NursesRCIBONCT06938594
Working With Your Body in the Operating Room. The Case of Operating Room Nurses (RCIBO)
An observational study of Nurses and Operating Rooms, run by University Hospital, Brest at 1 site in France.
Trial summary
The undocumented observation, repeatedly observed in the operating rooms, of discomfort, including fainting, among medical and paramedical novices working in contact with surgical breaches raises questions about the mechanisms put in place to cope with what seems initially unimaginable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurses, Operating Rooms
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Operating room nurses
Who may be able to join
- operating room nurses
- Student nurses and operating room nurses
- Supervisors
- Doctors, interns and externs
- Surgeons
- Midwives and midwifery students
Show all 9Show fewer
- Hospital cleaning staff
- Nursing assistants
- Biomedical staff
Who cannot join
- People not involved in surgical operations
- People refusing to take part in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Working With Your Body in the Operating Room. The Case of Operating Room Nurses
The undocumented observation, repeatedly observed in the operating rooms, of discomfort, including fainting, among medical and paramedical novices working in contact with surgical breaches raises questions about the mechanisms put in place to cope with what seems initially unimaginable. Indeed, accounts in the social sciences show that the surgical opening of a living person is, in some ways, a transgressive act, forbidden outside the operating room. By spilling blood, it induces a 'symbolic disorder' described by Mary Douglas, that is contained through ritualized practices, predispositions towards objectification, and injunctions to control affects. The use of surgical drapes allows for the partial erasure of the person being operated on, who is no longer seen as a subject, but as an object of care - a dehumanized body or 'image-object' described by Amandine Klipfel. It is possible that ORNs are gradually adapting to negotiate the reconfiguration of bodies in the operating room, the transgression inherent in the surgical opening of a living person, and the personal resonance this may have for them. The investigator questions the specificities of their profession and their physical, emotional, and cognitive relationships following the initial shock of confronting open bodies. Is it possible to grow accustomed to or adapt to open bodies to the point of no longer experiencing difficulties related to what was once unthinkable? The investigator aims to understand what becomes of these initially unrepresentable experiences and roles ORNs have in redefining the bodies present - the processes of objectification and rehumanization of patients in the operating rooms. This doctoral study grasps the cognitive and imaginary constructions they experience in France and Canada.
- Conditions
- Nurses, Operating Rooms
- Keywords
- operating room nurses, opened bodies, surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
References to emotions in interviews
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (1)
Identification of body postures, verbal and non-verbal communication, reactions and interactions of professionals during observations in the operating rooms
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start27 Jan 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938594
- Sponsor's protocol ID
- 29BRC24.0311 - RCIBO
- Acronym
- RCIBO
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working With Your Body in the Operating Room. The Case of Operating Room Nurses
- ClinicalTrials.gov ID
- NCT06938594
- Acronym / sponsor ID
- RCIBO / 29BRC24.0311 - RCIBO
- Conditions
- Nurses, Operating Rooms
- Keywords
- operating room nurses, opened bodies, surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 Apr 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 undocumented observation, repeatedly observed in the operating rooms, of discomfort, including fainting, among medical and paramedical novices working in contact with surgical breaches raises questions about the mechanisms put in place to cope with what seems initially unimaginable. Indeed, accounts in the social sciences show that the surgical opening of a living person is, in some ways, a transgressive act, forbidden outside the operating room. By spilling blood, it induces a 'symbolic disorder' described by Mary Douglas, that is contained through ritualized practices, predispositions towards objectification, and injunctions to control affects. The use of surgical drapes allows for the partial erasure of the person being operated on, who is no longer seen as a subject, but as an object of care - a dehumanized body or 'image-object' described by Amandine Klipfel. It is possible that ORNs are gradually adapting to negotiate the reconfiguration of bodies in the operating room, the transgression inherent in the surgical opening of a living person, and the personal resonance this may have for them. The investigator questions the specificities of their profession and their physical, emotional, and cognitive relationships following the initial shock of confronting open bodies. Is it possible to grow accustomed to or adapt to open bodies to the point of no longer experiencing difficulties related to what was once unthinkable? The investigator aims to understand what becomes of these initially unrepresentable experiences and roles ORNs have in redefining the bodies present - the processes of objectification and rehumanization of patients in the operating rooms. This doctoral study grasps the cognitive and imaginary constructions they experience in France and Canada.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Operating room nurses
Key inclusion criteria (9 listed)
- operating room nurses
- Student nurses and operating room nurses
- Supervisors
- Doctors, interns and externs
- Surgeons
Key exclusion criteria (2 listed)
- People not involved in surgical operations
- People refusing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
References to emotions in interviews
Time frame: From enrollment to the end of treatment at 1 year
1 secondary outcome
Identification of body postures, verbal and non-verbal communication, reactions and interactions of professionals during observations in the operating rooms
Time frame: From enrollment to the end of treatment at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Nurses and Operating Rooms, run by University Hospital, Brest at 1 site in France.
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 9 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
References to emotions in interviews (time frame: From enrollment to the end of treatment at 1 year). 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 22 Apr 2025.