Development of a Neonatal Pain Assessment Tool for Clinician-Parent Collaboration

Thesis Abstract

In neonatal medicine, effective pain assessment is essential for minimizing stress and optimizing outcomes, yet current tools inadequately integrate clinician and parent perspectives, potentially underestimating infants’ pain and over-reliance on observable cues alone. This study aims to develop a neonatal pain assessment tool that structurally embeds clinician-parent collaboration to enhance accuracy, consistency, and family-centred care. The specific objectives are (1) to synthesize existing neonatal pain assessment instruments and identify dimensions receptive to caregiver input; (2) to elicit and integrate par­ent and clinician perspectives on pain indicators, communication needs, and decision-making processes; (3) to design a collaborative assessment instrument comprising objective physiological and behavioral indicators alongside parent-reported and clinician-annotated cues; (4) to pilot-test the new tool for feasibility, reliability, and validity in a neonatal intensive care unit (NICU) setting; and (5) to evaluate the tool’s impact on inter-rater reliability, care planning, and parental satisfaction. A mixed-methods approach is employed within a pragmatist paradigm, underpinned by the face validity and social constructivist theory of shared decision-making. The study unfolds in three phases. Phase I comprises a systematic review of existing neonatal pain scales and semi-structured interviews with 20 clinicians (neonatologists, nurses, and physiotherapists) and 20 parents of NICU infants to identify culturally and contextually relevant indicators and communication needs. Phase II involves instrument development a 48-item draft tool is created through synthesis of quantitative indicators (e.g., heart rate variability, facial grimace scales, crying duration) and qualitative inputs (parental worry indicators, clinician-noted cues), followed by expert content validation with a panel of 8 neonatology and pediatrics measurement scientists. Phase III is a multi-site pilot study in three NICUs with a total of 120 infant cases (<7 days to 28 days postnatal age) and associated caregiver participants to assess psychometric properties. Data collection employs (a) physiological monitors, video-recorded assessments for blinded coding, and parent-clinician questionnaires, (b) instrument administration by trained NICU staff, and (c) parental satisfaction scales. Data analysis includes exploratory factor analysis (EFA) to determine the instrument’s underlying structure, confirmatory factor analysis (CFA) to verify construct validity, and Cronbach’s alpha to evaluate internal consistency. Inter-rater reliability is examined using intraclass correlation coefficients (ICCs) for clinician and parent ratings. Regression modeling investigates the predictive validity of the tool against analgesic administration decisions and infant stress markers. Thematic analysis (Braun and Clarke) of qualitative data complements the quantitative findings to elucidate convergences and divergences in stakeholder perspectives. A convergent mixed-methods design enables integration of quantitative and qualitative results to refine the final instrument. Anticipated findings include a validated, user-friendly neonatal pain assessment tool with four domains physiological/behavioral indicators, parent-reported pain cues, clinician-annotated cues, and collaborative decision-making prompts. It is expected that the integrated domain will improve inter-rater reliability (target ICC > 0.80), increase accuracy of pain detection relative to standard scales, and enhance parental perceived involvement and satisfaction with care. The instrument should demonstrate acceptable model fit (CFI > 0.90, RMSEA < 0.08) and robust internal consistency (Cronbach’s alpha > 0.80 for key subscales). The study is likely to reveal that parent-reported cues add incremental validity beyond conventional indicators and that structured collaboration reduces incongruence between caregiver perceptions and clinical assessments. The study contributes to knowledge by providing a rigorously developed, clinically feasible tool that operationalizes clinician-parent collaboration in neonatal pain assessment, aligning with family-centred care principles and advancing measurement science in pediatric pain. It offers a validated framework for training clinicians in shared assessment practices and informs policy on NICU pain management protocols. Practical implications include improved pain recognition, earlier and more appropriate analgesia, standardized communication pathways, and higher family satisfaction. Limitations include potential variability across NICU settings and the need for broader cross-cultural validation. Recommendations for future research encompass longitudinal testing across diverse populations, integration with electronic health records, and evaluation of long-term developmental outcomes related to collaborative pain management in the neonatal period.