Impact of Anxiety on the Decision-making Processes of Anesthesiologists (DECIDINH)

February 8, 2024 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Doubs
      • Besançon, Doubs, France, 25000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A first phase will include all anesthesiologists of Bourgogne-Franche-Comté and Grand-Est regions (500 subjects) A second phase will include all anesthesiologists registered in France.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • residents
  • retired anesthesiologists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory Form Y2
Time Frame: at 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision-making profiles
Time Frame: at 4 months

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
Implicit measure of anxiety
Time Frame: at 4 months
Measure of the anxiety using the Implicit association test.
at 4 months
Impulsivity measure : (negative) Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation (seeking) - Positive (urgency) scale (UPPS-P scale)
Time Frame: at 4 months

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
Socio-demographics and professional history
Time Frame: at 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: David FERREIRA, PH, Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be strictly anonymous.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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