The checklist will be appropriately adapted to accommodate clinician-rated measures when necessary. The COSMIN checklist systematically evaluates key measurement properties, including reliability (internal consistency, test-retest reliability, inter-rater reliability), validity (content, construct and criterion validity), responsiveness and interpretability. For each included study, reviewers will critically appraise the methodological quality of reported measurement properties, with particular attention to whether the statistical analyses employ Classical Test Theory or Item Response Theory frameworks, applying appropriate methodological standards for each approach. Quality assessments will be conducted using the COSMIN’s standardised 4-point rating scale: ‘very good’, ‘adequate’, ‘doubtful’ and ‘inadequate’. Each measurement property reported in the studies will receive an independent rating based on this scale. To ensure consistency and reliability in the assessment process, any discrepancies between reviewers’ ratings will be resolved through structured consensus discussions, with unresolved cases being adjudicated by a third independent reviewer.

In conjunction with the COSMIN checklist, reviewers will conduct a comprehensive risk of GRADE (Grading of Recommendations, Assessment, Development and Evaluations) assessment for individual studies, systematically evaluating key methodological factors including: (1) adequacy of sample size and power calculations, (2) rigour of participant selection and recruitment procedures and (3) appropriateness of methods for handling missing data. Furthermore, the overall quality of evidence for each measurement property across studies will be evaluated using a modified GRADE approach specifically adapted for psychometric studies. This dual assessment framework will enable a rigorous evaluation of both individual study quality and the collective strength of evidence for each measurement property.

To assess potential publication bias, reviewers will employ a comprehensive qualitative evaluation approach that combines qualitative evaluation with statistical methods. This qualitative evaluation will involve (1) systematic examination of result patterns across studies, with particular attention to the prevalence of exclusively positive findings; (2) critical appraisal of the search strategy’s comprehensiveness in capturing both published and unpublished studies; and (3) meticulous scrutiny of individual studies for evidence of selective outcome reporting or data suppression. For the statistical methods, when a sufficient number of studies (at least 10) report on the same psychometric property, funnel plots will be constructed. If the funnel plot is not symmetrical, it will be interpreted as potential evidence of publication bias. This multi-faceted assessment will enable the identification of potential biases that could affect the validity and generalisability of the review’s conclusions.

The review team will conduct a rigorous assessment of the generalisability of findings, systematically evaluating three key dimensions: (1) demographic and clinical characteristics of study populations, (2) contextual factors surrounding the administration of medical fear measures (including healthcare settings and cultural considerations) and (3) methodological limitations explicitly acknowledged by study authors. This comprehensive quality appraisal framework will enable the identification of medical fear measurement instruments demonstrating optimal psychometric properties while simultaneously providing critical insights into the strengths, limitations and potential biases within the current evidence base for children’s medical fear.

Given that the included studies may differ in design, setting and population, we will conduct a preliminary exploration of heterogeneity based on study type, demographic characteristics, measurement tools and methods for assessing psychometric properties. In addition, subgroup analyses will be performed based on these factors to investigate the potential sources of heterogeneity.

Synthesis of results

A comprehensive evidence synthesis table will be systematically developed to summarise key characteristics of all included studies. This table will encompass four critical domains: (1) methodological design features, (2) demographic and clinical sample characteristics, (3) specific details of medical fear measurement instruments (including psychometric properties and administration protocols) and (4) reported clinical and psychosocial outcomes. This structured presentation will provide both a detailed mapping and a synthesised overview of the current evidence base regarding measurement instruments for children’s medical fear, facilitating comparative analysis and identification of research gaps.

Distinct outcome tables will be systematically developed to present psychometric evidence for each medical fear measurement instrument and outcome construct. These tables will provide a detailed synthesis of reported measurement properties, including: (1) reliability indices (internal consistency, test-retest reliability, inter-rater reliability), (2) validity evidence (content, construct and criterion validity), (3) responsiveness metrics and (4) interpretability parameters. Additionally, a comprehensive classification table will be created to organise measurement instruments according to their primary assessment focus and specific dimensions of medical fear evaluated. This structured presentation will enable clear comparison of instruments’ conceptual frameworks and measurement approaches, facilitating the identification of appropriate tools for specific clinical or research applications.

To facilitate a comprehensive evaluation of available measurement tools, we will construct a detailed quality assessment matrix. This matrix will systematically organise and present critical information for each included medical fear measurement instrument, including: (1) measurement modality (self-report, clinician-rated or multi-informant); (2) frequency of use across studies; (3) population characteristics (diagnostic categories, age ranges and clinical settings); (4) COSMIN quality ratings for each psychometric property (utilising the 4-point rating scale: very good, adequate, doubtful, inadequate); and (5) overall strength of evidence based on the modified GRADE approach. This structured matrix will serve as a practical decision-making tool, enabling researchers and clinicians to efficiently identify the most psychometrically robust medical fear measurement instruments tailored to specific research contexts and clinical populations. The visual presentation of comparative quality data will enhance the utility of our systematic review by providing clear, at-a-glance guidance for instrument selection in paediatric medical fear assessment.

A comprehensive narrative synthesis will be developed to contextualise and interpret our findings. This synthesis will (1) provide an overview of the current landscape of paediatric medical fear measurement; (2) critically evaluate the psychometric strengths and methodological limitations of existing instruments; (3) identify significant gaps in the current evidence base; (4) offer evidence-based recommendations for measure selection across diverse research and clinical settings; and (5) propose prioritised directions for future methodological development in medical fear assessment.

