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OpenTrials
Completed

NCT Number: NCT03375073

Positive Communication and Clinical Performance in Anaesthetic Care.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Grenoble Alps

La Tronche, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive communication during medical transmission

Other

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

Primary outcomes

  1. Clinical performance of the anaesthetic team

    Time frame: 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

    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.

Secondary outcomes

  1. Heart rate variability

    Time frame: 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)

    Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants

  2. Self-reported stress

    Time frame: Before the scenario (at 5 min), after medical transmission (at 7 min), after the scenario (at 13 min), after debriefing (at 33 min)

    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%).

Sponsors and collaborators

Lead sponsor

University Grenoble Alps

Other

Registry information

Official study title

Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.

Acronym: ComPerf

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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