Impact of Anxiety on the Decision-making Processes of Anesthesiologists

Anxiety Clinical Trial

— DECIDINH  

Official title:

Impact of Anxiety on the Decision-making Process of Anesthesiologists in the Choice of Drugs for Induction of General Anesthesia of Patients With Aspiration Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364801
• Other study ID #: 2022/683
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: David FERREIRA, PH
• Phone: +33 3 81 66 91 31
• Email: dferreira[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Except for exaggerated situations in which aspiration risk seems obvious (or absent), the choice of a rapid sequence induction protocol for general anesthesia is often made under uncertainty, according to the individual assessment of the balance between the aspiration risk on one hand and the anaphylaxis risk induced by short-acting curares on the other hand. The impact of anxiety and impulsivity on the choice of induction protocols under uncertainty has never been studied before. In order to investigate this issue, an online anonymous survey has been designed and will be sent to the anesthesiologists of the Bourgogne Franche-Comté and Grand Est regions in France. The primary objective of this study is to assess the impact of trait-anxiety using the STAI-Y2 form on the decision-making process of anesthesiologists during the choice of an induction protocol for patients at risk of aspiration. The secondary objectives are to characterize decision-making profiles, to measure the implicit dimension of anxiety using an Implicit association test, to study the impact of impulsivity on decision-making processes under uncertainty using the short version of UPPS-P scale and to study the role of socio-demographic data and professional history in these decisions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all anesthesiologists who have completed their PhD
• working in France
• in a public or private healthcare facility

Exclusion Criteria:

• residents
• retired anesthesiologists

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Decision Making
• General Anesthesia

Intervention

Other:
• Survey
Online anonymous survey

Locations

Country	Name	City	State
France	CHU Besançon	Besançon	Doubs

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory Form Y2	Measure of STAI Y2. A score above the threshold of 49 out of 80 will display a trait-anxiety interfering with the decision-making of the anesthesiologists.	at 4 months
Secondary	Decision-making profiles	Characterize decision-making profiles using a survey of 10 clinical situations presenting a variable degree of uncertainty, for which a risk score (RS) has been determined by an expert committee. For each situation, the induction protocol must be chosen among a five-choice list gathered in 3 categories : (1) rapid sequence induction (hypnotic + short-acting curare), (2) short protocol (hypnotic + alfentanil or remifentanil) and (3) standard (hypnotic + sufentanil or remifentanil + cisatracurium). Each category has its own score, so that a protocol score (PS) is attributed to the chosen protocol. Finally, a global score (GS) is calculated for each subject by adding the product of RS x PS of the 10 situations.; The subjects will be attributed to one of the three profiles according to their global score.	at 4 months
Secondary	Implicit measure of anxiety	Measure of the anxiety using the Implicit association test.	at 4 months
Secondary	Impulsivity measure : (negative) Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation (seeking) - Positive (urgency) scale (UPPS-P scale)	Measure of the impulsivity using the short version of the UPPS-P scale which is the (negative) Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation (seeking) - Positive (urgency) scale.; This scale measures five dimensions of impulsivity. Each dimension will be scored and compared to the mean and standard deviation of the other profiles and to the mean and standard deviation of the general population.; A score above the mean of the general population shows a higher tendency to impulsive behaviours in the scored dimension. The higher the scores are, the more impulsive the subjects are.; Standard values for each dimension : Dimensions Mean Standard deviation Negative Urgency 9.38 2.73 Positive Urgency 10.84 2.38 Lack of premeditation 7.98 2.15 Lack of perseverance 7.46 2.41 Sensation seeking 10.55 2.72	at 4 months
Secondary	Socio-demographics and professional history	Collection of socio-demographic data : sex, experience, practice in anaesthesic wards where aspiration risk is frequently encountered (digestive OR, emergency OR, obstetrics), region, practice in a public or private facility, time spent on duty (hours per week), coffee and cigarette consumption at work, history of severe anaphylaxis resulting from a rapid sequence induction, history of aspiration resulting from an induction of general anesthesia, emotional issues of severe anaphylaxis or aspiration.	at 4 months

External Links

•   C. Schmitz. Workarounds: Manipulating a survey at runtime using Javascript - Implicit association test. Published February 16, 2022. Accessed March 13, 2022
•   Current guidelines from the French Society of Anaesthesia & Intensive Care Medicine for the airway management in anesthesiology of adults, except for difficult intubation
•   Muscle relaxants and reversal in anaesthesia. Guidelines from the French Society of Anaesthesia & Intensive Care Medicine
•   Rabault K, Master degree on the subject of the assessment of practice concerning the rapid sequence induction for patient at risk of aspiration in the Poitiers University Hospital