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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04346810
Other study ID # CSC19APR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date September 1, 2020

Study information

Verified date April 2020
Source Hôpital Raymond Poincaré
Contact Hakim Harkouk, M.D.
Phone 0033149095422
Email hakim.harkouk@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The intense health crisis due to COVID-19 led to a profound reorganization of the activities at theatres, recovery rooms and the intensive care units. The caregivers are facing several issues and are daily exposed to an intensification of the work. Assessing the stress and the well-being of the caregivers is very important in this context.


Description:

The current period of intense and prolonged health crisis has necessitated a profound reorganization of the activities and organizations of the intensive care hospital services in order to be able to cope with it.

Caregivers are at the heart of the management of this crisis and are exposed daily to these situations of repeated emergencies, an intensification of the pace of work and difficulties in care.

In this context, it seemed important to us to try to quantify this pressure of care, in order to be able to offer in second care adapted to caregivers who would like it.

The assessment of the mental state of the caregivers as well as the collection of the feelings and perceptions on the current crisis and its management will be carried out by anonymous and voluntary self-questionnaire in collaboration with the service of professional pathologies and occupational medicine of the hospital structure


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 1, 2020
Est. primary completion date August 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Consent to participation; caregivers working at recovery room; caregiver working at intensive care unit

Exclusion Criteria:

- refusal of participation

Study Design


Intervention

Other:
Patient management suffering of coronavirus infection
Welle-being and stress of the caregivers

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Hôpital Raymond Poincaré Clement DURET MD, Dominique FLETCHER MD-PhD, Guillaume GERI MD-PhD

References & Publications (2)

Pastores SM. Burnout Syndrome in ICU Caregivers: Time to Extinguish! Chest. 2016 Jul;150(1):1-2. doi: 10.1016/j.chest.2016.03.024. — View Citation

Staloff J, Diop M, Matuk R, Riese A, White J. Caring for Caregivers: Burnout and Resources for Caregivers in Rhode Island. R I Med J (2013). 2018 Nov 1;101(9):10-11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit stress level of caregivers managing patients with coronavirus infection needing airway support or resuscitation. The level of stress will be quantified with the Maslach burnout Inventory. A 3 months period from the starting of the pandemic
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