This multi-faceted approach to evidence synthesis and knowledge translation will yield a clear, accessible and clinically relevant overview of paediatric medical fear measurement. By integrating quantitative findings with qualitative insights, our synthesis will serve as a practical guide for researchers and clinicians, facilitating informed selection of measurement instruments and advancing the field through targeted recommendations for future psychometric research.

Discussion

In this protocol, we delineate a rigorous methodological framework for conducting a systematic review of measurement instruments designed to assess children’s medical fear. This comprehensive evaluation holds significant importance for multiple compelling reasons. Children’s medical fear represents a multifaceted psychological construct that has undergone substantial conceptual evolution and diverse operationalisation across different research paradigms. The progressive refinement in our understanding of this phenomenon underscores the critical need for a meticulous assessment of existing measurement tools. Such evaluation is imperative to ensure these instruments maintain conceptual relevance and measurement precision in capturing the contemporary understanding of children’s medical fear, particularly in light of recent theoretical advancements and empirical findings in paediatric psychology.

The manifestation of children’s medical fear exhibits substantial interindividual variability, presenting a complex challenge for accurate assessment and measurement. This heterogeneity is influenced by a constellation of developmental and contextual factors, including but not limited to maturational stage, cognitive developmental level, inherent temperament characteristics and the quality of emotional support systems. Such multidimensional influences necessitate the development and application of psychometrically robust measurement tools that possess sufficient sensitivity to capture the full spectrum of this variability while maintaining diagnostic precision across diverse paediatric populations.

Children’s medical fear carries substantial clinical significance, exerting profound impacts on multiple dimensions of healthcare delivery and patient outcomes. Empirical evidence has consistently demonstrated its critical associations with treatment compliance trajectories, therapeutic efficacy and rehabilitation processes. This clinical relevance underscores the imperative for rigorously validated assessment instruments that meet the highest psychometric standards. Such measurement tools must demonstrate robust reliability, discriminant and convergent validity and sufficient sensitivity to detect clinically meaningful changes. These psychometric properties are essential for both longitudinal monitoring of fear progression and the evaluation of intervention effectiveness across diverse clinical contexts and developmental stages.

The evaluation of children’s medical fear typically employs a multimodal assessment framework, incorporating both self-reported measures and clinician-rated instruments. This dual-method approach capitalises on their complementary strengths while mitigating individual limitations through methodological triangulation. Self-report measures offer valuable insights into the child’s subjective experience and internal states, whereas clinician-rated instruments provide objective behavioural observations and professional clinical judgments. Given the methodological complexity and contextual variability in assessment scenarios, a systematic evaluation of existing measurement tools becomes imperative. Such a comprehensive review would facilitate evidence-based selection of assessment instruments, enabling researchers and clinicians to optimise their measurement strategies according to specific research objectives, clinical populations and situational requirements.

With the rapid evolution of medical technology and paradigm shifts in healthcare delivery, children’s medical anxiety has emerged as a critical focus in contemporary healthcare. Medical professionals, serving as primary healthcare providers, have assumed a pivotal role in identifying, evaluating and addressing children’s medical-related fears. The growing emphasis on assessing children’s medical anxiety among healthcare practitioners in recent years represents a significant advancement in healthcare quality, underscoring a comprehensive approach to paediatric patients’ physical and psychological well-being. This paradigm shift reflects the medical community’s heightened awareness of the intricate relationship between emotional well-being and treatment outcomes in paediatric care.

In response to these critical methodological and clinical imperatives, we have undertaken a comprehensive systematic review designed to advance the scientific understanding and measurement of children’s medical fear. This rigorous examination of psychometric instruments represents a pivotal step in establishing an evidence-based framework for instrument selection and application. By systematically evaluating the methodological quality, clinical utility and psychometric properties of existing measures, this review aims to provide empirically grounded guidelines that will enhance both research validity and clinical decision-making in paediatric healthcare settings.

By providing a comprehensive overview of available children’s medical fear measures, their psychometric properties and their applicability in different contexts, we aim to facilitate more informed decision-making in the selection and use of these tools. This, in turn, will contribute to more robust research in the field and potentially lead to improved clinical assessment and care for children’s medical fear.

Through a systematic synthesis and critical appraisal of existing children’s medical fear assessment instruments, including their psychometric characteristics and contextual applicability, this review endeavours to establish an evidence-based decision-making framework for instrument selection and implementation. The anticipated outcomes of this rigorous evaluation extend beyond methodological refinement, potentially catalysing significant advancements in both empirical research and clinical practice. By enhancing measurement precision and clinical relevance, this initiative aims to foster more methodologically sound investigations while simultaneously informing the development of targeted interventions and personalised care strategies for child patients experiencing medical fear.

In conclusion, this systematic review addresses a critical knowledge gap by providing a comprehensive synthesis of contemporary evidence regarding children’s medical fear assessment. The resultant findings are poised to make dual contributions: theoretically, by advancing methodological frameworks for future investigations, and practically, by informing evidence-based clinical protocols for assessment and intervention strategies in paediatric healthcare settings. This integration of research and practice perspectives ultimately aims to optimise both measurement precision and therapeutic outcomes for child patients experiencing medical fear.

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.

Supplementary material

online supplemental file 1
bmjopen-15-11-s001.docx (22.3KB, docx)
DOI: 10.1136/bmjopen-2025-101603

Footnotes

Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-101603).

Patient consent for publication: Not applicable.

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

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    Supplementary Materials

    online supplemental file 1
    bmjopen-15-11-s001.docx (22.3KB, docx)
    DOI: 10.1136/bmjopen-2025-101603

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