- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453736
Staff Experiences in Robotic Theatres
A Qualitative Study of Staff Experiences and Practices Within the Robotic Theatre Setup
Studies have shown that team work impacts patients safety. This is particularly the case in surgical theatres where individuals from different backgrounds (surgeon, anaesthetists, nurses, ..etc) work together to achieve a common goal which is looking after the patient. The robotic theatre set up is different due to the physical separation of the surgeon from the patient and the rest of the team. This may represent a communication challenge. The Study investigators aim to study theatre staff experiences and practices of communication and teamwork in this special setup, investigating any challenges participants may be facing and possible ways of adapting to them. Staff opinions and suggestions for improvement will be explored for utmost surgical performance and patient safety.
The study will involve two parts:1) individual staff interviews and 2) teamwork observations during real life surgery. The two parts should complement each other giving an overall picture of the teamwork in the robotic theatre setup.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Leicester, United Kingdom
- University Hospitals of Leicester NHS Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Robotic theatre staff as above.
- Willing and able to participate.
- Good command of the English language.
Exclusion Criteria:
- Theatre staff not involved in robotic surgery.
- Participants not willing / unable to participate.
- Staff that have not worked in a conventional theatre setup before.
- Inability to read/speak/understand English.
- Lack of capacity for consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Robotic procedures
Experiences and practices in Robotic theatres will be studied via semi-structured interviews with staff as well as team observations during real time robotic surgery.
As the study is a qualitative one, data collection will continue till we reach saturation of theoretical categories.
We expect 20 interviews and 10 observations to suffice.
|
This is a qualitative study involving staff interviews and observations.
No intervention is being applied.
|
|
Non-Robotic procedures
Staff involved in robotic surgery will have almost definitely worked in non-robotic theatres ie major abdominal and laparoscopic. Staff interviews will explore differences in experiences and practices between these different theatre setups. In addition, we aim to observe further 5 non-robotic procedures to evaluate staff teamwork and communication within the more regular theatre setup. |
This is a qualitative study involving staff interviews and observations.
No intervention is being applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Robotic staff experiences.
Time Frame: 1 year
|
This will be explored using individual interviews and team observations.
Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
|
1 year
|
|
Robotic staff practices
Time Frame: 1 year
|
This will be explored using individual interviews and team observations.
Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Staff communication in robotic theatres.
Time Frame: 1 year
|
This will be explored using individual interviews and team observations.
Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
|
1 year
|
|
Staff teamwork
Time Frame: 1 year
|
This will be explored using individual interviews and team observations.
Textual data of interview transcripts and observation field notes will be analysed using constant comparative method.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0647
- 237227 (Other Identifier: Integrated Research Application System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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