Communication in the Surgical EnvironmentNCT07246226
Communication in the Surgical Environment
A study testing Surgical communication training in people with Communication in the Surgical Environment, run by Cintia Silva Fassarella at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication in the Surgical Environment
- What is being tested?
- Surgical communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2025to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Surgical communication training
- Keywords
- Organizational Culture, Implementation Science, Patient Safety, Surgicenters, Patient Care Team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical communication trainingBehavioural
Seminar on communication in the surgical environment with lectures and training on how to conduct surgical briefings
| Study group | Role | What they receive |
|---|---|---|
| surgical team | Other | Participants will complete an audit questionnaire before and after the implementation of the surgical briefing protocol. Receives: Behavioral: Surgical communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of improved safety climate in the operating room
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.
Measured: From the registration period until the end of the protocol implementation, in 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Dec 2025
- Primary completion30 Jan 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication in the Surgical EnvironmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cintia Silva Fassarella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cintia Silva Fassarella, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246226
- Sponsor's protocol ID
- 7.924.577
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication in the Surgical Environment to Promote a Climate of Safety: Implementation of Evidence
- ClinicalTrials.gov ID
- NCT07246226
- Acronym / sponsor ID
- 7.924.577
- Keywords
- Organizational Culture, Implementation Science, Patient Safety, Surgicenters, Patient Care Team
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cintia Silva FassarellaUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical team | Other | Behavioral: Surgical communication trainingParticipants will complete an audit questionnaire before and after the implementation of the surgical briefing protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical communication trainingSeminar on communication in the surgical environment with lectures and training on how to conduct surgical briefings | Behavioural | surgical team |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical communication training in people with Communication in the Surgical Environment, run by Cintia Silva Fassarella at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.