NCT07572448

Brief Summary

This study will be conducted to determine the relationship between the perception of safety culture among healthcare professionals working in an outpatient surgical unit and the level of safety patients feel during surgery performed under local anesthesia. The study population consists of healthcare professionals (N = 140) working in the Day Surgery Unit of Bursa Uludağ University Faculty of Medicine Hospital and patients undergoing procedures. The sample size calculation for the healthcare professionals to be included in the study was determined using the known population sampling method. Using the Raosoft sampling method, with a 5% margin of error and a 95% confidence interval, the minimum required sample size (n) was calculated to be 103. It was decided that the study would include healthcare professionals and patients in a 1:1 ratio. Therefore, the total sample size was calculated to be 206. Data will be collected using the Hospital Survey on Patient Safety Culture (Version 2.0) and the Feeling Safe During Surgery Scale.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Safety cultureFeeling safe

Outcome Measures

Primary Outcomes (2)

  • Nurses' level of patient safety culture

    It will be calculated using scores from the sub-dimensions of the Hospital Survey on Patient Safety Culture (Version 2.0).

    From the registration phase to the end of the approximately 52-week data collection process

  • Patients' Sense of Safety

    The score range on the Patient Safety During Surgery Scale is 13-130 points.

    From the registration phase to the end of the approximately 52-week data collection process

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare professionals working in the day surgery unit and patients undergoing procedures under local anesthesia

You may qualify if:

  • Currently working as a healthcare professional in an outpatient surgical unit,
  • No visual, auditory, or psychological impairments that would prevent them from completing the questionnaires and scales,
  • At least a graduate of a vocational high school for healthcare professions,
  • Patients scheduled for elective surgery under local anesthesia,
  • Patients and nurses who voluntarily agreed to participate in the study.

You may not qualify if:

  • Refusal to voluntarily participate in the study,
  • Presence of any visual, auditory, or psychological impairments that would prevent the completion of questionnaires and scales,
  • Individuals who are not healthcare professionals.
  • Patients undergoing emergency surgical procedures or those under general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 7, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 7, 2026

Record last verified: 2026-05