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

NCT07834580 | Not Yet Recruiting

• 1 other identifier: AICU-MISSEDCARE-2026
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Missed Nursing Care; Patient Safety; Workload

Keywords

Donabedian Model; Perioperative Nursing; Safety-Critical Care; Near-Miss; NASA-TLX

Outcome Measures

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.

  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 2026

Secondary Outcomes (3)

• Occurrence of Near-Miss/Process-Deviation Events

  Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026

• Total Objective Workload Events per Procedure

  Assessed once per surgical procedure during the intraoperative period, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026

• Perceived and Objective Perioperative Nursing Workload

  Assessed once per surgical procedure, shortly after procedure completion, for procedures observed over approximately 8-12 weeks between October 2026 and December 2026

Study Arms (1)

Perioperative Nurses and Observed Surgical Procedures

Perioperative nurses working in the operating rooms of Agri Training and Research Hospital who voluntarily consent to participate, together with the eligible elective/planned surgical procedures in which a participating nurse is actively on duty during the study period. Each eligible procedure is directly observed by a researcher using a standardized objective workload observation form and a structured safety-critical perioperative nursing care observation form; near-miss/process-deviation events are logged using a standardized form; and the observed nurse completes the Turkish NASA Task Load Index (NASA-TLX) shortly after the procedure. No experimental intervention, diagnostic test, or change to routine clinical care is assigned; participants are observed under usual perioperative practice.

Other: Structured Direct Observation and Workload Assessment

Interventions

Structured Direct Observation and Workload Assessment OTHER

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.

Perioperative Nurses and Observed Surgical Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Involves a participating perioperative nurse who is actively on duty
• Elective or planned surgical procedure
• At least a portion of the safety-critical care items are directly observable
• Emergency/resuscitative circumstances that would affect the clinical flow being observed
• Procedures in which observation could not be completed
• Observation records missing core variables

Sponsors & Collaborators

• Volkan Gokmen: lead

Study Sites (1)

Agri Training and Research Hospital

Ağrı, Turkey (Türkiye)

Location

Related Publications (14)

• Association of periOperative Registered Nurses (AORN). Guidelines for Perioperative Practice. Current edition. Denver, CO: AORN.

  BACKGROUND

• Wheelock A, Suliman A, Wharton R, Babu ED, Hull L, Vincent C, Sevdalis N, Arora S. The Impact of Operating Room Distractions on Stress, Workload, and Teamwork. Ann Surg. 2015 Jun;261(6):1079-84. doi: 10.1097/SLA.0000000000001051.

  PMID: 26291954 BACKGROUND

• Healey AN, Sevdalis N, Vincent CA. Measuring intra-operative interference from distraction and interruption observed in the operating theatre. Ergonomics. 2006 Apr 15-May 15;49(5-6):589-604. doi: 10.1080/00140130600568899.

  PMID: 16717011 BACKGROUND

• El-Jardali F, Lagace M. Making hospital care safer and better: the structure-process connection leading to adverse events. Healthc Q. 2005;8(2):40-8. doi: 10.12927/hcq..17048.

  PMID: 15828566 BACKGROUND

• Palese A. Missed Nursing Care Entering Its Academic Maturity: A Call for Conceptual Renewal and Research Innovation. J Adv Nurs. 2026 Jul;82 Suppl 2:S180-S184. doi: 10.1111/jan.70517. Epub 2026 Jan 30. No abstract available.

  PMID: 41618524 BACKGROUND

• Liu Q, Lu Y, Zhai S, Dai C, Kan C, Chen C. Workflow Interruptions, Perceived Workload and Missed Nursing: Their Impact on Nurses' Health Status-A Structural Equation Model. J Adv Nurs. 2026 Jan;82(1):311-320. doi: 10.1111/jan.16855. Epub 2025 Feb 24.

  PMID: 39991959 BACKGROUND

• Rostami K, Pourdel B, Hosseini SA, Rajabi E, Alizadeh A. Sleep quality, quality of work life, and missed perioperative nursing care among operating room technologists: a multicenter cross-sectional study. BMC Nurs. 2026 Jul 21. doi: 10.1186/s12912-026-05044-6. Online ahead of print.

  PMID: 42477678 BACKGROUND

• Ge W, Zhu T, Li M, Zhu X, Wang H. Missed nursing care in the operating room: a qualitative analysis of nurses' perspectives. BMC Nurs. 2026 Apr 21;25(1):503. doi: 10.1186/s12912-026-04672-2.

  PMID: 42015199 BACKGROUND

• Kalisch B, McLaughlin M, Marsh V, Nguyen L, Talsma A. The Development and Testing of the MISSCARE Survey OR. J Nurs Meas. 2021 Dec 1;29(3):541-555. doi: 10.1891/JNM-D-19-00039. Epub 2021 Sep 13.

  PMID: 34518391 BACKGROUND

• Gillespie BM, Harbeck E, Chaboyer W. The frequency and reasons for missed nursing care in Australian perioperative nurses: A national survey. J Clin Nurs. 2025 Mar;34(3):883-893. doi: 10.1111/jocn.17082. Epub 2024 Feb 21.

  PMID: 38380764 BACKGROUND

• Jones TL, Hamilton P, Murry N. Unfinished nursing care, missed care, and implicitly rationed care: State of the science review. Int J Nurs Stud. 2015 Jun;52(6):1121-37. doi: 10.1016/j.ijnurstu.2015.02.012. Epub 2015 Feb 23.

  PMID: 25794946 BACKGROUND

• Kalisch BJ, Landstrom GL, Hinshaw AS. Missed nursing care: a concept analysis. J Adv Nurs. 2009 Jul;65(7):1509-17. doi: 10.1111/j.1365-2648.2009.05027.x. Epub 2009 May 9.

  PMID: 19456994 BACKGROUND

• Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. In P. A. Hancock & N. Meshkati (Eds.), Human Mental Workload (pp. 139-183). North-Holland.

  BACKGROUND

• Sonmez B, Oguz Z, Kutlu L, Yildirim A. Determination of nurses' mental workloads using subjective methods. J Clin Nurs. 2017 Feb;26(3-4):514-523. doi: 10.1111/jocn.13476. Epub 2016 Aug 15.

  PMID: 27434614 BACKGROUND

Study Officials

• Burcu Demir Gokmen, PhD

  Agri Ibrahim Cecen University

  PRINCIPAL INVESTIGATOR

• Volkan Gokmen, PhD

  Agri Ibrahim Cecen University

  STUDY DIRECTOR

Central Study Contacts

Burcu Demir Gokmen, PhD

CONTACT

+90 506 751 6888; vgokmen@agri.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)