Disruptive BehaviorNCT05113147
Disruptive Behavior in the Operating Room
An observational study of Disruptive Behavior, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Background: The operating room (OR) environment presents specific conditions that put stress on work dynamics. Disruptive behavior (DB) among members of the health team is recognized to affect work dynamics and patient outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Disruptive Behavior
- What is being tested?
- In-depth individual interviews
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 20 Mar 2018to 30 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Twenty participants included (surgeons n = 12, anesthetists n = 2, residents n = 2, nurses n = 2, technicians n = 2).
Who may be able to join
- Health members working in the operating room.
Who cannot join
- Less than one year of experience in the operating room.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disruptive Behavior in the Operating Room: Systemic Over Individual Determinants
Background: The operating room (OR) environment presents specific conditions that put stress on work dynamics. Disruptive behavior (DB) among members of the health team is recognized to affect work dynamics and patient outcomes. The objective was to explore the perceptions of different members of the health team, including surgeons, about the occurrence of DB and the work dynamics in the OR.
Study design: Qualitative exploratory study, based on semi structured individual interviews. Twenty participants were sampled until data saturation, including surgeons, anesthetists, nurses among other. Data extraction from verbatim transcriptions was performed by investigators via qualitative analysis software, using grounded theory framework.
Read the detailed description
METHODS
A qualitative exploratory study was carried out within an analytical and relational framework of the contents [19,20]. The study was approved by a Scientific Ethics Committee (project ID: 15-340) and meets the quality standards for reporting qualitative Research (COREQ checklist).
Selection of participants Intentional theoretical sampling was performed, which considered the representation of different members of the health team to seek maximum heterogeneity.
The inclusion criterion was that the health members had at least one year of experience in the operating room. Participants were included until achieving data saturation from the information obtained.
Data collection In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management. The final version of the script was reached after the first four interviews. Once the adjustments were made, the same script was used with the other participants.
The interviews were conducted by two interviewers (DZ and MC) with experience in this collection technique and who were not linked to the activities of the health team that was the subject of this study. The information was collected in 2017 and 2018. The participants were invited by email, and once they signed an informed consent, which explained the research´s goal and information about their participation. Once they agreed to participate, the interviewers interviewed an office face-to-face to guarantee privacy and confidentiality. Interviews lasted an average of 45 minutes, and all were audio-recorded and later transcribed verbatim.
Data analysis The participants' responses were analyzed with open and axial coding, based on the grounded theory model to relate the categories emerging from the responses.
Grounded theory is based on the analysis of the narrative contained in the interviews. This in turn leads to the development of codes, categories and themes based on the descriptions to culminate in hypotheses of how these themes interact. Atlas.ti v8.0 software was used for the data analysis (ATLAS.ti Scientific Software Development GmbH, Lietzenburger Str. 75, D-10719 Berlin, Germany).
Six researchers from the team collaborated in the analysis of the transcripts through an iterative process of intersubjective data triangulation sessions until definitive categories and guiding questions were reached regarding the phenomenon under study.
After the analysis, all participants received an email, who explained the findings and asked for feedback (member checking).
- Conditions
- Disruptive Behavior
- Being tested
- In-depth individual interviews
- Keywords
- Disruptive Behavior, Patient Safety, Operating Room, Surgeons, Effective Teamwork, Organizational Culture, Qualitative Study
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-depth individual interviewsOther
In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions about the occurrence of disruptive behaviors and the work dynamics in the operating room
In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management
Measured: Up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Mar 2018
- Primary completion20 Mar 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive BehaviorStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jesus Lira, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113147
- Sponsor's protocol ID
- 15-340
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the confidentiality of the participants, interview transcripts will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disruptive Behavior in the Operating Room: Systemic Over Individual Determinants
- ClinicalTrials.gov ID
- NCT05113147
- Acronym / sponsor ID
- 15-340
- Conditions
- Disruptive Behavior
- Keywords
- Disruptive Behavior, Patient Safety, Operating Room, Surgeons, Effective Teamwork, Organizational Culture, Qualitative Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 9 Nov 2021 (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.
Background: The operating room (OR) environment presents specific conditions that put stress on work dynamics. Disruptive behavior (DB) among members of the health team is recognized to affect work dynamics and patient outcomes. The objective was to explore the perceptions of different members of the health team, including surgeons, about the occurrence of DB and the work dynamics in the OR.
Study design: Qualitative exploratory study, based on semi structured individual interviews. Twenty participants were sampled until data saturation, including surgeons, anesthetists, nurses among other. Data extraction from verbatim transcriptions was performed by investigators via qualitative analysis software, using grounded theory framework.
Detailed description
METHODS
A qualitative exploratory study was carried out within an analytical and relational framework of the contents [19,20]. The study was approved by a Scientific Ethics Committee (project ID: 15-340) and meets the quality standards for reporting qualitative Research (COREQ checklist).
Selection of participants Intentional theoretical sampling was performed, which considered the representation of different members of the health team to seek maximum heterogeneity.
The inclusion criterion was that the health members had at least one year of experience in the operating room. Participants were included until achieving data saturation from the information obtained.
Data collection In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management. The final version of the script was reached after the first four interviews. Once the adjustments were made, the same script was used with the other participants.
The interviews were conducted by two interviewers (DZ and MC) with experience in this collection technique and who were not linked to the activities of the health team that was the subject of this study. The information was collected in 2017 and 2018. The participants were invited by email, and once they signed an informed consent, which explained the research´s goal and information about their participation. Once they agreed to participate, the interviewers interviewed an office face-to-face to guarantee privacy and confidentiality. Interviews lasted an average of 45 minutes, and all were audio-recorded and later transcribed verbatim.
Data analysis The participants' responses were analyzed with open and axial coding, based on the grounded theory model to relate the categories emerging from the responses.
Grounded theory is based on the analysis of the narrative contained in the interviews. This in turn leads to the development of codes, categories and themes based on the descriptions to culminate in hypotheses of how these themes interact. Atlas.ti v8.0 software was used for the data analysis (ATLAS.ti Scientific Software Development GmbH, Lietzenburger Str. 75, D-10719 Berlin, Germany).
Six researchers from the team collaborated in the analysis of the transcripts through an iterative process of intersubjective data triangulation sessions until definitive categories and guiding questions were reached regarding the phenomenon under study.
After the analysis, all participants received an email, who explained the findings and asked for feedback (member checking).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty participants included (surgeons n = 12, anesthetists n = 2, residents n = 2, nurses n = 2, technicians n = 2).
Key inclusion criteria (1 listed)
- Health members working in the operating room.
Key exclusion criteria (1 listed)
- Less than one year of experience in the operating room.
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 |
|---|---|---|
| In-depth individual interviewsIn-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management. | Other | – |
Primary outcome
Perceptions about the occurrence of disruptive behaviors and the work dynamics in the operating room
Time frame: Up to 45 minutes
In-depth individual interviews were based on a semistructured script designed to investigate the perceptions of the participants about the activity they performed, the ideal working conditions, the presence of disruptive behaviors, and their management
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 9 Nov 2021.
- Individual participant dataSharing planned: No. To protect the confidentiality of the participants, interview transcripts will not be shared.
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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?
An observational study of Disruptive Behavior, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 9 Nov 2021. 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 Chile. 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?
Perceptions about the occurrence of disruptive behaviors and the work dynamics in the operating room (time frame: Up to 45 minutes). 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 9 Nov 2021.