NCT06938594

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2025Nov 2028

Study Start

First participant enrolled

January 27, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

February 10, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

operating room nursesopened bodiessurgery

Outcome Measures

Primary Outcomes (1)

  • References to emotions in interviews

    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

    From enrollment to the end of treatment at 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Operating room nurses

You may qualify if:

  • operating room nurses
  • Student nurses and operating room nurses
  • Supervisors
  • Doctors, interns and externs
  • Surgeons
  • Midwives and midwifery students
  • Hospital cleaning staff
  • Nursing assistants
  • Biomedical staff

You may not qualify if:

  • People not involved in surgical operations
  • People refusing to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

April 22, 2025

Study Start

January 27, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations