Communication in the Surgical Environment

December 1, 2025 updated by: Cintia Silva Fassarella

Communication in the Surgical Environment to Promote a Climate of Safety: Implementation of Evidence

The objective of this evidence implementation is to identify whether the implementation of a surgical briefing protocol promotes the strengthening of communication in the surgical environment of safety in the operating room among the orthopedic surgery team, including nurses, nursing technicians, orthopedic surgeons, and anesthesiologists.

The main question it seeks to answer is: does the surgical briefing protocol used to promote the strengthening of communication in the surgical environment and safety culture in the operating room comply with best practices? Participants will be asked to complete a baseline audit questionnaire, participate in training on the implementation of the surgical briefing protocol, and subsequently complete a follow-up audit questionnaire.

Study Overview

Status

Not yet recruiting

Detailed Description

The aim of the study is to identify whether the implementation of a surgical briefing protocol promotes the strengthening of the 'communication in the surgical environment' domain of safety climate in the operating room. A multi-method study is proposed to be developed in the surgical center of a university hospital located in the city of Rio de Janeiro. The study will be carried out in two phases: In Phase I, a surgical briefing protocol will be developed, validated and implemented that will follow the JBI (Joanna Briggs Institute) methodology of evidence implementation. As a support for methodological rigor, the tool SQUIRE2.0 (Standards for QUalityImprovement Reporting Excellence): revised publication guidelines from a detailed consensus process will be used. Finally, Phase II will have a quantitative approach with a cross-sectional design, using the Safety Attitudes Questionnaire/Operating Room (SAQ/OR). As a support for methodological rigor, the tool Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) will be used. The population will be composed of: nurses, nursing technicians, surgeons and anesthesiologists who work in orthopedic surgery and management of the unit. Regarding sampling, for Phase I of the study, a focus group will be constituted, called a working group (WG), adopting an intentional sampling, ensuring the participation of all health professional categories that work in orthopedic surgery. The inclusion criteria will be health professionals who work at least 20 hours per week, working in orthopedic surgeries and/or managers of the surgical center. For the validation stage, professionals withhigher education with specialization in the operating room (for nursing professionals) or orthopedic surgery (for medical professionals) will be adopted as inclusion criteria, as well as professors and researchers whose lines of research are directly related to surgical communication, patient safety and safety culture. For Phase II, a non-probabilistic sampling will be adopted, the sample calculation will be performed with the aid of the EpiInfo v5.5.9 application, adopting a confidence level of 95%. For this sample, health professionals who work at least 20 hours a week, who work directly or indirectly in patient care and who have been working in the sector for at least one month will be adopted as inclusion criteria. The exclusion criteria were the professionals who will compose the focus group. It is expected to implement a surgical briefing protocol and advance in the implementation of evidence to promote the maturation of the safety culture in the operating room, fostering safer surgical care, especially in this highly specialized sector that is the operating room. In addition to encouraging future studies involving the science of implementation in safety culture, allowing research to be truly focused on the best available evidence. It is intended that the research serves as a source of data on patient safety in the surgical environment and offers an innovative model to evaluate and intervene in complex aspects of the safety culture, involving professionals and senior management in health in the surgical environment.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil
        • UERJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: healthcare professionals who work at least 20 hours per week, directly or indirectly involved in patient care -

Exclusion Criteria: professionals with less than 30 days of experience in the sector

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: surgical team
Participants will complete an audit questionnaire before and after the implementation of the surgical briefing protocol.
Seminar on communication in the surgical environment with lectures and training on how to conduct surgical briefings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of improved safety climate in the operating room
Time Frame: From the registration period until the end of the protocol implementation, in 4 months
Quantitative data will be manually entered into a spreadsheet (Microsoft Excel®) and subsequently imported into the R program, version 4.2.1. The analysis will be performed using descriptive statistics (absolute and relative frequency) and mean and standard deviation. Blank items and "not applicable" items will be excluded from the analysis, as will questionnaires with the same answer to all questions. An improvement is considered if the mean is 75 or higher.
From the registration period until the end of the protocol implementation, in 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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