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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03375073
Other study ID # CESAR001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2017
Est. completion date September 29, 2018

Study information

Verified date April 2019
Source University Grenoble Alps
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.


Description:

When caregivers deal with acute stressful adverse events, cognitive overload and negative emotions can impair cognitive abilities and decrease clinical performance. The beneficial effect of positive communication on patients' emotions has widely been studied. However, the emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The primary purpose of this trial is to study the impact of positive communication between anaesthetic teams during medical transmissions on clinical performance for managing a subsequent stressful unexpected adverse event. Secondary outcomes are to study the impact of positive communication on physiological (heart rate variability) and psychological (psychometric scales) levels of stress.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 29, 2018
Est. primary completion date June 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria

Anaesthetic teams composed with :

- 1 resident in anaesthesiology and critical care AND

- 1 anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago

Non-inclusion criteria

- Refusal to be videotaped

- No consent to participate

- Anaesthetic nurses working in a paediatric operating room.

Study Design


Intervention

Other:
Positive communication during medical transmission
Use of positive communication for medical transmission to the anaesthetic team who takes over the patient.

Locations

Country Name City State
France University Grenoble Alps La Tronche

Sponsors (1)

Lead Sponsor Collaborator
University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical performance of the anaesthetic team Clinical performance in a simulated scenario of laryngospasm occurring in a 7 year old child under general anaesthesia. Clinical performance will be scored from 0 to 100 by two independent blinded assessors, using video records and a pre-established scenario-specific checklist. The primary endpoint will be the mean of the two assessments for each performance. Each anaesthetic team will be involved once in the scenario. The scenario will last about 6 min (transmission not included). Both assessment of clinical performance will be made within 20 weeks of each simulation session
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants Before the scenario (during 5 min), during medical transmission (2 min), during the scenario before the laryngospasm (2 min), during the laryngospasm (4 min), during the debriefing (20 min), after the debriefing (5 min)
Secondary Self-reported stress Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%). Before the scenario (at 5 min), after medical transmission (at 7 min), after the scenario (at 13 min), after debriefing (at 33 min)
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