Enhanced surgical safety checklist implementation to improve safety culture among surgical and anesthesiology residents in a Romanian tertiary hospital

ISRCTN ISRCTN88241350
DOI https://doi.org/10.1186/ISRCTN88241350
Sponsor Ovidius University
Funder Investigator initiated and funded
Submission date
24/02/2026
Registration date
26/02/2026
Last edited
26/02/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Viorel Gherghina
Scientific, Principal investigator, Public

Tomis 147 Bl A3 Sc C Ap 46
Constanta
900502
Romania

ORCiD logoORCID ID 0000-0002-8695-6104
Phone +40 745222615
Email viorel.gherghina@365365univ-ovidius.ro
Ms Iuliana Cîndea
Scientific

Faculty of Medicine, Ovidius University of Constanta
Constanta
900502
Romania

Email iulia.cindea@365univ-ovidius.ro

Study information

Primary study designInterventional
AllocationNon-randomized controlled trial
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSingle
PurposeHealth services research, This study aims to assess the impact of an enhanced Surgical Safety Checklist educational program on safety culture perceptions among surgical and anesthesiology residents.
Scientific titleEnhanced surgical safety checklist implementation improves safety culture among surgical and anesthesiology residents: a prospective interventional study in a resource-limited tertiary hospital
Study objectivesPrimary objective
To determine whether an enhanced Surgical Safety Checklist implementation strategy improves safety culture perceptions (teamwork climate and safety climate SAQ domains) among surgical and anesthesiology residents after six months

Secondary objectives
1. To assess Surgical Safety Checklist compliance rates following enhanced implementation
2. To identify predictors of improvement in safety culture perceptions among residents
Ethics approval(s)

Approved 15/06/2024, Ethics Committee of the Emergency Clinical Hospital of Constanta (Bulevardul Tomis 145, Constanța, 900591, Romania; +40 241 503 245; spitaljudetean_cta@gmail.com), ref: 113/2024

Health condition(s) or problem(s) studiedPatient safety culture in surgical care
InterventionImplementation of an enhanced Surgical Safety Checklist program including:
Interactive SSC training session (2-hour structured education with simulation scenarios).
Structured postoperative feedback forms completed by residents after procedures.
Biweekly interdisciplinary mentorship sessions with senior surgeons and anesthesiologists.

Duration of intervention: 6 months.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Safety culture perceptions measured using Safety Attitudes Questionnaire (SAQ) teamwork climate and safety climate domain scores at Baseline (pre-intervention) and 6 months after implementation.
Key secondary outcome measure(s)
Completion date31/12/2024

Eligibility

Participant type(s)
Age groupAdult
Lower age limit24 Years
Upper age limit40 Years
SexAll
Target sample size at registration45
Total final enrolment45
Key inclusion criteriaSurgical and anesthesiology-intensive care residents rotating in the operating theatre of a tertiary emergency hospital during the study period and providing written informed consent.
Key exclusion criteriaPrior formal Surgical Safety Checklist training or fewer than 10 operating theatre shifts during the study period.
Date of first enrolment01/07/2024
Date of final enrolment31/07/2024

Locations

Countries of recruitment

  • Romania

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

25/02/2026: Trial's existence confirmed by Emergency Clinical Hospital of Constanta.