Perioperative Nursing Workload, Missed Care, and Near-Miss Events
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVolkan Gokmen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Actively on duty as a perioperative (operating room) nurse at Agri Training and Research Hospital
At least 3 months of operating room experience
Voluntary agreement to participate and to complete the post-procedure NASA-TLX form
Disqualifiers
Extended leave or medical report resulting in inactive duty during the data collection period
Withdrawal from the study
Failure to complete the post-procedure workload assessment form
Performed in the operating rooms of Agri Training and Research Hospital
Trial population
Perioperative (operating room) nurses working at Agri Training and Research Hospital, and the elective/planned surgical procedures in which participating nurses are actively on duty during the study period, meeting the eligibility criteria above. Patients undergoing the observed procedures are not direct research participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Structured Direct Observation and Workload Assessment
Other interventionNo 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.
Treatment groups
330 Participants
are divided into 1 treatment groupGroup A: Perioperative Nurses and Observed Surgical Procedures1 intervention
Trial outcomes
Primary outcomes
1
Missed Safety-Critical Perioperative Nursing Care Index
Proportion of applicable safety-critical perioperative nursing care items (patient/procedure/surgical-site verification, allergy and critical preoperative information verification, positioning and pressure-injury prevention, normothermia, surgical count, specimen/label verification, equipment/implant readiness, safe handoff, and required documentation) scored as delayed/partial or not done, divided by the total number of applicable safety-critical items for that procedure, as directly observed using the Safety-Critical Perioperative Nursing Care Observation Form.
Time frame
Assessed once per surgical procedure during the intraoperative period (from procedure start to end), for procedures observed over approximately 8-12 weeks between October 2026 and December 2026Secondary outcomes
1
Occurrence of Near-Miss/Process-Deviation Events
Occurrence of at least one near-miss or process-deviation event per procedure, defined as a safety deviation that was identified and corrected before patient harm and that required re-verification of a safety-critical process (for example, a count discrepancy requiring recount, late-identified missing equipment, information corrected during time-out, specimen/label correction, or late-completed handoff information), recorded using the Near-Miss and Process Deviation Log Form and evaluated for association with the Missed Safety-Critical Care Index.
Time frame
Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 20262
Total Objective Workload Events per Procedure
Total number of directly observed, procedure-level objective workload events, defined as the sum of the number of interruptions, interruption-related task-switching events, concurrent-duty events, and equipment/supply shortage events recorded on the Procedure and Objective Workload Observation Form. Association between this combined objective workload event count (Unit of Measure: events) and the Missed Safety-Critical Care Index will be evaluated using generalized linear mixed-effects models accounting for clustering of procedures within nurses, with procedure duration and shift timing included as adjustment covariates rather than as separate outcome measures.
Time frame
Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 20263
Perceived and Objective Perioperative Nursing Workload
Perceived perioperative nursing workload, measured using the raw score (arithmetic mean of the six subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration) of the Turkish adaptation of the NASA Task Load Index (NASA-TLX), completed by the observed nurse after each procedure, together with directly observed objective workload indicators (interruptions, task-switching events, concurrent-duty events, and procedure duration) recorded on the Procedure and Objective Workload Observation Form; and, if a sufficient number of near-miss/process-deviation events is reached, an exploratory multilevel mediation analysis of whether the Missed Safety-Critical Care Index explains part of the relationship between perioperative workload and near-miss/process-deviation events.
Time frame
Assessed once per surgical procedure, shortly after procedure completion, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Volkan Gokmen
Lead sponsor
Agri Ibrahim Cecen University
Sponsor institution
Source ClinicalTrials.gov
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