Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05113147 |
| Other study ID # |
15-340 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2018 |
| Est. completion date |
May 30, 2018 |
Study information
| Verified date |
October 2021 |
| Source |
Pontificia Universidad Catolica de Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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).
