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NCT07834580

Perioperative Nursing Workload, Missed Care, and Near-Miss Events

Sponsor: Volkan Gokmen

View on ClinicalTrials.gov

Summary

This prospective, single-center observational study examines the relationship between perioperative nursing workload and safety-critical perioperative nursing care in the operating rooms of Agri Training and Research Hospital. Guided by the Donabedian structure-process-outcome framework, the study will directly observe eligible surgical procedures to record objective, procedure-level workload indicators (interruptions, task-switching, concurrent duties, procedure duration, shift timing, and equipment/supply shortages) together with the observed perioperative nurse's self-reported workload using the Turkish NASA Task Load Index (NASA-TLX), and a structured observation of nine safety-critical perioperative nursing care tasks (identification/procedure/site verification, allergy and critical preoperative information verification, positioning and pressure-injury prevention, normothermia, surgical counts, specimen/label verification, equipment and implant readiness, handoff, and documentation). Any delayed or omitted safety-critical care items, and any near-miss or process-deviation events identified and corrected before patient harm, will also be recorded using standardized forms. The study does not involve patients as direct research participants; only the perioperative work environment and voluntarily participating nurses are observed, and routine clinical care, staffing assignments, and surgical decisions will not be modified. The primary aim is to determine whether higher perioperative nursing workload is associated with a higher rate of missed/delayed safety-critical nursing care at the procedure level; secondary aims examine the association between missed safety-critical care and near-miss/process-deviation events, and, if sufficient events occur, whether missed safety-critical care mediates part of the relationship between workload and near-miss/process-deviation events.

Official title: Perioperative Nursing Workload, Missed Safety-Critical Care and Near-Miss Events: A Prospective Study Guided by the Donabedian Structure-Process-Outcome Model

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

330

Start Date

2026-10

Completion Date

2026-12

Last Updated

2026-09-24

Healthy Volunteers

Yes

Interventions

OTHER

Structured Direct Observation and Workload Assessment

No experimental intervention is administered. Eligible surgical procedures are directly observed by a researcher using a standardized Procedure and Objective Workload Observation Form and a structured Safety-Critical Perioperative Nursing Care Observation Form, and any near-miss/process-deviation events are recorded on a standardized log form. The observed perioperative nurse additionally completes the Turkish adaptation of the NASA Task Load Index (NASA-TLX) shortly after the procedure to assess self-reported workload. Routine clinical care, staffing assignments, and surgical decision-making are not modified by these observation and assessment procedures.

Locations (1)

Agri Training and Research Hospital

Ağrı, Turkey (Türkiye)